amoxicillin-potassium-clavulanate-combination and Bacterial-Infections

Beta-lactam dose optimization in critical care is a current priority. We aimed to review the pharmacokinetics (PK) of three commonly used beta-lactams (amoxicillin ± clavulanate, piperacillin-tazobactam and meropenem) to compare PK parameters reported in critically and noncritically ill neonates, children and adults, and to investigate whether allometric and maturation scaling principles could be applied to describe changes in PK parameters through life.. A systematic review of PK studies of the three drugs was undertaken using MEDLINE and EMBASE. PK parameters and summary statistics were extracted and scaled using allometric principles to 70 kg individual for comparison. Pooled data were used to model clearance maturation and decline using a sigmoidal (Hill) function.. A total of 130 papers were identified. Age ranged from 29 weeks to 82 years and weight from 0.9-200 kg. PK parameters from critically ill populations were reported with wider confidence intervals than those in healthy volunteers, indicating greater PK variability in critical illness. The standard allometric size and sigmoidal maturation model adequately described increasing clearance in neonates, and a sigmoidal model was also used to describe decline in older age. Adult weight-adjusted clearance was achieved at approximately 2 years postmenstrual age. Changes in volume of distribution were well described by the standard allometric model, although amoxicillin data suggested a relatively higher volume of distribution in neonates.. Critical illness is associated with greater PK variability than in healthy volunteers. The maturation models presented will be useful for optimizing beta-lactam dosing, although a prospective, age-inclusive study is warranted for external validation.

Topics: Adult; Age Factors; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; beta-Lactamase Inhibitors; Biological Variation, Population; Child; Critical Illness; Dose-Response Relationship, Drug; Healthy Volunteers; Humans; Infant, Newborn; Meropenem; Microbial Sensitivity Tests; Piperacillin, Tazobactam Drug Combination

Acute rhinosinusitis is one of the most common conditions that physicians treat in ambulatory care. Most cases of acute rhinosinusitis are caused by viral upper respiratory infections. A meta-analysis based on individual patient data found that common clinical signs and symptoms were not effective for identifying patients with rhinosinusitis who would benefit from antibiotics. C-reactive protein and erythrocyte sedimentation rate are somewhat useful tests for confirming acute bacterial maxillary sinusitis. Four signs and symptoms that significantly increase the likelihood of a bacterial cause when present are double sickening, purulent rhinorrhea, erythrocyte sedimentation rate greater than 10 mm per hour, and purulent secretion in the nasal cavity. Although cutoffs vary depending on the guideline, antibiotic therapy should be considered when rhinosinusitis symptoms fail to improve within seven to 10 days or if they worsen at any time. First-line antibiotics include amoxicillin with or without clavulanate. Current guidelines support watchful waiting within the first seven to 10 days after upper respiratory symptoms first appear. Evidence on the use of analgesics, intranasal corticosteroids, and saline nasal irrigation for the treatment of acute rhinosinusitis is poor. Nonetheless, these therapies may be used to treat symptoms within the first 10 days of upper respiratory infection. Radiography is not recommended in the evaluation of uncomplicated acute rhinosinusitis. For patients who do not respond to treatment, computed tomography of the sinuses without contrast media is helpful to evaluate for possible complications or anatomic abnormalities. Referral to an otolaryngologist is indicated when symptoms persist after maximal medical therapy and if any rare complications are suspected.

Topics: Acute Disease; Administration, Intranasal; Adrenal Cortex Hormones; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Blood Sedimentation; C-Reactive Protein; Humans; Maxillary Sinusitis; Nasal Lavage; Rhinitis; Sinusitis; Tomography, X-Ray Computed; Virus Diseases; Watchful Waiting

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cephalexin; Ciprofloxacin; Clindamycin; Hand; Hand Dermatoses; Humans; Trimethoprim, Sulfamethoxazole Drug Combination

Acute otitis media (AOM) is diagnosed based on visualization of a full or bulging tympanic membrane with middle ear effusion. The distribution of bacteria causing AOM in North America under the influence of pneumococcal conjugate vaccination and antibiotic selection pressure has resulted in a predominance of β-lactamase-producing Haemophilus influenzae followed by penicillin-resistant Streptococcus pneumoniae. Although guidelines continue to endorse amoxicillin as the preferred treatment, amoxicillin/clavulanate in high dosage would be the preferred treatment based on the otopathogen mix currently. Antibiotic prophylaxis has fallen into disfavor as a preventative strategy for AOM recurrences.

Topics: Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefdinir; Cefpodoxime Proxetil; Ceftizoxime; Cefuroxime; Cephalosporins; Child; Child, Preschool; Haemophilus influenzae; Humans; Infant; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media; Otitis Media with Effusion; Otoscopy; Streptococcus pneumoniae; Time Factors; Tympanic Membrane

On the basis of strong research evidence, the pathogenesis of sinusitis involves 3 key factors: sinusostia obstruction, ciliary dysfunction, and thickening of sinus secretions. On the basis of studies of the microbiology of otitis media, H influenzae is playing an increasingly important role in the etiology of sinusitis, exceeding that of S pneumoniae in some areas, and b-lactamase production by H influenzae is increasing in respiratory isolates in the United States. On the basis of some research evidence and consensus,the presentation of acute bacterial sinusitis conforms to 1 of 3 predicable patterns; persistent, severe, and worsening symptoms. On the basis of some research evidence and consensus,the diagnosis of sinusitis should be made by applying strict clinical criteria. This approach will select children with upper respiratory infection symptoms who are most likely to benefit from an antibiotic. On the basis of some research evidence and consensus,imaging is not indicated routinely in the diagnosis of sinusitis. Computed tomography or magnetic resonance imaging provides useful information when complications of sinusitis are suspected. On the basis of some research evidence and consensus,amoxicillin-clavulanate should be considered asa first-line agent for the treatment of sinusitis.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Diagnosis, Differential; Humans; Respiratory Tract Infections; Sinusitis; Virus Diseases

Bacterial infections are well described complications of cirrhosis that greatly increase mortality rates. Two factors play important roles in the development of bacterial infections in these patients: the severity of liver disease and gastrointestinal haemorrhage. The most common infections are spontaneous bacterial peritonitis, urinary tract infections, pneumonia and sepsis. Gram-negative and gram-positive bacteria are equal causative organisms. For primary prophylaxis, short-term antibiotic treatment (oral norfloxacin or ciprofloxacin) is indicated in cirrhotic patients (with or without ascites) admitted with gastrointestinal haemorrhage (variceal or non-variceal). Administration of norfloxacin is advisable for hospitalized patients with low ascitic protein even without gastrointestinal haemorrhage. The first choice in empirical treatment of spontaneous bacterial peritonitis is the iv. III. generation cephalosporin; which can be switched for a targeted antibiotic regime based on the result of the culture. The duration of therapy is 5-8 days. Amoxicillin/clavulanic acid and fluoroquinolones--patients not on prior quinolone prophylaxis--were shown to be as effective and safe as cefotaxime. In patients with evidence of improvement, iv. antibiotics can be switched safely to oral antibiotics after 2 days. In case of renal dysfunction, iv albumin should also be administered. Long-term antibiotic prophylaxis is recommended in patients who have recovered from an episode of spontaneous bacterial peritonitis (secondary prevention). For "selective intestinal decontamination", poorly absorbed oral norfloxacin is the preferred schedule. Oral ciprofloxacin or levofloxacin (added gram positive spectrum) all the more are reasonable alternatives. Trimethoprim/sulfamethoxazole is only for patients who are intolerant to quinolones. Prophylaxis is indefinite until disappearance of ascites, transplant or death. Long-term prophylaxis is currently not recommended for patients without previous spontaneous bacterial peritonitis episode, not even when refractory ascites or low ascites protein content is present.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Ascites; Bacteremia; Bacterial Infections; Cefotaxime; Cephalosporins; Ciprofloxacin; Fluoroquinolones; Gastrointestinal Hemorrhage; Humans; Infusions, Intravenous; Liver Cirrhosis; Norfloxacin; Peritonitis; Pneumonia, Bacterial; Primary Prevention; Severity of Illness Index; Trimethoprim, Sulfamethoxazole Drug Combination; Urinary Tract Infections

Antibiotics are commonly used in dental practice. It has been estimated that 10% of all antibiotic prescriptions are related with dental infections. The association amoxicillin-clavulanate was the drug most frequently prescribed by dentists during 2005, at least in the Valencian Community (Spain). The use of antibiotics in dental practice is characterized by empirical prescription based on clinical and bacteriological epidemiological factors, with the use of broad spectrum antibiotics for short periods of time, and the application of a very narrow range of antibiotics. The simultaneous prescription of nonsteroidal antiinflammatory drugs (NSAIDs) can modify the bioavailability of the antibiotic. In turn, an increased number of bacterial strains resistant to conventional antibiotics are found in the oral cavity. Antibiotics are indicated for the treatment of odontogenic infections, oral non-odontogenic infections, as prophylaxis against focal infection, and as prophylaxis against local infection and spread to neighboring tissues and organs. Pregnancy, kidney failure and liver failure are situations requiring special caution on the part of the clinician when indicating antibiotic treatment. The present study attempts to contribute to rational antibiotic use, with a review of the general characteristics of these drugs.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Bacterial Infections; Contraindications; Drug Resistance, Bacterial; Humans; Mouth Diseases; Practice Patterns, Dentists'

Infections are currently ranked as the leading global burden of disease with respiratory diseases playing the most significant role. Antibiotic resistance remains a serious problem, as it was even 50 years ago. The 1970s saw the introduction of a number of important new antimicrobial agents, such as amoxicillin, but despite a high level of clinical success, a serious mechanism of resistance had emerged which could render the penicillins inactive - beta-lactamase production. In 1972, a potent inhibitor of beta-lactamase was identified. It was produced by Streptococcus clavuligerus and named clavulanic acid. Amoxicillin, with its good oral absorption and broad spectrum antimicrobial activity, was chosen as the antibiotic to be co-administered with clavulanic acid and, in tablet formulation, was launched as Augmentin in the UK in 1981. Today, although there are currently new antibacterial compounds in development, most are at a pre-clinical stage. It is thus necessary to make the best use of currently available agents. The development of higher dosing regimens and pharmacokinetically-enhanced formulations has allowed amoxicillin/clavulanate to continue to play an important role in the treatment of a range of infections, particularly those of the respiratory tract, in both adults and children worldwide.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; beta-Lactam Resistance; beta-Lactamase Inhibitors; History, 20th Century; Humans

During the last 10-15 years understanding of relationships between pharmacokinetic (PK) and pharmacodynamic (PD) parameters and bacteriological and clinical outcomes has expanded allowing correlation between in vitro potency and in vivo efficacy. PK and PD principles can be applied to development of new antibacterials and formulation of existing agents to help address the increasing prevalence of antibacterial resistance. For beta-lactams, such as penicillins, the unbound serum concentration of the drug exceeding the minimum inhibitory concentration of the causative pathogen for 40-50% of the dosing interval is predictive of bacteriologic efficacy (bacterial eradication) and can be used to determine a PK/PD breakpoint for that specific dosing regimen. Amoxicillin/clavulanate was one of the earliest antibacterials to use the unique approach of PK/PD principles to develop new and enhanced formulations, allowing it to remain a significant antibacterial agent in the management of respiratory tract infections.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Humans

Amoxicillin/clavulanate was first launched as a three times daily dosage for the treatment of a range of community-acquired infections. A decade later, it became necessary to introduce a twice daily dosage for reasons of convenience, compliance and to remain competitive with other recently launched antibacterials. Twice daily formulations of amoxicillin/clavulanate were developed in which the amount of amoxicillin was increased relative to clavulanate to provide equivalent bacteriological and clinical efficacy with no change in the safety profile. Equivalence of the two dosing regimens was confirmed by randomised clinical trials in adults (in skin and soft tissue, urinary tract and lower respiratory tract infections, sinusitis and recurrent tonsillitis) and paediatrics (in lower respiratory tract infections, otitis media and recurrent tonsillitis). An improvement in the safety profile, specifically gastrointestinal effects, due to the reduced daily dose of clavulanate, was noted for all patients, but particularly in children.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; History, 20th Century; Humans

By the 1960s and 1970s, problems in the antibacterial treatment of infections had begun to emerge. Previously active antibacterials were being compromised by the development of resistance. Beta-lactamase production was identified in isolates of staphylococci, and, amongst others, in Escherichia coli, Proteus mirabilis, Haemophilus influenzae and Moraxella catarrhalis. The discovery of the potent beta-lactamase inhibitor clavulanic acid, and its protective effect on amoxicillin, a semi-synthetic penicillin with good oral absorption and potent broad-spectrum antimicrobial activity, was thus of great importance in the treatment of bacterial disease. Following preliminary clinical studies in bronchitis and urinary tract infections, amoxicillin/clavulanate therapy was investigated in a wide range of infections and proved to demonstrate a high level of clinical efficacy. These results supported the launch of amoxicillin/clavulanate (Augmentin) in 1981 for use in upper and lower respiratory tract infections, urinary tract infections, skin and soft tissue infections and obstetric, gynaecological and intra-abdominal infections.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; beta-Lactam Resistance; beta-Lactamase Inhibitors; Community-Acquired Infections; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections; History, 20th Century; History, 21st Century; Humans

Since most infectious microorganisms inevitably develop resistance to any agents used to combat them, there has been a constant need to produce improved, more potent, antimicrobials. At least in part, the emergence and spread of resistant organisms has been provoked by inappropriate over-use of antibacterials. In the last decade, many fewer new antibacterials have been developed but overall prescribing has continued to increase. Consensus prescribing principles have now been defined with the aim of optimising therapy and preventing further increases in, or even to prompt a reduction in, the prevalence of resistance to antibacterial agents. Whilst it is important to encourage continued development of new classes of antibacterials, it is also vital to make the best use of available agents. The development of new dosages and formulations of amoxicillin/clavulanate allows this agent to continue to fill the important role in therapy which it has occupied, and continues to occupy, 25 years after it was launched.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Drug Resistance, Bacterial; History, 20th Century; History, 21st Century; Humans

The science of antibiotic therapy for infectious diseases continues to evolve. In many instances where empiric coverage is necessary, treatment with more than one agent is considered prudent. If an etiology is identified, antibiotics are modified based on culture and susceptibility data. Even when the organism is known, more than one antibiotic may be needed. Decisions about antibiotics should be made after assessments of pertinent clinical information, laboratory and microbiology information, ease of administration, patient compliance, potential adverse effects, cost, and available evidence supporting various treatment options. Clinicians also need to consider synergy and local resistance patterns in selecting therapeutic options. In this article, the authors outline monotherapy and combination therapy options for several common infectious diseases.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cellulitis; Cephalosporins; Ciprofloxacin; Diverticulitis; Drug Therapy, Combination; Endocarditis, Bacterial; Enterococcus faecalis; Humans; Meningitis, Bacterial; Neutropenia; Osteomyelitis; Pneumonia; Staphylococcus aureus; Viridans Streptococci

Amoxicillin/clavulanic acid 2000mg/125mg extended release (Augmentin XR), referred to herein as amoxicillin/clavulanic acid XR, is a pharmacokinetically enhanced formulation designed to provide more effective therapy in adults and adolescents than conventional formulations against community-acquired respiratory tract pathogens, particularly Streptococcus pneumoniae, with reduced susceptibility to amoxicillin. Amoxicillin/clavulanic acid XR maintains plasma amoxicillin concentrations above 4 microg/mL for a mean of 49% of the dosing interval indicating that it would be highly effective against S. pneumoniae strains with minimum inhibitory concentrations (MICs) above the National Committee for Clinical Laboratory Standard's amoxicillin +/- clavulanic acid susceptibility breakpoint of < or =2 microg/mL. Amoxicillin/clavulanic acid XR is at least as effective as conventional amoxicillin/clavulanic acid formulations, levofloxacin and clarithromycin in treating community-acquired pneumonia, acute bacterial sinusitis or acute exacerbations of chronic bronchitis, and has a tolerability profile comparable to that of conventional amoxicillin/clavulanic acid formulations. While the incidence of amoxicillin- or multidrug-resistant S. pneumoniae is not currently sufficient in most regions to warrant the routine empirical use of amoxicillin/clavulanic acid XR, the drug would be extremely useful in those regions with a high incidence of resistant pathogens or in selected patients (i.e. those with S. pneumoniae isolates having amoxicillin MICs > or =2 microg/mL but < or =4 microg/mL).

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Delayed-Action Preparations; Humans; Respiratory Tract Infections

This study evaluates the efficacy of various antimicrobial treatments for orofacial infections on the basis of pharmacokinetic/pharmacodynamic (PK/PD) criteria.. A complete a literature search was undertaken to establish the MIC90 values of the five microorganisms most frequently isolated in odontogenic infections and the pharmacokinetic parameters of 13 antibiotics used in these infections. Pharmacokinetic simulations were then carried out with mean population parameters and efficacy indexes were calculated for the 47 treatment regimens analyzed. For drugs showing time-dependent antibacterial killing, the time above MIC (t > MIC) was calculated. For drugs with concentration-dependent bactericidal activity, the AUC/MIC was calculated.. Amoxicillin-clavulanic (500 mg/8 h or 1000 mg/12 h) and clindamycin (300 mg/6 h) in the time-dependent killing group and moxifloxacin (400 mg/24 h) in the concentration-dependent group showed adequate efficacy indexes against the five pathogens considered to be the most commonly implicated in odontogenic infections. The spiramycin plus metronidazole combination, present in the commercial formulation Rhodogyl, did not reach satisfactory PK/PD indexes.. PK/PD indexes, which are useful predictors of the potential efficacy of antibacterial therapy, were used with ontogenic infections in the present study. The PK/PD simulations showed that amoxicillin-clavulanic, clindamycin and moxifloxacin were the most suitable antibiotics for this kind of infection. Clinical trials are required to confirm that this methodology is useful in these pathologic processes.

Topics: Algorithms; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Area Under Curve; Aza Compounds; Bacterial Infections; Clindamycin; Clinical Trials as Topic; Dose-Response Relationship, Drug; Drug Therapy, Combination; Fluoroquinolones; Fusobacterium nucleatum; Humans; Microbial Sensitivity Tests; Mouth Diseases; Moxifloxacin; Peptostreptococcus; Periodontitis; Porphyromonas gingivalis; Prevotella intermedia; Quinolines; Time Factors; Viridans Streptococci

THE CONTEXT: Up until the nineties, the intravenous administration of a broad spectrum antibiotic was the classical treatment of any patient presenting with febrile neutropenia. Since then, in patients considered at low risk and with expected of neutropenia less than 7-10 days, oral antibiotherapy has become an attractive option. TWO LARGE STUDIES: A study by the antimicrobial group of the EORTC (European organisation for research and treatment of cancer) and a North American study have compared the efficacy of an oral combination of ciprofloxacine and amoxicillin/clavulanic acid with that of an intravenous antibiotherapy in low-risk patients presenting febrile neutropenia. In both studies, the success rate was the same in the group of patients treated with oral antibiotics and those treated with intravenous antibiotics. RESERVATIONS: These two studies were conducted in hospitalised patients. No conclusions can be drawn with regard to out-patient treatment. Out-patient management would only be possible after appropriate selection of patients at low risk.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Ceftazidime; Ciprofloxacin; Drug Therapy, Combination; Europe; Fever; Hematologic Neoplasms; Humans; Immunocompromised Host; Infusions, Intravenous; Inpatients; Multicenter Studies as Topic; Neoplasms; Neutropenia; Randomized Controlled Trials as Topic; Risk; Treatment Outcome; United States

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Clinical Trials as Topic; Drug Therapy, Combination; Evaluation Studies as Topic; Female; Genital Diseases, Female; Gonorrhea; Humans; Respiratory Tract Infections

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Drug Therapy, Combination; Humans

The antibiotic co-amoxiclav (Augmentin-SmithKline Beecham) was first launched in the UK in 1981. When we reviewed it in 1982, we recommended it as second-line treatment for urinary infections and concluded that its place in other infections was unclear. Here we reassess the value of co-amoxiclav.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Animals; Bacterial Infections; Clavulanic Acids; Humans

Human bites to the hand or penetrating injuries contaminated with saliva can be a source of aggressive infection and debilitating injury. These types of injuries may also be a mode for the transmission of disease, notably hepatitis B. Dental personnel have an increased risk of experiencing bite injuries and should understand the general principles of appropriate management. Staphylococcal or streptococcal species are often associated with infected bite injuries, and amoxicillin and clavulanate are currently advised for prophylaxis. Wound cleansing and careful monitoring, combined with appropriate prophylaxis, are the mainstays of treatment.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Bacterial Infections; Bites, Human; Clavulanic Acids; Dentistry; Drug Therapy, Combination; Hand Injuries; Humans; Occupational Diseases

Cefprozil was evaluated in four multicentre comparative studies in the treatment of acute respiratory tract infections. In two studies, cefprozil 500 mg q. 12 hours was compared to cefaclor 500 mg q. eight hours for ten days of therapy. Randomization was on a 2:1 (cefprozil:cefaclor) basis in the European centres and 1:1 in North America. The clinical efficacy in acute bronchitis was 88% (284 out of 324 patients) for cefprozil and 88% (183 out of 208) for cefaclor, with successful bacteriological eradication of the causative pathogen in 86% and 82% of the patients, respectively. Amongst the patients with acute exacerbations of chronic bronchitis, the clinical response rate of 80% (59 out of 74) for cefprozil appeared superior to that of cefaclor at 62% (p = 0.067), whilst the bacteriological response rates were 62% (36 out of 58) for cefprozil and 74% (20 out of 27) for cefaclor. In pneumonia, the clinical response rates for cefprozil and cefaclor therapy were similar, 82% vs. 79%, although bacteriological eradication rates were better for cefprozil at 82% than for cefaclor at 71%. In the comparison of cefprozil with cefuroxime axetil, a total of 170 patients were evaluable. The clinical and bacteriological response rates for cefprozil of 95% and 100% were better than those for cefuroxime axetil 500 mg q. 12 hours of 84% and 75%, respectively. In the cefprozil vs. amoxicillin-clavulanate, 500 mg q. eight hours comparative study, the two antibiotics displayed no significant difference in clinical or bacteriological responses.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis; Cefaclor; Cefprozil; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Multicenter Studies as Topic; Pneumonia; Prodrugs; Randomized Controlled Trials as Topic; Respiratory Tract Infections

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Multicenter Studies as Topic; Otitis Media; Randomized Controlled Trials as Topic

Six multicenter clinical trials comparing cefprozil with cefaclor, amoxicillin-clavulanate or erythromycin in the management of skin and soft-tissue infections caused by susceptible bacteria demonstrate that cefprozil, given once or twice daily, is an effective chemotherapeutic agent in this context. Its pharmacokinetic behavior is compatible with once-daily or twice-daily administration, with a probability of improved patient compliance. Safety and tolerability compare favorably with other agents used in skin and soft-tissue infections.

Topics: Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Drug Therapy, Combination; Erythromycin; Female; Humans; Male; Middle Aged; Multicenter Studies as Topic; Skin Diseases, Bacterial; Soft Tissue Infections

The efficacy and safety of a once-a-day antibiotic in the treatment of sinusitis was studied. Two randomly assigned groups were treated with either once-a-day cefixime, a third generation cephalosporin, or amoxicillin three times a day. One hundred and fourteen patients were evaluated with antral punctures, microbiologic evaluation, and radiographic studies. Cultures revealed 40% gram-negative organisms, 48% gram-positive, and 12% anaerobes. The most common bacteria were Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus and viridans group streptococci. Ninety-four percent of the cefixime group were cured compared with 96% of the amoxicillin group. Staphylococcus resistance was a problem in both groups, necessitating an occasional change to amoxicillin-clavulanate potassium in the amoxicillin group. Once-a-day antibiotics offer the potential for improved compliance in the treatment of sinusitis. Cefixime offers an additional benefit of covering beta-lactamase producing strains of bacteria which are increasing in incidence and resistant to many penicillins.

Topics: Administration, Oral; Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Capsules; Cefixime; Cefotaxime; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Remission Induction; Sinusitis; Time Factors

The arrival of new cephalosporins faces the clinician with an evergrowing confusion as to the drug of choice. The older agents (cephalexin, cephradine, cefadroxil and cefaclor) and the newer formulations cefatrizine and cefuroxime axetil are intensively used for treatment of mild and moderate infections. The oldest agents have a better pharmacokinetic profile but are less active against Gram-positives and Gram-negatives. Cefaclor, cefatrizine and cefuroxime axetil have improved in vitro activity against H. influenzae and/or against S. aureus and M. catarrhalis. However the mean free serum concentrations after proposed standard daily doses of cefaclor (3 x 250 mg/d), cefatrizine (2 x 500 mg/d) and cefuroxime-axetil (2 x 250 mg/d) are lower than those of the older cephalosporins. In comparison amoxicillin-clavulanate is equally efficacious, has a more reliable pharmacokinetic profile and is less expensive than cefaclor and cefuroxime axetil in a comparable dose (e.g. 3 x 500 mg/d).

Topics: Administration, Oral; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Humans; Respiratory Tract Infections; Skin Diseases, Infectious; Structure-Activity Relationship

The efficacy of amoxycillin-clavulanic acid as antibiotic prophylaxis in surgery has been assessed in numerous clinical studies, chiefly in abdominal and gynaecological surgery. A meta-analysis of 21 trials covering 2685 patients given amoxycillin-clavulanic acid and 2220 patients given comparator regimens is presented. Monotherapy with amoxycillin-clavulanic acid was as effective as the comparators, including combination regimens utilizing gentamicin or metronidazole, in preventing wound infections (median wound infection rates were 6% and 10% respectively). The antibacterial activity of amoxycillin-clavulanic acid covers the broad range of aerobic Gram-negative and anaerobic organisms that have a major role in postoperative infections. In addition, amoxycillin-clavulanic acid may have benefits in terms of convenience, tolerance and cost.

Topics: Abdomen; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Genitalia, Female; Humans; Surgical Wound Infection

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Clavulanic Acids; Drug Therapy, Combination; Drug Tolerance; Female; Humans; Infant, Newborn; Male; Surgical Wound Infection

The treatment of bacterial pneumonia requires an agent with activity against a wide range of bacterial pathogens, including pathogens that produce beta-lactamase. Loracarbef, a member of the carbacephem class of antibiotics, was tested in a series of clinical trials for its efficacy and safety in the treatment of lobar and bronchial bacterial pneumonia. Successful clinical responses were achieved in 97.6% of the evaluable patients receiving 400 mg twice daily of loracarbef. This compared favorably with the respective response rates of 92.3% for patients receiving 500 mg three times a day of amoxicillin/clavulanate and 95.0% for patients receiving 500 mg three times a day of amoxicillin for the same illnesses. Proven or presumed elimination of the pretherapy pathogen was found in 89% of the patients receiving loracarbef, 92.3% of the amoxicillin/clavulanate-treated patients, and 70.0% of those receiving amoxicillin. Loracarbef was also well tolerated, although nausea and vomiting were associated with the use of all three agents. Nevertheless, treatment with loracarbef resulted in the lowest rate of discontinuation of therapy due to drug-related adverse events. Thus, these clinical trials support the conclusion that loracarbef is a safe and effective treatment for bacterial pneumonia.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Humans; Nausea; Pneumonia; Randomized Controlled Trials as Topic; Vomiting

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Clinical Trials as Topic; Humans; Staphylococcal Infections; Streptococcal Infections

Switching from intravenous antibiotic therapy to oral antibiotic therapy among neonates is not yet practised in high-income settings due to uncertainties about exposure and safety. We aimed to assess the efficacy and safety of early intravenous-to-oral antibiotic switch therapy compared with a full course of intravenous antibiotics among neonates with probable bacterial infection.. In this multicentre, randomised, open-label, non-inferiority trial, patients were recruited at 17 hospitals in the Netherlands. Neonates (postmenstrual age ≥35 weeks, postnatal age 0-28 days, bodyweight ≥2 kg) in whom prolonged antibiotic treatment was indicated because of a probable bacterial infection, were randomly assigned (1:1) to switch to an oral suspension of amoxicillin 75 mg/kg plus clavulanic acid 18·75 mg/kg (in a 4:1 dosing ratio, given daily in three doses) or continue on intravenous antibiotics (according to the local protocol). Both groups were treated for 7 days. The primary outcome was cumulative bacterial reinfection rate 28 days after treatment completion. A margin of 3% was deemed to indicate non-inferiority, thus if the reinfection rate in the oral amoxicillin-clavulanic acid group was less than 3% higher than that in the intravenous antibiotic group the null hypothesis would be rejected. The primary outcome was assessed in the intention-to-treat population (ie, all patients who were randomly assigned and completed the final follow-up visit on day 35) and the per protocol population. Safety was analysed in all patients who received at least one administration of the allocated treatment and who completed at least one follow-up visit. Secondary outcomes included clinical deterioration and duration of hospitalisation. This trial was registered with ClinicalTrials.gov, NCT03247920, and EudraCT, 2016-004447-36.. Between Feb 8, 2018 and May 12, 2021, 510 neonates were randomly assigned (n=255 oral amoxicillin-clavulanic group; n=255 intravenous antibiotic group). After excluding those who withdrew consent (n=4), did not fulfil inclusion criteria (n=1), and lost to follow-up (n=1), 252 neonates in each group were included in the intention-to-treat population. The cumulative reinfection rate at day 28 was similar between groups (one [<1%] of 252 neonates in the amoxicillin-clavulanic acid group vs one [<1%] of 252 neonates in the intravenous antibiotics group; between-group difference 0 [95% CI -1·9 to 1·9]; p. An early intravenous-to-oral antibiotic switch with amoxicillin-clavulanic acid is non-inferior to a full course of intravenous antibiotics in neonates with probable bacterial infection and is not associated with an increased incidence of adverse events.. The Netherlands Organization for Health Research and Development, Innovatiefonds Zorgverzekeraars, and the Sophia Foundation for Scientific Research.

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acid; Humans; Infant; Infant, Newborn; Reinfection; Research; Treatment Outcome; Young Adult

High morbidity and mortality rates of proven bacterial infection are the main reason for substantial use of intravenous antibiotics in neonates during the first week of life. In older children, intravenous-to-oral switch after 48 hours of intravenous therapy has been shown to have many advantages and is nowadays commonly practised. We, therefore, aim to evaluate the effectiveness, safety and cost-effectiveness of an early intravenous-to-oral switch in neonates with a probable bacterial infection.. We present a protocol for a multicentre randomised controlled trial assessing the non-inferiority of an early intravenous-to-oral antibiotic switch compared with a full course of intravenous antibiotics in neonates (0-28 days of age) with a probable bacterial infection. Five hundred and fifty patients will be recruited in 17 hospitals in the Netherlands. After 48 hours of intravenous treatment, they will be assigned to either continue with intravenous therapy for another 5 days (control) or switch to amoxicillin/clavulanic acid suspension (intervention). Both groups will be treated for a total of 7 days. The primary outcome will be bacterial (re)infection within 28 days after treatment completion. Secondary outcomes are the pharmacokinetic profile of oral amoxicillin/clavulanic acid, the impact on quality of life, cost-effectiveness, impact on microbiome development and additional yield of molecular techniques in diagnosis of probable bacterial infection.. This study has been approved by the Medical Ethics Committee of the Erasmus Medical Centre. Results will be presented in peer-reviewed journals and at international conferences.. NCT03247920.

Topics: Administration, Intravenous; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Clinical Protocols; Cost-Benefit Analysis; Follow-Up Studies; Gastrointestinal Microbiome; Humans; Infant, Newborn; Netherlands; Patient Safety; Single-Blind Method; Treatment Outcome

The recommended treatment for acute bacterial sinusitis in adults, amoxicillin with clavulanate, provides only modest benefit.. To see if a higher dose of amoxicillin will lead to more rapid improvement.. Double-blind randomized trial in which, from November 2014 through February 2017, we enrolled 315 adult outpatients diagnosed with acute sinusitis in accordance with Infectious Disease Society of America guidelines.. Standard-dose (SD) immediate-release (IR) amoxicillin/clavulanate 875 /125 mg (n = 159) vs. high-dose (HD) (n = 156). The original HD formulation, 2000 mg of extended-release (ER) amoxicillin with 125 mg of IR clavulanate twice a day, became unavailable half way through the study. The IRB then approved a revised protocol after patient 180 to provide 1750 mg of IR amoxicillin twice a day in the HD formulation and to compare Time Period 1 (ER) with Time Period 2 (IR).. The primary outcome was the percentage in each group reporting a major improvement-defined as a global assessment of sinusitis symptoms as "a lot better" or "no symptoms"-after 3 days of treatment.. Major improvement after 3 days was reported during Period 1 by 38.8% of ER HD versus 37.9% of SD patients (P = 0.91) and during Period 2 by 52.4% of IR HD versus 34.4% of SD patients, an effect size of 18% (95% CI 0.75 to 35%, P = 0.04). No significant differences in efficacy were seen at Day 10. The major side effect, severe diarrhea at Day 3, was reported during Period 1 by 7.4% of HD and 5.7% of SD patients (P = 0.66) and during Period 2 by 15.8% of HD and 4.8% of SD patients (P = 0.048).. Adults with clinically diagnosed acute bacterial sinusitis were more likely to improve rapidly when treated with IR HD than with SD but not when treated with ER HD. They were also more likely to suffer severe diarrhea. Further study is needed to confirm these findings.. ClinicalTrials.gov Identifier: NCT02340000.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Diarrhea; Dose-Response Relationship, Drug; Double-Blind Method; Drug Resistance, Microbial; Female; Humans; Male; Medication Adherence; Middle Aged; Sinusitis; Treatment Outcome; Vaginitis

The purpose of this study was to compare the use of amoxicillin (1g) vs amoxicillin and clavulanate (875/125mg) after extraction of retained third molars for prevention of infectious complications.. The study involved 546 patients attending for removal a retained third molar and divided in to two groups: Group 1 - amoxicillin and clavunate (875/125mg) group (n=257) and Group 2 - amoxicillin (1g) group (n=289). All patients were recalled for investigating the possibility of infection, presence of diarrhea and further analgesic intake.. From a total of 546 patients, the frequency of infection was 1.4%, without no statistically differences between the two groups. Group 1 showed statistically higher presence of patients with gastrointestinal complications (p>0.05). In 546 patients, 2.7% of patients reported severe pain that would not relieve with medication.. The results of our study show that the use of amoxicillin (1g) and amoxicillin and clavunate (875/125mg) is similar efficacious in preventing infection after retained third molar extraction but amoxicillin and clavunate (875/125mg) produces more gastrointestinal discomfort.

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; beta-Lactamase Inhibitors; Female; Humans; Male; Molar, Third; Postoperative Complications; Tooth Extraction

Ninety percent of cases of acute calculous cholecystitis are of mild (grade I) or moderate (grade II) severity. Although the preoperative and intraoperative antibiotic management of acute calculous cholecystitis has been standardized, few data exist on the utility of postoperative antibiotic treatment.. To determine the effect of postoperative amoxicillin plus clavulanic acid on infection rates after cholecystectomy.. A total of 414 patients treated at 17 medical centers for grade I or II acute calculous cholecystitis and who received 2 g of amoxicillin plus clavulanic acid 3 times a day while in the hospital before and once at the time of surgery were randomized after surgery to an open-label, noninferiority, randomized clinical trial between May 2010 and August 2012.. After surgery, no antibiotics or continue with the preoperative antibiotic regimen 3 times daily for 5 days.. The proportion of postoperative surgical site or distant infections recorded before or at the 4-week follow-up visit.. An imputed intention-to-treat analysis of 414 patients showed that the postoperative infection rates were 17% (35 of 207) in the nontreatment group and 15% (31 of 207) in the antibiotic group (absolute difference, 1.93%; 95% CI, -8.98% to 5.12%). In the per-protocol analysis, which involved 338 patients, the corresponding rates were both 13% (absolute difference, 0.3%; 95% CI, -5.0% to 6.3%). Based on a noninferiority margin of 11%, the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment. Bile cultures showed that 60.9% were pathogen free. Both groups had similar Clavien complication severity outcomes: 195 patients (94.2%) in the nontreatment group had a score of 0 to I and 2 patients (0.97%) had a score of III to V, and 182 patients (87.8%) in the antibiotic group had a score of 0 to I and 4 patients (1.93%) had a score of III to V.. Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics, lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections.. clinicaltrials.gov Identifier: NCT01015417.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cholecystectomy; Cholecystitis, Acute; Female; Humans; Male; Middle Aged; Postoperative Care; Postoperative Complications; Treatment Outcome; Young Adult

The aim was to compare the efficacy and safety of two antibiotic regimens in patients with diabetic foot infections (DFIs).. Data of a subset of patients enrolled in the RELIEF trial with DFIs requiring surgery and antibiotics were evaluated retrospectively. DFI was diagnosed on the basis of the modified Wagner, University of Texas, and PEDIS classification systems. Patients were randomized to receive either intravenous/oral moxifloxacin (MXF, N = 110) 400 mg q.d. or intravenous piperacillin/tazobactam 4.0/0.5 g t.d.s. followed by oral amoxicillin/clavulanate 875/125 mg b.d. (PIP/TAZ-AMC, N = 96), for 7-21 days until the end of treatment (EOT). The primary endpoint was clinical cure rates in the per-protocol (PP) population at the test-of-cure visit (TOC, 14-28 days after EOT).. There were no significant differences between the demographic characteristics of PP patients in either treatment group. At TOC, MXF and PIP/TAZ-AMC had similar efficacy in both the PP and intent-to-treat (ITT) populations: MXF: 76.4 % versus PIP/TAZ-AMC: 78.1 %; 95 % confidence interval (CI) -14.5 %, 9.0 % in the PP population; MXF: 69.9 % versus PIP/TAZ-AMC: 69.1 %; 95 % CI -12.4 %, 12.1 % in the ITT population. The overall bacteriological success rates were similar in both treatment groups (MXF: 71.7 % versus PIP/TAZ-AMC: 71.8 %; 95 % CI -16.9 %, 10.7 %). A similar proportion of patients (ITT population) experienced any adverse events in both treatment groups (MXF: 30.9 % versus PIP/TAZ-AMC: 31.8 %, respectively). Death occurred in three MXF-treated patients and one PIP/TAZ-AMC-treated patient; these were unrelated to the study drugs.. Moxifloxacin has shown favorable safety and efficacy profiles in DFI patients and could be an alternative antibiotic therapy in the management of DFI.. NCT00402727.

Topics: Administration, Intravenous; Administration, Oral; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Aza Compounds; Bacteria; Bacterial Infections; Diabetic Foot; Female; Fluoroquinolones; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Moxifloxacin; Penicillanic Acid; Piperacillin; Quinolines; Tazobactam; Treatment Outcome

Bacterial infections causing acute exacerbations of chronic obstructive pulmonary disease (AECOPD) frequently require antibacterial treatment. More evidence is needed to guide antibiotic choice. The Moxifloxacin in Acute Exacerbations of Chronic Bronchitis TriaL (MAESTRAL) was a multiregional, randomised, double-blind non-inferiority outpatient study. Patients were aged ≥ 60 yrs, with an Anthonisen type I exacerbation, a forced expiratory volume in 1 s < 60% predicted and two or more exacerbations in the last year. Following stratification by steroid use patients received moxifloxacin 400 mg p.o. q.d. (5 days) or amoxicillin/clavulanic acid 875/125 mg p.o. b.i.d. (7 days). The primary end-point was clinical failure 8 weeks post-therapy in the per protocol population. Moxifloxacin was noninferior to amoxicillin/clavulanic acid at the primary end-point (111 (20.6%) out of 538, versus 114 (22.0%) out of 518, respectively; 95% CI -5.89-3.83%). In patients with confirmed bacterial AECOPD, moxifloxacin led to significantly lower clinical failure rates than amoxicillin/clavulanic acid (in the intent-to-treat with pathogens, 62 (19.0%) out of 327 versus 85 (25.4%) out of 335, respectively; p=0.016). Confirmed bacterial eradication at end of therapy was associated with higher clinical cure rates at 8 weeks post-therapy overall (p=0.0014) and for moxifloxacin (p=0.003). Patients treated with oral corticosteroids had more severe disease and higher failure rates. The MAESTRAL study showed that moxifloxacin was as effective as amoxicillin/clavulanic acid in the treatment of outpatients with AECOPD. Both therapies were well tolerated.

Topics: Aged; Aged, 80 and over; Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Aza Compounds; Bacterial Infections; Double-Blind Method; Female; Fluoroquinolones; Humans; Male; Middle Aged; Moxifloxacin; Prospective Studies; Pulmonary Disease, Chronic Obstructive; Quinolines; Treatment Outcome

The objective of this study was to identify the oral pathogens found in odontogenic infections, to determine their susceptibilities to amoxicillin-clavulanic acid (AMC), clindamycin (CLI), doxycycline (DOX), levofloxacin (LVX), moxifloxacin (MXF), and penicillin (PEN), and to search for associations between specific pathogens and types of infection. Swabs from patients enrolled in a randomized, double-blind phase II trial comparing MXF with CLI for the treatment of odontogenic abscesses or inflammatory infiltrates were cultured on media for aerobes and anaerobes. All bacterial isolates were identified at the species level. Overall, 205 isolates were cultured from 71 patients: 77 viridans group streptococci, 56 Prevotella spp., 19 Neisseria spp., 17 Streptococcus anginosus group isolates and hemolytic streptococci, 15 other anaerobes, and 21 other bacteria. Ninety-eight percent of pathogens were susceptible to MXF, 96% to AMC, 85% to LVX, 67% to PEN, 60% to CLI, and 50% to DOX. S. anginosus group and hemolytic streptococci were found significantly more frequently (P = 0.04) in patients with abscesses (12/95) than in patients with infiltrates (5/110). In four patients with infiltrates who failed to respond to CLI therapy, three isolates of the Streptococcus mitis group and four Neisseria spp. resistant to CLI were found. In this study, S. anginosus group and hemolytic streptococci were clearly associated with odontogenic abscesses. Our analysis suggests that viridans group streptococci and Neisseria spp. play a decisive role in the etiology of odontogenic infiltrates. The high in vitro activity of MXF against odontogenic bacteria corresponds well to its clinical results in the treatment of odontogenic abscesses and infiltrates.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Aza Compounds; Bacteria, Aerobic; Bacteria, Anaerobic; Bacterial Infections; Clindamycin; Culture Media; Double-Blind Method; Female; Fluoroquinolones; Germany; Humans; Male; Microbial Sensitivity Tests; Moxifloxacin; Outpatients; Penicillins; Periodontal Abscess; Prospective Studies; Quinolines

Acute sinusitis is a common upper respiratory tract infection worldwide, which can be severely complicated if inappropriate treatment is applied. The aim of this study was to assess and compare efficacy of cefuroxime and co-amoxiclav in the treatment of acute sinusitis in an Iranian sample population.. A randomized clinical trial, comparing the efficacy of two oral antibiotics, cefuroxime and co-amoxiclav in the treatment of acute sinusitis, was conducted in 2007. A total of 99 patients were enrolled in the study. The clinical diagnosis of acute sinusitis was based on association of suborbital pain, purulent rhinorrhea and purulent discharge on the middle nasal meatus. All patients were also radiographically examined and their diagnoses were confirmed. Patients were randomly assigned to either receive 10 days of treatment with cefuroxime 250 mg twice daily (n=57) or receive co-amoxiclav 500/125 mg three times daily (n=42). Patients responses to treatment were assessed during and at the end of the treatment.. A satisfactory clinical outcome (cure or improvement of symptoms) was found in 86% (49/57) and 71.4% (30/42) of the clinically evaluable patients treated with cefuroxime or co-amoxiclav, respectively (p >0.05).. The findings of this study suggest that cefuroxime (twice daily) is comparably effective as co-amoxiclav (three times a day) in the treatment of patients with acute sinusitis.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefuroxime; Child; Female; Humans; Iran; Male; Middle Aged; Single-Blind Method; Sinusitis; Young Adult

This prospective, randomized, open, international, multicenter study of adults with complicated intra-abdominal infections (cIAI) compared the efficacy and safety of sequential intravenous (i.v.) to oral (p.o.) moxifloxacin 400 mg once daily, with that of i.v. ceftriaxone 2 g once daily, plus metronidazole 500 mg three times daily, followed by p.o. amoxicillin/clavulanate 625 mg three times daily. The primary efficacy variable was clinical cure at test of cure (TOC) (day 28-42 after study entry) in the per protocol (PP) population. Of 595 patients in the study, 511 patients were valid for PP analysis (246 moxifloxacin, 265 ceftriaxone/metronidazole). Sequential moxifloxacin was noninferior to the comparator regimen--clinical cure rates at TOC were 80.9% versus 82.3% (moxifloxacin versus ceftriaxone/metronidazole; 95% CI -8.9, 4.2%). The incidence of adverse events was comparable between the two treatment groups. Therefore, sequential moxifloxacin monotherapy is as effective and safe as combination therapy with i.v. ceftriaxone plus i.v. metronidazole followed by oral amoxicillin/clavulanate for the treatment of cIAI.

Topics: Abdominal Abscess; Administration, Oral; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Appendicitis; Aza Compounds; Bacterial Infections; Ceftriaxone; Drug Therapy, Combination; Female; Fluoroquinolones; Gastrointestinal Diseases; Humans; Infusions, Intravenous; Intestinal Perforation; Male; Metronidazole; Microbial Sensitivity Tests; Middle Aged; Moxifloxacin; Peritonitis; Prospective Studies; Quinolines

A treatment containing a live food-grade organism, Lactococcus lactis DPC3147, was compared with conventional antibiotic therapy for its potential to treat bovine chronic subclinical or clinical mastitis in two separate field trials. Effects on disease symptoms and bacteriology were monitored in response to infusion with the culture in each trial. In the first trial, the live culture treatment was compared with an intramammary antibiotic (n=11 quarters for each treatment). Results from this small trial demonstrated that the live culture had potential to be as effective at eliminating chronic subclinical infections as an antibiotic treatment. By day 12, 7 of the 11 quarters treated with the live culture were pathogen-free compared with 5 of the 11 antibiotic-treated infected quarters. Somatic cell counts (SCC) remained relatively unchanged regardless of treatment: average log SCC pre- and post-treatment in the lactococci-treated group were 6.33+/-0.41 (day 0) and 6.27+/-0.43 cells/ml (day 12) and average log SCC pre- and post-treatment in the antibiotic-treated group were 6.34+/-0.37 and 6.22+/-0.46 cells/ml on day 0 and on day 12, respectively. In the second trial, the live culture was compared with an intramammary antibiotic for the treatment of naturally occurring clinical mastitis cases (n=25 quarters for each treatment). Following a 14-d experimental period, similar bacteriological responses were observed in 7 out of 25 live culture treated quarters and 9 out of 25 antibiotic-treated quarters. Additionally, 15 of 25 cases treated with the culture and 18 of 25 cases treated with the antibiotic did not exhibit clinical signs of the disease following treatment. The results of these trials suggest that live culture treatment with Lc. lactis DPC3147 may be as efficacious as common antibiotic treatments in some instances.

Topics: Amoxicillin-Potassium Clavulanate Combination; Animals; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Cattle; Female; Lactococcus lactis; Mammary Glands, Animal; Mastitis, Bovine; Milk; Treatment Outcome

The recommended treatment for acute bacterial rhinosinusitis in adults and children is 10 to 14 days of high doses of oral cephalosporins or amoxicillin/clavulanate.. This study compared the clinical efficacy and tolerability of cefditoren pivoxil and amoxicillin/clavulanate in children with uncomplicated acute bacterial rhinosinusitis.. This was a randomized, investigator-blinded, controlled study in pediatric patients (age 1-15 years) with clinical and radiographic signs and symptoms of acute rhinosinusitis. Patients were allocated to receive either cefditoren (8-12 mg/kg daily) or amoxicillin/clavulanate (80-90 mg/kg amoxicillin daily) for 14 days. Changes in sinus symptoms were assessed daily by patients or their parents using a quantitative symptom score (the S5 score). Rates of improvement, the primary efficacy measure, were also evaluated by the study investigators 7 and 14 days after the initial visit. Secondary outcome measures included time to improvement, adverse effects, and rates of relapse (assessed at days 21 and 28) and recurrence (assessed at day 60) of sinus symptoms. Relapse was defined as a subjective rating of lack of improvement at day 21 or 28 in a patient rated as improved on day 14, and recurrence was defined as sinus symptoms lasting for >or=10 days during the second month of follow-up in a patient rated as improved on day 28. Time to improvement was defined as the number of days between the initial visit and the time at which caregivers noted an improvement in patients' symptoms. Adverse events were monitored by parents/caregivers using a self-administered questionnaire and were also elicited by telephone contact.. The study enrolled 142 pediatric patients: 70 in the cefditoren group (42 males, 28 females; median age, 7.15 years) and 72 in the amoxicillin/clavulanate group (37 males, 35 females; median age, 6.60 years). Four patients in the cefditoren group were excluded from the study analyses (2 who were noncompliant [used <80% of the assigned medication] and 2 who developed infection at other sites). There were no significant differences in baseline medical history or signs and symptoms between the 2 groups. Rates of improvement at day 14 in the cefditoren and amoxicillin/clavulanate groups were 78.8% (52/66) and 84.7% (61/72), respectively (P = NS). There was no significant difference in the change in S5 scores between groups at day 14. The median time to improvement was 3.0 days in both groups. There were no significant differences between groups in rates of relapse (9.1% and 11.1%) or recurrence (3.0% and 5.6%) of sinus symptoms. The most common adverse event in both groups was diarrhea, occurring in 4.5% of the cefditoren group and 18.1 % of the amoxicillin/clavulanate group (P = 0.02).. In these children with acute bacterial rhinosinusitis, there were no significant differences between cefditoren and amoxicillin/clavulanate, the currently recommended treatment, in terms of rates of response, relapse, or recurrence.

Topics: Adolescent; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cephalosporins; Child; Child, Preschool; Female; Humans; Infant; Male; Recurrence; Rhinitis; Sinusitis

The present study was designed to evaluate the prophylactic efficacy after the correction of dentofacial deformities between short- and long-term penicillin and amoxicillin-clavulanic acid.. The present study was prospective, randomized, and double blinded. Patients were separated into four groups randomly: short-term and long-term (5 days) penicillin and short-term and long-term (5 days) amoxicillin-clavulanic acid.. One hundred twenty two patients were assigned randomly into the four groups. Infection developed in a patient in the short-term amoxicillin-clavulanic acid group and in a patient in the long-term penicillin group.. There were no differences in infection between the two groups of antibiotics. Based on the present study, short-term penicillin is still the most appropriate choice for prophylactic antibiotic in orthognathic surgery.

Topics: Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Bacterial Infections; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Osteotomy; Penicillins; Postoperative Complications; Preoperative Care; Prognathism; Prospective Studies; Temporomandibular Joint; Young Adult

To examine study entry microbiology in patients stratified by disease severity in a clinical trial in acute bacterial exacerbation of chronic bronchitis (ABECB).. Patients were assigned to differing antibiotic therapies based on stratification by disease severity using parameters including forced expiratory volume in 1 second (FEV(1)) as a percentage of predicted value, number of exacerbations during the previous 12 months, and defined co-morbidities. All patients were required to have sputum Gram stain and culture at study entry.. There was no statistically significant difference in overall microbiology between patients with less severe and more severe clinical presentations. Typical ABECB pathogens (Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis) were found in 46.2% (147/318) of patients with less severe presentations and 41.9% (143/341) of patients with more severe presentations. Gram-negative organisms and Staphylococcus aureus were also found in both groups. Pneumococcal susceptibilities to the three antibiotics utilized in the trial revealed marked resistance to azithromycin. Limitations of this analysis include that the clinical trial was designed to examine clinical outcomes rather than microbiology, and that we do not correlate study entry microbiology with clinical outcomes.. Stratification of patients by disease severity did not reveal a statistically significant difference in overall microbiological profile. Gram-negative organisms and S. aureus were recovered even from patients with less severe clinical presentations. Pneumococcal resistance varied with the agent tested. These findings may have implications for the selection of appropriate antibiotic therapy.

Topics: Acute Disease; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Bronchitis, Chronic; Double-Blind Method; Drug Resistance, Bacterial; Female; Forced Expiratory Volume; Humans; Male; Middle Aged; Ofloxacin; Severity of Illness Index; Sputum

The study was undertaken to characterize the microbiology of dental abscesses in children and to compare clindamycin and ampicillin/sulbactam in the treatment of facial cellulitis of odontogenic origin. Sixty children with acute facial cellulitis of dental origin underwent surgery (extraction or root canal procedure) within 24 hours of presentation. Pus samples were cultured aerobically and anaerobically. Patients were randomized (1:1) to receive intravenous ampicillin/sulbactam or clindamycin for 48 hours followed by oral amoxicillin/clavulanate or clindamycin for 7 days. A total of 211 bacterial isolates were recovered from 54 samples. The most common aerobic and facultative organisms were viridans streptococci, Neisseria, and Eikenella species. Among anaerobes, Prevotella and Peptostreptococcus species were the most frequent. No treatment failure occurred in either group. Dental abscesses in children are polymicrobial aerobic/anaerobic infections. Treatment of complicated dental infections with ampicillin plus a beta-lactamase inhibitor or clindamycin in combination with surgical drainage is very effective.

Topics: Adolescent; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Cellulitis; Child; Child, Preschool; Clindamycin; Face; Female; Humans; Male; Single-Blind Method; Sulbactam; Tooth Diseases

Complicated skin and skin structure infections (cSSSIs), including diabetic foot infections (DFIs), are often polymicrobial, requiring combination or broad-spectrum therapy. Moxifloxacin, a broad-spectrum fluoroquinolone, is approved for cSSSI and can be administered by either intravenous (iv) or oral routes. To assess the efficacy of moxifloxacin for treating DFIs, we analysed a subset of patients with these infections who were enrolled in a prospective, double-blind study that compared the efficacy of moxifloxacin with piperacillin-tazobactam and amoxicillin-clavulanate.. Patients>or=18 years of age with a DFI requiring initial iv therapy were randomized to either moxifloxacin (400 mg/day) or piperacillin-tazobactam (3.0/0.375 g every 6 h) for at least 3 days followed by moxifloxacin (400 mg/day orally) or amoxicillin-clavulanate (800 mg every 12 h orally), if appropriate, for 7-14 days. DFI was usually defined as any foot infection plus a history of diabetes. Our primary efficacy outcome was the clinical response of the infection at test-of-cure (TOC), 10-42 days post-therapy.. Among 617 patients enrolled in the original study, 78 with DFIs were evaluable for treatment efficacy. Clinical cure rates at TOC were similar for moxifloxacin and piperacillin-tazobactam/amoxicillin-clavulanate (68% versus 61%) for patients with investigator-defined infection (P=0.54). Overall pathogen eradication rates in the microbiologically-valid population were 69% versus 66% for moxifloxacin and comparator, respectively (P=1.00).. Intravenous+/-oral moxifloxacin was as effective as iv piperacillin-tazobactam+/-amoxicillin-clavulanate in treating moderate-to-severe DFIs. Moxifloxacin may have potential as a monotherapy regimen for DFIs.

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Aza Compounds; Bacterial Infections; Databases, Factual; Diabetic Foot; Double-Blind Method; Female; Fluoroquinolones; Humans; Male; Moxifloxacin; Penicillanic Acid; Piperacillin; Quinolines; Tazobactam

To determine the rate of prophylactic antibiotics usage in uncomplicated gynecologic abdominal surgery in Siriraj Hospital, before and after guideline implementation.. Two hundred and fifty-eight women who underwent elective gynecologic surgery for a benign condition were enrolled. The patients were divided into two groups, before and after guideline implementation (control and study group). Medical records of these women were reviewed to determine the rate of prophylactic antibiotics usage, rate of postoperative infection, and antibiotics cost.. The most common prophylactic antibiotics used were Cefazolin (41.9%), Cefoxitin (36.4%), and Augmentin (9.7%). Rate of single dose of cefazolin usage were not significantly different between the two groups (10.1% and 12.4% respectively, p = 0.482). However, the rate of postoperative oral antibiotic usage was significantly decreased (31.8% and 14.7% respectively, p = 0.001). The reduction of oral antibiotic usage was significant among staff only. The rate of postoperative infection between control and study groups, as well as between single and other antibiotic prophylaxis were similar. Had a single dose of cefazolin been administered to all patients, the antibiotics cost would have been reduced by 102,012 Baht or 91.8%.. Rate of a single dose of cefazolin usage as antibiotic prophylaxis in gynecologic surgery was similar to before guideline implementation. However, postoperative oral antibiotics usage decreased significantly, especially among the staff.

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Bacterial Infections; Cefazolin; Cefoxitin; Drug Utilization Review; Elective Surgical Procedures; Female; Gynecologic Surgical Procedures; Hospital Costs; Humans; Surgical Wound Infection; Thailand

To compare the safety and efficacy of sequential intravenous (IV) to oral (PO) moxifloxacin treatment against a standard antimicrobial regimen of IV piperacillin-tazobactam followed by PO amoxicillin-clavulanate for the treatment of adults with complicated intra-abdominal infection (cIAI).. cIAIs are commonly due to mixed aerobic and anaerobic bacteria and require both source control and broad-spectrum antibiotic therapy.. A prospective, double-blind, randomized, phase III comparative trial. Patients with cIAI were stratified by disease severity (APACHE II score) and randomized to either IV/PO moxifloxacin (400 mg q24 hours) or comparator (IV piperacillin-tazobactam [3.0/0.375 g q6 hours] +/- PO amoxicillin-clavulanate [800 mg/114 mg q12 hours]), each for 5 to 14 days. The primary efficacy variable was clinical cure rate at the test-of-cure visit (days 25-50). Bacteriologic outcomes were also determined.. : Of 656 intent-to-treat patients, 379 (58%) were valid to assess efficacy (183 moxifloxacin, 196 comparator). Demographic and baseline medical characteristics were similar between the 2 groups. Clinical cure rates at test-of-cure were 80% (146 of 183) for moxifloxacin versus 78% (153 of 196) for comparator (95% confidence interval, -7.4%, 9.3%). The clinical cure rate at test-of-cure for hospital-acquired cIAI was higher with moxifloxacin (82%, 22 of 27) versus comparator (55%, 17 of 31; P = 0.05); rates were similar for community-acquired infections (80% [124 of 156] versus 82% [136 of 165], respectively). Bacterial eradication rates were 78% (117 of 150) with moxifloxacin versus 77% (126 of 163) in the comparator group (95% confidence interval, -9.9%, 8.7%).. Once daily IV/PO moxifloxacin monotherapy was as least as effective as standard IV piperacillin-tazobactam/PO amoxicillin-clavulanate dosed multiple times daily for the treatment of cIAIs.

Topics: Abdominal Abscess; Administration, Oral; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Appendicitis; Aza Compounds; Bacterial Infections; Cross Infection; Double-Blind Method; Female; Fluoroquinolones; Gram-Negative Bacterial Infections; Gram-Positive Bacterial Infections; Humans; Injections, Intravenous; Intestinal Perforation; Male; Middle Aged; Moxifloxacin; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Prospective Studies; Quinolines; Safety; Stomach Rupture; Treatment Outcome

This post hoc analysis of data from a previous randomized, blinded, multicenter, parallel, noninferiority study assessed the bacterial etiology, symptom resolution, and tolerability of severe acute bacterial exacerbation of chronic bronchitis (ABECB) patients treated with either levofloxacin 750 mg QD for 5 days or amoxicillin/clavulanate 875 mg/125 mg BID for 10 days. Severe ABECB was defined as ABECB and forced expiratory volume in 1 second (FEV(1)) <50% of the predicted value, or (FEV(1)) of 50% to 65% of the predicted value plus comorbidities, or > or =4 exacerbations per year. A total of 369 patients were included in the intent-to-treat (ITT) population (187 treated with levofloxacin and 182 treated with amoxicillin/clavulanate), and 175 patients were microbiologically assessable (MA) (86 treated with levofloxacin and 89 treated with amoxicillin/clavulanate). In the ITT population, the mean age was 58.7 years, 49.1 % were male, and 48.2% were current smokers. At the on-treatment visit, a significantly higher proportion of MA patients in the levofloxacin group resolved purulent sputum production (57.5% vs 35.6%; P < 0.006), sputum production (65.4% vs 45.3%; P < 0.013), and cough (60.0% vs 44.0%; P < 0.045), compared with the amoxicillin/clavulanate group. However, no significant between-group differences were observed at posttreatment. A total of 341 pathogens were isolated, of which 143 (41.9%) were traditional ABECB flora, 181 (53.1%) were other gram-negative organisms, and 17 (5.0%) were gram-positive organisms. Overall susceptibility of the pathogens was 97.1% for levofloxacin and 90.6% for amoxicillin/clavulanate (P < 0.001). The prevalence of treatment-emergent adverse events was 42.1 % in patients who received levofloxacin and 48.6 % in those who received amoxicillin/clavulanate (95% CI,-4.0 to 17.0).

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis; Chronic Disease; Drug Administration Schedule; Female; Humans; Levofloxacin; Male; Ofloxacin

This randomized, controlled trial was designed to show that a short, 5-day course of pharmacokinetically enhanced amoxicillin-clavulanate at 2,000/125 mg (Augmentin XR) is as effective clinically as a longer, 7-day course of conventional amoxicillin-clavulanate at 875/125 mg (both given twice daily) in the treatment of acute exacerbations of chronic bronchitis (AECB). Amoxicillin-clavulanate at 2,000/125 mg was designed to extend the therapeutic levels of amoxicillin in serum over the 12-h dosing interval, compared with conventional formulations, to eradicate bacterial strains for which amoxicillin MICs were < or =4 microg/ml while retaining efficacy against beta-lactamase-producing pathogens. A total of 893 patients were randomized and received study medication (amoxicillin-clavulanate at 2,000/125 mg for 443 patients and 875/125 mg for 450 patients). Overall, 141 patients receiving amoxicillin-clavulanate at 2,000/125 mg and 135 receiving the comparator formulation had at least one pathogen identified at screening. Amoxicillin-clavulanate at 2,000/125 mg was as effective clinically in the per-protocol (PP) population at the test of cure (days 14 to 21, primary efficacy endpoint) as amoxicillin-clavulanate at 875/125 mg (clinical success rates of 93.0 and 91.2%, respectively; treatment difference, 1.8; 95% confidence interval [CI], -2.2, 5.7). Bacteriological success in the bacteriology PP population was high for both formulations (amoxicillin-clavulanate at 2,000/125 mg, 76.7%; amoxicillin-clavulanate at 875/125 mg, 73.0%; treatment difference, 3.8; 95% CI, -7.5, 15.0). Both therapies were well tolerated, with a similar incidence of adverse events. Fewer than 5% of patients in each group withdrew from the study due to adverse events. The shorter, 5-day course of amoxicillin-clavulanate at 2,000/125 mg was shown to be as effective clinically as a longer, 7-day course of amoxicillin-clavulanate at 875/125 mg, with high bacteriological efficacy and no difference in tolerability.

Topics: Acute Disease; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis, Chronic; Double-Blind Method; Female; Haemophilus influenzae; Haemophilus parainfluenzae; Humans; Male; Middle Aged; Moraxella catarrhalis; Streptococcus pneumoniae; Treatment Outcome

In this randomized, non-blinded study, the efficacy and safety of a 5-day course of moxifloxacin (one 400 mg tablet daily) was compared with that of co-amoxiclav (one 625 mg tablet every 8h) for 7 days, for the treatment of acute exacerbations of chronic bronchitis (AECB). A total of 162 patients with clear signs of an acute exacerbation of chronic bronchitis were enrolled. Of these, 153 could be studied. Seventy-nine patients were randomized in the moxifloxacin arm and 74 in the co-amoxiclav arm of the study. The primary efficacy parameter was clinical response at 14 days in the evaluable population. A clinical success was classified as resolution or improvement of symptoms. Variables used to assess clinical response included wheeze, cough, dyspnoea, sputum volume, rales and ronchi. The success rate in the moxifloxacin group was 88.6% (70 of 79) and that for co-amoxiclav group was 89.2% (66 of 74). At follow-up (28-35 days post-treatment), the continued clinical cure rates were 90.0% (63 of 70) for moxifloxacin and 89.4% (59 of 66) for co-amoxiclav. No significant differences were detected between the two groups. A total of 78 pathogenic bacteria were isolated from the sputum samples of the patients, with Moraxella catarrhalis, Haemophilus influenzae and Streptococcus pneumoniae being the most frequently isolated pathogens. The eradication rate at 14 days in the valid patients was similar for both groups, 90.9% (20 of 22) for the moxifloxacin group and 90.0% (18 of 20) for the co-amoxiclav group. Both drugs were well tolerated with no differences in the drug-related adverse effects or the patients withdrawing because of an adverse event. These results and the good spectrum of antibacterial activity make moxifloxacin a promising and also safe alternative for the empirical treatment of AECB.

Topics: Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Aza Compounds; Bacteria; Bacterial Infections; Bronchitis, Chronic; Drug Therapy, Combination; Female; Fluoroquinolones; Humans; Male; Middle Aged; Moxifloxacin; Quinolines; Sputum; Treatment Outcome

Intensive Care Unit (ICU) admission for acute exacerbation of chronic obstructive lung disease (COLD) is a major cause of morbidity and mortality in such patients. Although bacterial and/or viral infections are considered as the major precipitating factor, the antibiotic strategy in this setting is unclear. The potential benefit of routine antibiotic therapy in the absence of evidence of overt infection remains controversial, and has not been adequately studied in patients admitted to the ICU. To assess the benefit (or lack thereof) of routine early systemic antibiotic therapy in patients with COLD admitted to the ICU.. This is a multicenter, randomized, double-blind controlled trial, comparing amoxicillin-clavulanic acid administered for 7 days to a placebo. Patients included are those with documented or suspected COLD, exclusive of other bronchial or lung disease, and admitted for acute exacerbation, in the absence of overt sepsis or broncho-pneumonia, and having no other organ failure. Patients recently hospitalized, having received antibiotics for > 24 h, or on long-term steroids will not be included. Co-interventions (bronchodilators, steroids) are controlled for. Patients will be administered the antibiotic or placebo within 24 hours of admission.. A 20% reduction of the duration of clinical symptoms of exacerbation is expected. To this end, 520 patients are planned to be included in 15 centers in a 2-year period. Secondary end-points are the incidence of documented infection (lower respiratory tract or other sites), antibiotic use, the proportion of patients having infection with resistant bacteria, the incidence of endotracheal intubation, the duration of stay and mortality in the ICU and the hospital.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Critical Care; Double-Blind Method; Drug Administration Schedule; Drug Monitoring; Hospital Mortality; Humans; Incidence; Intubation, Intratracheal; Length of Stay; Morbidity; Multicenter Studies as Topic; Pulmonary Disease, Chronic Obstructive; Randomized Controlled Trials as Topic; Respiratory Tract Infections; Time Factors; Treatment Outcome

Antimicrobial therapy can have a significant impact in the treatment of acute infectious exacerbations in patients with chronic bronchitis, in whom repeated episodes are common. The aim of this randomised, double-blind, double-dummy, parallel group study was to compare the efficacy and safety of oral gatifloxacin (200 and 400 mg once daily) administered for 5 days with co-amoxiclav (500 mg amoxicillin/125 mg clavulanic acid t.i.d.) administered for 10 days in 414 adult patients with acute exacerbation of chronic bronchitis. Overall clinical response rates (cure plus improvement) were 86.2%, 79.4% and 81.7% in the gatifloxacin 200 mg, gatifloxacin 400 mg and co-amoxiclav groups, respectively, and the equivalence hypothesis used for statistical analysis showed equivalent efficacy for both gatifloxacin 200 and 400 mg compared to co-amoxiclav. The same was true for rates of bacterial response, with eradication or presumed eradication of causative pathogens achieved in 87.5%, 87.3% and 79.1% of cases in the gatifloxacin 200 mg, gatifloxacin 400 mg and co-amoxiclav groups, respectively. All treatments were well tolerated, with the nature and frequency of treatment-related adverse events similar in all groups. The results of the study show that gatifloxacin is a safe and effective agent for the treatment of patients with chronic bronchitis experiencing an acute infectious exacerbation.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bacteria; Bacterial Infections; Bronchitis, Chronic; Double-Blind Method; Drug Administration Schedule; Female; Fluoroquinolones; Gatifloxacin; Humans; Male; Partial Pressure; Treatment Outcome; Vital Capacity

In a randomized double-blind trial 251 adults with sinusitis-like symptoms were given amoxicillin/clavulanate or placebo for 6 days. Seven diagnostic indicators for acute bacterial rhinosinusitis are compared by their accuracy assuming a latent class model and by the treatment effect that they would have had if used to select a subset of patients for antibiotic treatment. Under a latent class model, radiography is a more efficient indicator then C reactive protein (CRP), which is, in turn, more efficient than other clinical signs and symptoms. However, a history of purulent nasal discharge, and signs of pus in the nasal cavity and throat, are better criteria than radiography or CRP for selecting those patients who will benefit from antibiotic treatment. These contradictory results are a salutary reminder that diagnostic indicators need to be evaluated in terms of therapeutic consequences for the patient.

Topics: Acute Disease; Adult; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Biomarkers; C-Reactive Protein; Double-Blind Method; Drug Therapy, Combination; Family Practice; Humans; Models, Statistical; Odds Ratio; Patient Selection; Rhinitis; Sinusitis; Treatment Outcome

Early transition from parenteral to oral antibiotic therapy switch therapy play a major role in treatment because of adverse reactions of long parenteral therapy. In the prospective, comparative and randomized clinical study the efficacy of two treatment regimens were analyzed: XICLAV (amoxicillin + clavulanic acid): parenteral regiment with early transition to oral therapy and parenteral regimen in patients with bacterial infections without transition to the oral dosage form, on the other hand. In our study we've analyzed 240 hospitalized patients in the Clinic of infectious Diseases in Tuzla and Sarajevo too, so in the Institution for infectious diseases in Zenica. The mean age of our patients was 39.6 years, 70.8% females. The major (50.5%) patients had urinary or respiratory tract infectious (bacterial pneumonia 38.8%) but several patients have had skin infections and sepsis. The first 120 patients were initially treated by Xiclav administered parenterally i.v. (adults at a dose of 3 x 1.2 gr i.v.; the children at a dose of 3 x 30 mg/kg) with early oral switch therapy (adults at a dose of 3 x 625 mg per os; the children at a dose of 3 x 25-50 mg/kg); whereas the others (120 patients) were treated parenterally by the regimen mentioned above. The mean length of i.v. therapy and hospitalization in the i.v. group was 4.12/10.21 days respectively (p > 0.05). The clinical efficacy switch of both therapeutic regimens was comparable. The resolution of all clinical symptoms and laboratory signs of infections was noted at 69% patients of both groups, with significant improvements at noted at 69% patients of both groups, with significant improvements at 21% patients and at 10% patients showed clinical failure. The tolerability of Xiclav was very good. The adverse reactions during treatment were observed at 5.2% patients. This study noticed satisfied clinical and bacterial efficacy so did tolerability of Xiclav in the treatment of bacteriological infections. Xiclav apply early transition from parenteral to oral therapy.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Infusions, Intravenous; Male; Middle Aged

Cefdinir is a new, extended-spectrum, orally active, third-generation cephalosporin that is resistant to bacterial beta-lactamase production. To evaluate efficacy and safety of the antibiotic in maxillary sinusitis, its use was compared with amoxicillin/clavulanate (amox/clav), which is a well-accepted beta-lactamase-resistant antibiotic. In this investigator-blinded multicenter phase III clinical study, 569 patients were randomly assigned to one of three treatment regimens: one daily dose of cefdinir 600 mg (OD), cefdinir 300 mg every 12 h (BD), and amox/clav 500/125 mg every 8 h. All antibiotics were administered orally for 10 days. Maxillary sinusitis was documented by typical clinical signs and symptoms and was confirmed by X-ray imaging. Before treatment, the genus and species of any pathogens were determined from sinus aspirates. Cultures were tested for beta-lactmase production and in vitro resistance to cefdinir and amox/clav. The effectiveness of antibiotic treatment was evaluated 7-14 days after therapy and whether or not recurrent clinical symptoms or persistent infection was determined 21-35 days post-therapy. The appearance of any adverse events was classified as associated or not associated with the medication of the study. Present findings showed that the in vitro susceptibility of pathogens to cefdinir and amox/clav was similar. Cefdinir OD or BD was therapeutically as effective as or better than amox/clav, although cefdinir BD was not as useful as amox/clav clinically. Cefdinir OD and BD and amox/clav were well tolerated. The statistical incidence of adverse events was the same among the three treatment groups, although cefdinir OD treatment had significantly fewer treatment discontinuations due to adverse events than BD and amox/clav.

Topics: Administration, Oral; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bacterial Infections; Cefdinir; Cephalosporins; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Humans; Male; Maxillary Sinusitis; Middle Aged; Treatment Outcome

To determine whether the use of prophylactic Augmentin in PPROM prolongs gestation and reduces neonatal and maternal morbidity due to sepsis.. Study setting was Harare Maternity Hospital, Zimbabwe. Women with PPROM between 26 and 36 weeks' gestation were randomly allocated either to a group given a course of prophylactic oral Augmentin or another receiving no prophylactic antibiotic treatment. The calculated sample size was 72 women per group. Data were analyzed using the EPI INFO program.. A total of 171 women were recruited into the study, 84 in the Augmentin group and 87 in the No Treatment group. The group receiving prophylactic Augmentin had a significantly longer latency period between rupture of membranes and delivery. There was a trend towards increased neonatal and maternal morbidity due to sepsis in the No Treatment group although no statistical significance was reached.. The use of prophylactic Augmentin in PPROM significantly prolongs gestation. It appears to decrease neonatal and maternal morbidity due to sepsis.

Topics: Administration, Oral; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Bacterial Infections; Female; Fetal Membranes, Premature Rupture; Gestational Age; Humans; Infant, Newborn; Pregnancy; Pregnancy Outcome; Pregnancy Trimester, Third; Reference Values; Treatment Outcome

Otitis media is a common infection of childhood. Increasing antibiotic resistance rates among the principal causative pathogens, Streptococcus pneumoniae and Haemophilus influenzae, are associated with failure of first line agents.. This open, randomized, multicenter study compared the clinical efficacy of a short 5-day course of cefuroxime axetil (CAE) suspension with that of amoxicillin/clavulanate (A/CA) suspension for 8 or 10 days.. Children age 6 to 36 months with acute otitis media with effusion, diagnosed by tympanocentesis and microbiologic culture, were randomized to receive CAE (30 mg/kg/day in two divided doses for 5 days) or A/CA 40 mg/kg/day in three divided doses for 10 days (A/CA-10). In French centers A/CA was given at 80 mg/kg/day in three divided doses for 8 days (A/CA-8). Patients were assessed 1 to 4 days after completing the course (posttreatment) and followed up at 21 to 28 days after completing the course.. Of the 716 patients randomized, 252 were treated with CAE, 255 with A/CA-10 and 209 with A/CA-8. In the clinically evaluable population, the proportions of patients with clinical cure at posttreatment were 175 of 203 (86%), 181 of 205 (88%) and 145 of 164 (88%) in the CAE, A/CA-10 and A/CA-8 groups, respectively, demonstrating equivalence among the three treatments. For patients <18 months old, clinical cures were 111 of 134 (83%), 116 of 131 (89%) and 83 of 99 (84%) in the CAE, A/CA-10 and A/CA-8 groups, respectively; equivalence was also demonstrated. At follow-up, 130 of 175 (74%) CAE, 121 of 172 (70%) A/CA-10, and 112 of 142 (79%) A/CA-8 had maintained cure. A total of 837 pretreatment pathogens were isolated from middle ear fluid in 73% (522 of 716) patients, the majority of isolates were S. pneumoniae (30%) and H. influenzae (27%). The most common adverse events were gastrointestinal, the incidence of drug-related diarrhea being higher in the A/CA-10 group (18%) than in either the CAE or A/CA-8 groups (10%).. A 5-day course of CAE, given twice daily, was shown to be equivalent to the two regimens of A/CA for treatment of acute otitis media with effusion in children.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefuroxime; Cephalosporins; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media with Effusion; Treatment Outcome

A randomized study of a 3-day course of azithromycin therapy (500 mg once daily) vs. a 10-day course of co-amoxiclav therapy (625 mg thrice daily) in patients with acute sinusitis was performed with an account of the GCP criteria. One hundred patients in 2 groups each of 50 persons were enrolled. The estimates of the patient body temperature, headache, pain on palpation in the area of the accessory nasal sinuses, nasal cavity stuffing, nasal discharge nature and the nose mucous membrane appearance were recorded prior to the treatment, in 72 hours and on the 10th-12th and 26th-30th days of the treatment. The microbiological analysis of the punctate from the accessory nasal sinuses was undertaken before the antibiotic therapy and 72 hours after its start. The economic analysis included the cost of the antibiotic therapy course, hospitalization term, medical manipulations and laboratory tests as well as the cost/efficacy index. The frequency of the relapses within 6 months after the cure was estimated in the two groups compared. In 72 hours and on the 10th-12th days after the treatment start the efficacy of azithromycin was significantly higher than that of co-amoxiclav. The cure was stated in 41 (82 per cent) and 26 (52 per cent) patients on the 10th-12th days, in 6 (12 per cent) and 21 (42 per cent) patients the improvement was stated and the fail was stated in 3 (6 per cent) and 2 (4 per cent) patients respectively. The efficacy of the drugs on the 26th-30th days after the treatment start did not differ. The isolates of Staphylococcus aureus and Streptococcus pyogenes were the main pathogens. The bacteriologic eradication was recorded in 29 (90.6 per cent) patients treated with azithromycin and only in 18 (69.2 per cent) patients treated with co-amoxiclav. Adverse reactions and relapses of the disease within 6 months after the cure were more frequent in the patients treated with co-amoxiclav. The cost of the azithromycin therapy was significantly lower. It was shown that the shortened course of the azithromycin therapy provided earlier cure of the patients with acute sinusitis, better tolerance of the drug, less frequent adverse reactions, lower cost as compared to the use of co-amoxiclav and no relapses.

Topics: Acute Disease; Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bacteria; Bacterial Infections; Costs and Cost Analysis; Drug Therapy, Combination; Female; Humans; Male; Sinusitis; Time Factors

Cefaclor and amoxycillin/clavulanate are active against Haemophilus influenzae, Streptococcus pneumoniae, Moraxella catarrhalis and Staphylococcus aureus--pathogens commonly associated with acute exacerbations of chronic bronchitis (AECB). This randomised, parallel-group, single-blind, multicentre study investigated the comparative efficacy and safety of 7-day treatment regimens of cefaclor AF (750 mg b.d. [n = 73]) and amoxycillin/clavulanate (875/125 mg b.d. [n = 72]) in AECB. A favourable clinical response was obtained in 95.9% of patients on cefaclor AF and 97.2% of patients on amoxycillin/clavulanate. There were no statistically significant differences between the groups for improvement in clinical response measured by pulmonary peak expiratory flow (PPEF), or for common symptoms associated with AECB. Both agents were well tolerated, with no statistically significant differences in overall safety; however, nausea and vomiting, and abdominal pain, the most frequently occurring adverse events in the amoxycillin/clavulanate group, were not reported in the cefaclor group. In conclusion, cefaclor AF and amoxycillin/clavulanate have similar efficacy and safety profiles in the treatment of AECB.

Topics: Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis; Cefaclor; Cephalosporins; Chronic Disease; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Peak Expiratory Flow Rate; Single-Blind Method

To compare in a randomized prospective study the infective complication rates of a single intravenous dose of co-amoxiclav given alone before transrectal prostatic biopsy with an intravenous dose followed by oral co-amoxiclav for 24 h.. Eighty-three patients undergoing prostatic biopsy were randomized to receive 1.2 g co-amoxiclav intravenously and then either three further doses of oral co-amoxiclav (Group 1) or no further antibiotics (Group 2). The evaluation included analysis of a mid-stream urine (MSU) sample before and 72 h after biopsy, and the recording of oral temperatures and symptoms in the first 44 patients. Patients with symptomatic urinary tract infections (UTIs), prostatitis, indwelling catheters, diabetes and those receiving steroid therapy were excluded.. Eight patients, four from each treatment arm, were found to have asymptomatic UTIs from their MSU before biopsy. Excluding these patients, four patients (11%) from Group 1 and six from Group 2 (16%) had positive MSUs at 72 h; two patients from Group 2 and one from Group 1 required admission to hospital. Of the patients returning symptom and temperature charts, a further six (14%; three from each group) reported signs and symptoms suggestive of infection despite negative urine cultures.. There was no statistically significant difference in the rate of positive MSUs between the groups. The incidence of infections was considerably higher than in previously published series where other antibiotics were used, suggesting that co-amoxiclav is not the drug of choice for transrectal prostatic biopsy.

Topics: Administration, Oral; Aged; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Biopsy, Needle; Drug Therapy, Combination; Humans; Infusions, Intravenous; Male; Prospective Studies; Prostatic Diseases; Treatment Failure

Acute otitis media (AOM) in children with tympanostomy tubes in place typically presents with otorrhea (draining ear). Because therapy is not standardized, various topical and systemic antibiotics of unproven efficacy and safety have been used in this indication. This study compared the safety and efficacy of ofloxacin otic solution, 0.3% (OFLX) with that of Augmentin oral suspension (AUG) in pediatric subjects 1-12 years of age with tympanostomy tubes and acute purulent otorrhea. Subjects were randomized to receive 10d of OFLX, 0.25 ml topically bid, or of AUG, 40 mg/kg per day. Audiometry was performed in subjects > or =4 years of age. Overall cure rate for clinically evaluable subjects was 76% with OFLX (n = 140) and 69% with AUG (n = 146; P = 0.169). Overall eradication rates for OFLX and AUG were similar for Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis and were superior with OFLX for Staphylococcus aureus and Pseudomonas aeruginosa (P<0.05 for both). OFLX had a greater overall pathogen eradication rate (96% vs. 67%; P<0.001). Treatment-related adverse event rates were 31% for AUG and 6% for OFLX (P<0.001). Neither treatment significantly altered hearing acuity. Topical ofloxacin 0.3% otic solution 0.25 ml bid was as effective and better tolerated than systemic therapy with Augmentin oral suspension 40 mg/kg per day in treating AOM in children with tympanostomy tubes.

Topics: Acute Disease; Administration, Oral; Administration, Topical; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Audiometry; Bacterial Infections; Child, Preschool; Drug Therapy, Combination; Female; Humans; Male; Middle Ear Ventilation; Ofloxacin; Otitis Media, Suppurative

Cefdinir is an extended-spectrum oral cephalosporin that is active against pathogens commonly seen in acute community-acquired bacterial sinusitis (ACABS), including Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. Two randomized, investigator-blind, multicenter trials (one in the United States and one in Europe) compared two dosage regimens of cefdinir (600 mg once a day for 10 days and 300 mg twice a day for 10 days) to amoxicillin-clavulanate (A-C) (500 mg three times a day for 10 days) for adult and adolescent patients with ACABS. Twelve hundred twenty-nine patients entered the U.S. study, 698 with antral puncture; 569 patients entered the European study, all with antral puncture. Clinical response (cure or improvement) was determined 7 to 14 days and 3 to 5 weeks posttherapy. Microbiologic eradication rates were determined 10 to 30 days posttherapy in a subset of patients who underwent pre- and posttherapy sinus aspirate culture. Rates of adverse events and treatment discontinuations due to adverse events were examined. Cefdinir, given once or twice daily, was as effective clinically (approximately 90% cure rate) as amoxicillin-clavulanate given three times daily in the treatment of ACABS. Microbiologic eradication rates were also similar in the three groups. The major side effect was mild diarrhea, occurring in approximately 20% of each group. Cefdinir caused fewer adverse events requiring treatment discontinuation.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefdinir; Cephalosporins; Child; Clavulanic Acids; Community-Acquired Infections; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Single-Blind Method; Sinusitis; Treatment Outcome

Topics: Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Bacterial Infections; Ciprofloxacin; Critical Care; Dose-Response Relationship, Drug; Drug Administration Schedule; Gastrointestinal Hemorrhage; Humans; Infusions, Intravenous; Liver Cirrhosis; Opportunistic Infections; Risk Factors; Survival Rate

Infections are still the most frequent postoperative complications and one of the limiting factors of successful gynaecological surgery. In recent years information on successful anti-microbial chemoprophylaxis is increasing and is associated with reduced postoperative inflammations, febrile morbidity and early complications. Views differ above all as regards indications for the use of antibiotic prophylaxis and the selection of a suitable antibiotic. Data in the literature differ also as regards achieved results. The submitted work had the objective to test on a representative group the success and rationality of medicamentous prophylaxis in gynaecological surgery and to contribute to a clearer view on controversial points. 203 women admitted to the Second Gynaecological and Obstetric Department of the First Medical Faculty Charles University and General Faculty Hospital Prague for elective abdominal or vaginal hysterectomy on account of a benign indication were divided into three groups which did not differ from the demographic or medical aspect. In group A (53 women) for prophylaxis two doses of Augmentin were used (combination of amoxycillin with clavulanic acid) i.v., patients in group M (50 women) had three doses of Mandol (Cefamandol) i.m., and in control group K (100 patients) no antibiotics were administered prophylactically. The authors investigated the postoperative course and evaluated some parameters in relation to possible postoperative infectious complications. The results proved unequivocally that prophylaxis with Augmentin reduces significantly the postoperative infectious morbidity (11.5%), febrile morbidity (5.6%) and the incidence of early infectious complications (3.8%) after abdominal or vaginal hysterectomy, as compared with the control group (35%, 31% and 11% resp.). Prophylaxis with Cefamandol reduced only in few parameters postoperative complications, but in general did not lead to a significant improvement of the postoperative course nor to a reduction of postoperative inflammatory complications. Similar results were obtained when only complications after abdominal hysterectomy were evaluated. The results of bacteriological examination confirmed the expected differences in the spectrum of efficacy of the two antibiotics on the most common microbial flora in the given area, i.e. a high sensitivity of Augmention to enterococci and bacterioids and resistance of these bacteria to Mandol. These results can be considered one of the re

Topics: Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Bacterial Infections; Cefamandole; Cephalosporins; Drug Therapy, Combination; Female; Humans; Hysterectomy; Middle Aged; Postoperative Complications

Upper-respiratory-tract infection is one of the main causes of overuse of antibiotics. We have found previously that bacteria such as Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae can be isolated from the nasopharyngeal secretions of a substantial proportion of adults with upper-respiratory-tract infections. We have assessed the efficacy of co-amoxiclav in patients with common colds but no clinical signs of sinusitis or other indications for antibiotics.. Between January, 1992 and March, 1994, 314 patients who presented to our outpatient clinic with common colds were enrolled in the double-blind, placebo-controlled study. They were randomly assigned 5 days' treatment with co-amoxiclav (375 mg three times daily) or identical placebo. Clinical examinations were done at enrolment and on day 5-7 to assess outcome (cured, persistent symptoms, worse symptoms). Seven patients were excluded after randomisation, seven did not have nasopharyngeal aspiration, and 12 did not return for followup assessment.. Of 300 patients with nasopharyngeal aspirates, 72 had negative bacterial cultures, 167 had cultures positive only for bacteria unrelated to respiratory infections, and 61 had cultures positive for H influenzae, M catarrhalis, or S pneumoniae. At 5-day follow-up of these culture-positive patients, the distribution of outcome was significantly better among co-amoxiclav-treated (n=30) than placebo-treated (n=28) patients (cured 27 vs 4%; persistent symptoms 70 vs 60%; worse symptoms 3 vs 36%; p=0.001). Patients on co-amoxiclav also scored their symptoms significantly lower than patients on placebo (p=0.008). Among culture-negative patients (n=230), the outcome distribution did not differ between the treatment groups (p=0.392).. The majority of patients with upper-respiratory-tract infection do not benefit from antibiotics and side-effects are frequent. However, for the subgroup whose nasopharyngeal secretions contain H influenzae, M catarrhalis, or S pneumoniae, antibiotics are clinically beneficial.

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Common Cold; Double-Blind Method; Drug Therapy, Combination; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Moraxella catarrhalis; Nasopharynx; Neisseriaceae Infections; Pneumococcal Infections; Treatment Outcome

An open randomized trial was conducted in 142 hospitalized and out-patients with acute purulent exacerbation of chronic bronchitis to compare the clinical efficacy and tolerability of azithromycin (n = 69) and amoxicillin/clavulanic acid (n = 73). Azithromycin (500 mg) was administered as a single dose for three days and amoxicillin/clavulanic acid (amoxicillin 875 mg-clavulanic acid 125 mg) was given b.i.d. for 8 days (8.16 +/- 1.18). Before therapy and 24-48 hours after the end of treatment, sputum culture (by positioning five orthodontal swabs at the opening of salivary gland ducts after a washing of the oral cavity with sterile saline solution to avoid oral contamination), chest X-rays, arterial blood gas analysis, trials of respiratory functions and routine blood tests were performed. In the azithromycin group (69 patients) the efficacy rate was 67.6% (46 patients: 34 cured and 12 improved); in 22 patients (32.4%) the treatment failed; 1 patient was not evaluated because of no follow-up. The overall efficacy rate in the amoxicillin/clavulanic acid group (73 patients) was 97.3% (71 patients: 60 cured and 11 improved); in 1 patient (1.4%) the treatment failed and 1 patient was a drop-out for side effects. All pathogens isolated before treatment were susceptible to the antibiotics administered. At the end of treatment microbiological efficacy was 67.1% in the azithromycin group and 98.6% in the amoxicillin/clavulanic acid group. The tolerability was judged good in both treatment groups. Side effects were observed in 1 patient treated with amoxicillin/clavulanic acid (diarrhea), which imposed interruption of treatment, and in 2 patients from the azithromycin group (gastralgia and biochemical laboratory tests: renal function).(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Azithromycin; Bacterial Infections; Bronchitis; Chronic Disease; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Sputum

The purpose of the present investigation was to assess the effects of periodontal surgery and 4 systemically administered agents, Augmentin, tetracycline, ibuprofen or a placebo on clinical and microbiological parameters of periodontal disease. 98 subjects were monitored at 2-month intervals at 6 sites per tooth for clinical parameters. Subgingival plaque samples were taken from the mesial surface of each tooth at each visit and evaluated for their content of 14 subgingival species using DNA probes and a colony lift method. 40 subjects who exhibited loss of attachment > 2.5 mm at 1 or more sites during longitudinal monitoring were treated using modified Widman flap surgery at sites with probing pocket depth > 4 mm, subgingival scaling at all other sites and were randomly assigned 1 of the 4 agents. Treatment was completed within 30 days during which time the subject took the assigned agent. Overall, subjects exhibited a mean attachment level "gain" of 0.34 +/- 0.10 mm (SEM) and a mean pocket depth reduction of 0.62 +/- 0.09 mm 10 +/- 4 months post-therapy. However, certain subjects in each treatment group showed a poor response. Subjects receiving antibiotics exhibited significantly more attachment level "gain" (0.57 +/- 0.15 mm, SEM) than subjects receiving either ibuprofen or a placebo (0.02 +/- 0.10). The differences between Augmentin and tetracycline groups were not significant, nor were the differences between ibuprofen and placebo. 10 months post-therapy, there was a reduction in the number of sites colonized in any subject group by detectable levels (10(3)) of P. gingivalis. Species showing similar reductions were B. forsythus, P. intermedia and P. micros. Subjects receiving systemically administered antibiotics had a significant increase in the proportion of sites colonized by C. ochracea coupled with a greater decrease in the number of sites colonized by P. gingivalis, B. forsythus, P. intermedia and P. micros post-therapy than subjects not receiving antibiotics. The results of this investigation indicate that adjunctive systemic antibiotics increase periodontal attachment "gain" and decrease the levels of some suspected periodontal pathogens in subjects with evidence of current disease progression.

Topics: Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Bacterial Infections; Bacteroidaceae; Chemotherapy, Adjuvant; Clavulanic Acids; Dental Plaque; Dental Scaling; Disease Progression; Drug Therapy, Combination; Female; Humans; Ibuprofen; Longitudinal Studies; Male; Middle Aged; Periodontal Attachment Loss; Periodontal Pocket; Placebos; Subgingival Curettage; Surgical Flaps; Tetracycline

Five hundred thirty-seven patients were enrolled in two independent, investigator-blinded, multicenter, randomized clinical trials comparing the clinical and bacteriologic efficacies and the safety of 5- or 10-day treatment with cefuroxime axetil with those of 10-day treatment with amoxicillin-clavulanate in the treatment of secondary bacterial infections of acute bronchitis. Patients received either 5 or 10 days of treatment (n = 177 in each group) with cefuroxime axetil at 250 mg twice daily or 10 days of treatment (n = 183) with amoxicillin-clavulanate at 500 mg three times daily. Patients in the cefuroxime axetil (5 days) group received placebo on days 6 to 10. Bacteriologic assessments were based on sputum specimen cultures obtained preceding and, when possible, following treatment. Organisms were isolated from the pretreatment sputum specimens of 242 of 537 (45%) patients, with the primary pathogens being Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, and Staphylococcus aureus (28, 25, 13, 9, and 8% of isolates, respectively). Pathogens were eradicated or presumed to be eradicated in 87% (52 of 60), 91% (53 of 58), and 86% (60 of 70) of bacteriologically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. A satisfactory clinical outcome (cure or improvement) was achieved in 82% (107 of 130), 86% (117 of 136), and 83% (130 of 157) of the clinically evaluable patients treated with cefuroxime axetil (5 days), cefuroxime axetil (10 days), and amoxicillin-clavulanate, respectively. Treatment with amoxicillin-clavulanate was associated with a significantly higher incidence of drug-related adverse events than was treatment with cefuroxime axetil for either 5 or 10 days (P = 0.001), primarily reflecting a higher incidence of drug-related gastrointestinal adverse events (37 versus 19 and 15%, respectively; P < 0.001), particularly diarrhea and nausea. These results indicate that treatment with cefuroxime axetil at 250 mg twice daily for 5 days is as effective as treatment for 10 days with either the same dose of cefuroxime axetil or amoxicillin-clavulanate at 500 mg three times daily in patients with acute bronchitis. In addition, treatment with cefuroxime axetil for either 5 or 10 days is associated with significantly fewer gastrointestinal adverse events, particularly diarrhea and nausea, than is 10-day treatment with amoxic

Topics: Acute Disease; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Bronchitis; Cefuroxime; Cephalosporins; Child; Clavulanic Acids; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Treatment Outcome

The efficacy and tolerability of ciprofloxacin (500 mg twice daily) was compared with that of amoxycillin/clavulanic acid (500 mg three times daily) in 76 patients with acute exacerbations of chronic non-cholesteatomatous suppurative otitis media enrolled in this open randomized multicentre trial. A total of 40 ciprofloxacin-treated patients and 35 amoxycillin/clavulanic acid-treated patients were evaluable for clinical efficacy following the 9-day treatment period. Pseudomonas aeruginosa was the main pathogen isolated prior to treatment. At the end of treatment, otorrhoea had disappeared in 57.5% of the ciprofloxacin group and 37.1% of the amoxycillin/clavulanic acid group (p = 0.04). Bacterial eradication rate was also significantly greater with ciprofloxacin (69.7%) than with amoxycillin/clavulanic acid (27.3%). Both treatments were well tolerated. Ciprofloxacin appears to be an effective treatment of chronic otitis media, and superior to amoxycillin/clavulanic acid.

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Chronic Disease; Ciprofloxacin; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Otitis Media, Suppurative; Pseudomonas Infections; Time Factors

A total of 251 adults with chronic sinusitis were enrolled into this prospective multicentre, double-blind, double-placebo comparison of ciprofloxacin (500 mg twice daily) with amoxycillin/clavulanic acid (500 mg three times daily). The diagnosis of chronic sinusitis (persistence of clinical symptoms for at least 3 months) was confirmed by computerized tomography scan and/or sinusoscopy prior to therapy. Patients at inclusion had purulent or muco-purulent rhinorrhoea. Staphylococcus aureus (n = 45), Haemophilus influenzae (n = 35), Streptococcus pneumoniae (n = 32) and enterobacteriaceae (n = 31) were isolated from pre-treatment aspirates of the middle meatus. Treatment lasted 9 days, at the end of which nasal discharge disappeared in 71/118 (60.2%) patients of the ciprofloxacin group and 69/123 (56.1%) of those in the amoxycillin/clavulanic acid group. The clinical cure and bacteriological eradication rates were 58.6% versus 51.2% and 88.9% versus 90.5% for ciprofloxacin and amoxycillin/clavulanic acid, respectively. These differences were not significant, however, amongst patients who had a positive initial culture and who were evaluated 40 days after treatment. Ciprofloxacin recipients had a significantly higher cure rate than those treated with amoxycillin/clavulanic acid (83.3% vs. 67.6%, p = 0.043). Clinical tolerance was significantly better with ciprofloxacin (p = 0.012), essentially due to a large number of gastro-intestinal related side-effects in the amoxycillin/clavulanic acid group (n = 35). Ciprofloxacin proved to be at least as effective as amoxycillin/clavulanic acid. The superior safety profile, a twice daily dosage regimen, suggests that ciprofloxacin may be a useful therapeutic alternative for the treatment of chronic sinusitis.

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Chronic Disease; Ciprofloxacin; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Ethmoid Sinusitis; Female; Frontal Sinusitis; Humans; Male; Maxillary Sinusitis; Middle Aged; Prospective Studies; Sinusitis

Cefprozil was evaluated in four multicentre comparative studies in the treatment of acute respiratory tract infections. In two studies, cefprozil 500 mg q. 12 hours was compared to cefaclor 500 mg q. eight hours for ten days of therapy. Randomization was on a 2:1 (cefprozil:cefaclor) basis in the European centres and 1:1 in North America. The clinical efficacy in acute bronchitis was 88% (284 out of 324 patients) for cefprozil and 88% (183 out of 208) for cefaclor, with successful bacteriological eradication of the causative pathogen in 86% and 82% of the patients, respectively. Amongst the patients with acute exacerbations of chronic bronchitis, the clinical response rate of 80% (59 out of 74) for cefprozil appeared superior to that of cefaclor at 62% (p = 0.067), whilst the bacteriological response rates were 62% (36 out of 58) for cefprozil and 74% (20 out of 27) for cefaclor. In pneumonia, the clinical response rates for cefprozil and cefaclor therapy were similar, 82% vs. 79%, although bacteriological eradication rates were better for cefprozil at 82% than for cefaclor at 71%. In the comparison of cefprozil with cefuroxime axetil, a total of 170 patients were evaluable. The clinical and bacteriological response rates for cefprozil of 95% and 100% were better than those for cefuroxime axetil 500 mg q. 12 hours of 84% and 75%, respectively. In the cefprozil vs. amoxicillin-clavulanate, 500 mg q. eight hours comparative study, the two antibiotics displayed no significant difference in clinical or bacteriological responses.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bronchitis; Cefaclor; Cefprozil; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Multicenter Studies as Topic; Pneumonia; Prodrugs; Randomized Controlled Trials as Topic; Respiratory Tract Infections

Cefprozil was evaluated in the treatment of acute otitis media with effusion in three open, randomized, multicenter comparative clinical trials. In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens. The treatment groups were comparable in demographic characteristics, and presented with otalgia, middle-ear effusion, or inflamed or bulging tympanic membrane on otoscopic examination. In all patients, tympanocentesis and a culture were required. Two cefprozil oral doses were evaluated, 30 mg/kg/day and 40 mg/kg/day divided into two equal doses (b.i.d.). Amoxicillin-clavulanate was administered at 40 mg/kg/day in three divided doses (t.i.d.). The recommended duration of therapy was ten days. The predominant bacteria isolated were Haemophilus influenzae and Moraxella catarrhalis. The overall satisfactory clinical response rates were similar for cefprozil (83%) and amoxicillin-clavulanate (81%). The bacteriological response rates did not differ significantly, at 84% and 82%. Cefprozil eradicated the most common pathogen, Streptococcus pneumoniae, more often at 91%, vs. 84% for amoxicillin-clavulanate. The eradication rates were similar against Haemophilus influenzae and Moraxella catarrhalis. The patients treated with cefprozil had a lower rate of adverse clinical events (11%) compared to those with amoxicillin-clavulanate (20%). More gastrointestinal adverse experiences, including diarrhea, were reported in the amoxicillin-clavulanate-treated patients. In Study 3, cefprozil 30 mg/kg/day (b.i.d.) was compared to cefaclor 40 mg/kg/day (t.i.d.) and cefixime 8 mg/kg/day (q.d) in the treatment of acute otitis media in 388 pediatric patients. The patients were treated for 10 days, with a follow-up of 18 days. The overall clinical cure rates were 85%, 89% and 85%, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cefixime; Cefotaxime; Cefprozil; Cephalosporins; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant; Male; Microbial Sensitivity Tests; Multicenter Studies as Topic; Otitis Media; Randomized Controlled Trials as Topic

A new macrolide drug, clarithromycin (Biaxin) was compared with amoxicillin/clavulanate (Augmentin) in a single-blind (investigator-blind), randomized, multicenter study of 497 outpatients with acute maxillary sinusitis; treatment was 500 mg clarithromycin bid (n = 246) or 500 mg amoxicillin/clavulanate tid (n = 251). Pathogens included Streptococcus pneumoniae in 22% of patients, Staphylococcus aureus in 16%, Haemophilus influenzae in 10%, and Moraxella catarrhalis in 7%. For evaluable patients, clinical success (cure or improvement) was noted for 97% (128/132) of clarithromycin recipients and 93% (119/128) amoxicillin/clavulanate recipients. Clinically significant improvement in signs and symptoms was comparable between groups. Bacteriologic cure rates were 87% (115/132) and 90% (115/128), respectively. Respective pathogen eradication rates were 87% (125/143) and 90% (125/139). Adverse events not due to concurrent conditions occurred in 41% of the former and 46% of the latter group; most were mild to moderate gastrointestinal upsets (21% and 38%, respectively; P < 0.001). We conclude that clarithromycin appears to be as effective as amoxicillin/clavulanate in acute maxillary sinusitis and may cause fewer gastrointestinal upsets.

Topics: Acute Disease; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Analysis of Variance; Bacterial Infections; Clarithromycin; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Maxillary Sinusitis; Single-Blind Method; Treatment Outcome

Mucogingival flaps were reflected over pairs of mandibular molar teeth with Class II furcation invasions. The dimensions of the furcations were measured. The teeth were debrided and an expanded polytetrafluoroethylene (e-PTFE) membrane was placed and retained over one furcation of each pair (test site) for 4 weeks. The second site served as a control. Eight patients (group 1) with 12 e-PTFE sites received no antibiotic. Seven patients (group 2) with 12 e-PTFE sites were administered amoxicillin/clavulanate potassium for 10 days. Paper-points were used to collect bacterial samples and clinical indices were recorded at baseline and weekly for 4 weeks. Paper-point samples and the e-PTFE collected at week 4 were sonicated and analyzed by DNA probes for seven putative pathogens. At baseline no parameter showed statistical differences between groups or sites. At week 1 significantly greater levels of Prevotella intermedia type I (P < 0.05) and Fusobacterium nucleatum (P < 0.01) were found in group 1. At week 4, paper-point samples from test sites (P < 0.05) and e-PTFE materials (P < 0.001) showed significantly higher presence of Bacteroides forsythus in group 1. No significant microbial changes were found for control sites over time or between groups. The total bacterial load at test sites over time increased similarly for patients administered or not administered the antibiotic. Clinical signs of inflammation were significantly greater in group 1 and associated with the presence of B. forsythus (P < 0.01).

Topics: Adult; Aged; Alveolar Bone Loss; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Bacteroides; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Eikenella corrodens; Female; Fusobacterium nucleatum; Guided Tissue Regeneration, Periodontal; Humans; Male; Middle Aged; Periodontal Diseases; Polytetrafluoroethylene; Surgical Flaps; Tooth Root

A prospective, randomized, open study was performed in 199 patients at the Leyenburg Hospital comparing amoxycillin/clavulanate (AMX/CL) with cefuroxime plus metronidazole (CR/MN) in the prophylaxis of infection following gynaecological surgery. AMX/CL was given as a single dose of 2200 mg i.v. at the start of the operation. CR/MN, 750/500 mg i.v. was administered 3 times within 24 h, beginning at the start of the operation. The study group consisted of patients undergoing either a vaginal hysterectomy, a vaginal hysterectomy with cysto/rectocele repair or a secondary caesarean section. There were no statistically significant differences in demographic characteristics, duration of surgery or anaesthetic method between the two groups. Postoperatively, 10.6% of patients developed a urinary tract infection, and febrile temperatures were found in 9.0% of patients. There were no statistically significant differences between the two treatment groups. Other complications were found in less than 1% of the study population, equally distributed between the two regimens. In this study there was a low overall percentage of infection after gynaecological surgery. AMX/CL was as effective as CR/MN as a perioperative prophylactic treatment and has the dual advantage of a single dose and lower cost.

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefuroxime; Cesarean Section; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Hysterectomy; Intraoperative Complications; Metronidazole; Middle Aged; Postoperative Complications; Pregnancy; Prospective Studies

The efficacy and safety of a once-a-day antibiotic in the treatment of sinusitis was studied. Two randomly assigned groups were treated with either once-a-day cefixime, a third generation cephalosporin, or amoxicillin three times a day. One hundred and fourteen patients were evaluated with antral punctures, microbiologic evaluation, and radiographic studies. Cultures revealed 40% gram-negative organisms, 48% gram-positive, and 12% anaerobes. The most common bacteria were Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus and viridans group streptococci. Ninety-four percent of the cefixime group were cured compared with 96% of the amoxicillin group. Staphylococcus resistance was a problem in both groups, necessitating an occasional change to amoxicillin-clavulanate potassium in the amoxicillin group. Once-a-day antibiotics offer the potential for improved compliance in the treatment of sinusitis. Cefixime offers an additional benefit of covering beta-lactamase producing strains of bacteria which are increasing in incidence and resistant to many penicillins.

Topics: Administration, Oral; Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Capsules; Cefixime; Cefotaxime; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Prospective Studies; Remission Induction; Sinusitis; Time Factors

Oral fleroxacin, 400 mg once a day, and oral amoxicillin/clavulanate potassium (AMX/CP), 400 mg/125 mg three times a day, administered for 4-21 days, were compared for efficacy and safety in the treatment of skin and soft tissue infections. A total of 113 patients were enrolled in a multicenter, randomized, double-blind trial; 57 were assigned to fleroxacin and 56 to AMX/CP. A total of 22 and 33 patients in the fleroxacin and AMX/CP groups, respectively, were evaluable for efficacy. The most common diagnoses were skin abscess (14; 62%) and wound infections (5; 23%) in the fleroxacin group and skin abscess (17; 52%) and skin ulcer (9; 27%) in the AMX/CP group. A total of 20 (91%) of the fleroxacin-treated patients and 29 (88%) of the AMX/CP-treated patients were bacteriologically cured (two fleroxacin- and one AMX/CP-treated patients developed super-infection). The eradication rate for Staphylococcus aureus was 100% (11 of 11) in the fleroxacin group and 89% (17 of 19) in the AMX/CP group; 18 (82%) of the fleroxacin group and 25 (76%) of the AMX/CP group were clinically cured. Adverse events were seen in 22% (12 of 54) of the fleroxacin group and 25% (13 of 53) of the AMX/CP group. None were serious. Bacteriologic and clinical cure rates and safety results for the two groups were similar. The small sample size precluded statistical analysis at the 95% confidence level.

Topics: Administration, Oral; Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Bacterial Infections; Chi-Square Distribution; Clavulanic Acids; Double-Blind Method; Drug Therapy, Combination; Female; Fleroxacin; Humans; Male; Middle Aged; Skin Diseases, Bacterial; Treatment Outcome

In a multicenter, prospective, randomized trial, fleroxacin was compared with amoxicillin/clavulanate potassium (AMX/CP) for the treatment of infections of skin and soft tissue. Fleroxacin was given at a dosage of 400 mg once daily, and AMX/CP was given at a dosage of 500 mg/125 mg three times a day. Each was administered for 4-21 days. Adult patients with the clinical diagnosis of skin or soft tissue infections were eligible for enrollment. Patients were randomized in a 2:1 ratio. A total of 191 patients were enrolled; 126 took fleroxacin, and 65 took AMX/CP. Of these patients, 42 in the fleroxacin group and 26 in the AMX/CP group were evaluable for both clinical and bacteriologic efficacies. Patients with abscesses comprised the largest single category in each group. Principle reasons for exclusion included: patients lost to follow-up (17 [13%] fleroxacin, 12 [18%] AMX/CP); failure to isolate a causative pathogen (19 [15%] fleroxacin, 9 [14%] AMX/CP); and resistance to study drug (11 [9%] fleroxacin, 2 [3%] AMX/CP). Staphylococcus aureus was the most commonly isolated pathogen. Streptococcus group A, Staphylococcus coagulase-negative, Escherichia coli, and Proteus species, in decreasing order, were the next most common pathogens. Clinical and bacteriologic efficacy was excellent in both groups, with a cure rate of > or = 90%. There were two bacteriologic failures in each group. Patients taking fleroxacin complained of slightly more adverse events, which involved primarily the digestive and central nervous systems. The rate of withdrawal from the study because of adverse events was 4% in both groups. Fleroxacin, 400 mg given once daily, is safe and as effective as AMX/CP in the treatment of skin and soft tissue infections in adults.

Topics: Administration, Oral; Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Drug Therapy, Combination; Fleroxacin; Humans; Prospective Studies; Skin Diseases, Bacterial; Treatment Outcome

The objective of this open-label, randomized, multicenter study was to compare the efficacy and safety of fleroxacin, 400 mg administered orally once daily, and amoxicillin/clavulanate potassium (AMX/CP), 500 mg/125 mg administered orally three times daily, for 4-21 days to patients with skin and soft tissue infections (SSTIs). The specific diagnoses in both groups were primarily skin abscess, impetigo, and skin ulcer, as well as wound infection erysipelas, folliculitis, cellulitis, and lymphangitis. A total of 285 patients were randomized to treatment in a 2:1 ratio, 190 in the fleroxacin group and 95 in the AMX/CP group. Adult male or female inpatients or outpatients were included in the trial and were followed up after 3-5 days of therapy and 3-9 days after completion of therapy for assessment of bacteriologic, clinical, and safety parameters. The most frequently isolated pathogen in both treatment groups was Staphylococcus aureus. Bacteriologic cures were observed in 87 (76%) of 115 evaluable patients in the fleroxacin group and in 41 (72%) of 57 evaluable patients in the AMX/CP group. Clinical cure was seen in 86 (75%) of 114 patients in the fleroxacin group and 45 (79%) of 57 patients in the AMX/CP group. Clinical adverse events related to the trial medication were reported by 40 (21%) of 189 patients in the fleroxacin group and by 16 (17%) of 95 patients in the AMX/CP group. In both groups, most adverse events were mild or moderate in severity and involved the digestive system (primarily diarrhea, nausea, and vomiting). In the fleroxacin group, adverse events affecting the central nervous system (mainly dizziness, insomnia, somnolence) also were reported. In this study, both fleroxacin and amoxicillin/clavulanate potassium were effective and well tolerated in the treatment of skin and soft tissue infections.

Topics: Administration, Oral; Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Bacterial Infections; Clavulanic Acids; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Fleroxacin; Humans; Male; Middle Aged; Prospective Studies; Skin Diseases, Bacterial

The efficacy and safety of a once-daily oral regimen of 400 mg ceftibuten was compared with oral co-amoxiclav 500 mg three times daily in a multicentre, single-blind study. In patients with a bacteriologically confirmed infection, a successful clinical outcome was reported in 25 of 25 patients treated with ceftibuten and 10 of 10 patients treated with co-amoxiclav. In a further group of 88 patients, most of whom had been excluded from the primary efficacy evaluation because no pathogen was isolated pretreatment, overall successful clinical outcomes of 87% and 88% were reported for ceftibuten and co-amoxiclav, respectively. The duration of treatment and the time to resolution of the signs and symptoms of sinusitis were not significantly different in the two treatment groups. The incidence of adverse events was higher in the co-amoxiclav-treated patients (31% versus 15% in the ceftibuten group) as was the incidence of severe events (10% for co-amoxiclav-treated patients versus < 1% in the ceftibuten group). In summary, once-daily ceftibuten can be considered a safe and effective treatment for acute bacterial sinusitis.

Topics: Acute Disease; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Ceftibuten; Cephalosporins; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Single-Blind Method; Sinusitis

A prospective, multicentre, randomized trial was carried out in 19 hospitals in order to compare the efficacy of amoxycillin-clavulanic acid with cefotetan as antibiotic prophylaxis in patients undergoing elective colorectal surgery. Since the main purpose of the study was to demonstrate equivalence between the two regimens, the protocol planned the inclusion of 200 patients. Eligible patients were randomly assigned to receive either amoxycillin-clavulanic acid (2.2 g) or cefotetan (2 g) in a single infusion on the induction of anaesthesia. Failure of prophylaxis was defined as occurrence of infection of intestinal origin, either minor (wound cellulitis) or major (abscess, peritonitis, septicaemia) within the 30-day postoperative period. Among 221 randomized patients, 208 (105 amoxycillin-clavulanic acid, 103 cefotetan) aged 66 +/- 12 years (mean +/- SD) were evaluated while 13 were withdrawn. Colorectal cancer was the indication for surgery in 73% of cases. Eleven (10 +/- 6%, 95% confidence interval) and 13 (13 +/- 7%) failures were observed in the amoxycillin-clavulanic acid and cefotetan groups (P = 0.63 chi-square test) respectively. Most infections occurred before the 10th postoperative day (8% failures at this time, estimated by the Kaplan-Meier method). The results of the trial demonstrate that amoxycillin-clavulanic acid and cefotetan have similar efficacy when used for prophylaxis of infection after elective colorectal surgery.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefotetan; Clavulanic Acids; Colon; Colorectal Neoplasms; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Postoperative Complications; Premedication; Prospective Studies; Rectum; Surgical Wound Infection; Treatment Outcome; Urinary Tract Infections

The efficacy of amoxycillin-clavulanic acid for prevention of postoperative wound infection was compared with that of cefamandole in 150 patients at risk for infected bile while undergoing elective biliary surgery in a prospective, randomized study. The two groups were comparable for age, sex, risk factors, operative procedures and positive bile cultures. Similar numbers of patients had an uncomplicated postoperative course (amoxycillin-clavulanic acid 70%; cefamandole 73%). Four patients in each group developed wound infection. The incidence of postoperative pneumonia, urinary tract infection and number of days (+/- SD) in hospital (amoxycillin-clavulanic acid 10.1 +/- 4.7; cefamandole 9.7 +/- 5.6) were similar. The efficacy of amoxycillin-clavulanic acid and cefamandole in preventing wound sepsis in high-risk patients undergoing biliary surgery was similar. Economic considerations may favour the use of amoxycillin-clavulanic acid.

Topics: Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Biliary Tract Surgical Procedures; Cefamandole; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Premedication; Prospective Studies; Risk Factors; Surgical Wound Infection

Augmentin is a new combination manufactured by Smith Kline Beecham (Great Britain). It is composed of amoxycillin and clavulanic acid and has antibacterial activity. Augmentin was used in clinical trials in the therapy of 50 adult patients with suppurations after surgical operations on the organs of the abdominal cavity, general staphylococcal infections, pneumonia and prophylactically during the preoperative period. It was also used in the treatment of 30 children patients with bronchopulmonary affections and inflammatory otorhinolaryngological diseases. The clinical trials were performed in the Clinic of Infectious Diseases of the N. G. Gabrichevskiĭ Moscow Research Institute of Epidemiology and Microbiology. For comparison ampicillin was used in the trials. Augmentin was shown to be an efficient formulation with antibacterial activity which could be successfully used in the parenteral therapy of severe affections due to organisms sensitive to it. In the treatment of the children patients with pneumonia augmentin by its therapeutic efficacy proved to be superior to ampicillin. The tolerance of augmentin was good.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Drug Evaluation; Drug Therapy, Combination; Drug Tolerance; Humans; Infant; Middle Aged; Premedication

Augmentin suspension (amoxycillin+clavulanic acid) was estimated in clinico-laboratory studies with respect to children suffering from pyoinflammatory diseases of various localization and its high efficacy was shown. Good and satisfactory results were recorded in 96.3 per cent of the cases in the treatment (monotherapy) and afterwards in the patients, adverse reactions such as nausea and vomiting being recorded only in 1 patient. The therapy with augmentin led to normalization of the microflora of the upper respiratory tract mucosa and a 1.5-fold increase in the neutrophil engulfment index.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Drug Tolerance; Focal Infection; Humans; Infant; Infant, Newborn; Microbial Sensitivity Tests; Opportunistic Infections; Suspensions

Loracarbef (LY 163892), a beta-lactam antibiotic (carbacephem), was compared with amoxicillin/clavulanate potassium in a 10-day, single-blind, randomized parallel trial in the treatment of acute bacterial maxillary sinusitis. Based on posttherapy aspirate and culture, there was a 95.2% bacteriologic cure rate in patients receiving loracarbef (400 mg twice daily) and an 86.7% cure rate in patients receiving amoxicillin/clavulanate (500/125 mg three times daily) (p = 0.359). Loracarbef was comparable in efficacy to amoxicillin/clavulanate with a more desirable safety profile.

Topics: Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cephalosporins; Clavulanic Acids; Decision Trees; Drug Therapy, Combination; Female; Humans; Male; Maxillary Sinusitis; Middle Aged; Severity of Illness Index

We prospectively studied 271 infants and children (2 months to 7 years of age) with acute otitis media (AOM) for viral and bacterial causes, outcome at the end of therapy, and frequency of recurrence within 1 month. Comprehensive virologic methods, including viral antigen detection, cell culture, and serologic studies, were used to diagnose viral infection of the respiratory tract, middle ear, or both. Evidence of viral infection was found in 46% (124/271) of patients with AOM. Sixty-six patients (24%) had virus or viral antigen in the middle ear fluid; 50 of these patients (76%) also had bacteria in middle ear fluid, and 16 (24%) had virus alone. More patients with AOM and combined bacterial and viral infection (51%) had persistent otitis (3 to 12 days after institution of antibiotic treatment), compared with those with only bacterial otitis (35%; p = 0.05) or patients with only viral infection (19%; p less than 0.01). Of patients with only viral infection, 4 of 10 with virus in middle ear fluid had persistent otitis, compared with none of 11 patients who had virus only in nasal wash specimens or whose viral infection was diagnosed only by serologic studies. Our data suggest that viruses interact with bacteria and that concurrent viral infection can significantly worsen the clinical course of bacterial AOM. The presence of virus in middle ear fluid may contribute to the pathogenesis and outcome of bacterial AOM. The mechanism of these interactions deserve further investigation.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefpodoxime; Ceftizoxime; Clarithromycin; Clavulanic Acids; Drug Therapy, Combination; Erythromycin; Female; Humans; Infant; Male; Otitis Media; Respiratory Tract Infections; Treatment Outcome; Virus Diseases

The efficacy and safety of loracarbef, a new beta-lactam antibiotic, was compared with that of amoxicillin-clavulanate potassium in the treatment of bacterial acute otitis media with effusion. A double-blind format was utilized to administer 10-day, randomized, parallel treatment regimens to patients who were between 6 months and 12 years of age. The most prevalent causative pathogens found in the two treatment groups were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella (Branhamella) catarrhalis. The percentages of favorable posttherapy clinical responses in evaluable patients were similar for both drugs: 87.3% (124/142) of the loracarbef group, compared with 91.5% (130/142) of the amoxicillin-clavulanate group, showed favorable responses within 72 hours after treatment. Ten to sixteen days after treatment, 68.1% of the loracarbef group, compared with 76.1% of the amoxicillin-clavulanate group, showed favorable responses. More patients in the amoxicillin-clavulanate group reported treatment-emergent events: 46.1% compared with 35.8% in the loracarbef group (p = 0.023). Diarrhea was the most frequently reported event, occurring in 13.3% of the loracarbef group and in 26.3% of the amoxicillin-clavulanate group (p less than 0.001). Vomiting was reported by 5.8% of the loracarbef group and 10.3% of the amoxicillin-clavulanate group (p = 0.072). Loracarbef is comparable in efficacy to amoxicillin-clavulanate in the treatment of bacterial acute otitis media with effusion and has a more desirable safety profile.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cephalosporins; Clavulanic Acids; Double-Blind Method; Drug Evaluation; Drug Therapy, Combination; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Otitis Media with Effusion; Streptococcus pneumoniae

The results of an open randomised trial comparing the efficacy of parenteral and oral ofloxacin with that of amoxycillin clavulanate are reported. Of 121 patients enrolled, 92 were clinically evaluable, of whom 59 were treated with ofloxacin and 33 with amoxycillin clavulanate. In the ofloxacin group all patients improved clinically, while in the amoxycillin clavulanate group 94% improved and 6% were clinical failures. In the ofloxacin group 95% showed satisfactory bacteriological response, while in the amoxicillin clavulanate group the bacteriological response was judged satisfactory in 82% of the patients. Seven percent of the patients had mild side effects (headache, nausea, vomiting and skin rashes). All of these side effects disappeared after treatment. We conclude that ofloxacin is a safe and effective drug in oral and parenteral forms for the treatment of lower respiratory tract infections.

Topics: Administration, Oral; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Injections, Intravenous; Male; Middle Aged; Ofloxacin; Respiratory Tract Infections

It is not yet known how important bacterial colonisation of the newborn is but in most maternity units this, when it occurs, is treated by parenteral antibiotic therapy. We have, in a prospective study, given antibiotics orally (amoxycillin or clavulanic acid-amoxycillin) in neonates who were colonised by bacteria, and have studied their clinical progress in the first month of life, using a questionnaire to be filled in by the parents. There were 119 neonates treated in 19 months and of these 87.4% of the parents replied to the questionnaires. The children did well in every case. A pharmacokinetic study showed that 76% of the amoxycillin given by mouth was absorbed. It seems, therefore, to us to be useful to give antibiotic treatment by mouth in these neonates.

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Infant, Newborn; Male; Nurseries, Hospital; Prospective Studies; Surveys and Questionnaires

In a prospective study, 105 infants aged 3-12 months with acute otitis media were randomly assigned to one of three treatment groups: amoxycillin/clavulanate ('Augmentin') alone (36 patients), myringotomy plus placebo (35 patients), or augmentin plus myringotomy (34 patients). The last two groups were double-blinded. Bacterial pathogens, mainly Haemophilus influenzae (of which 20% were beta-lactamase producers) and Streptococcus pneumoniae, were isolated from 60% of the ear exudates and all isolates were sensitive to augmentin. Most of the infants improved clinically within 3-6 days irrespective of the treatment protocol. As judged by otoscopy, 60% of the patients receiving augmentin, with or without myringotomy, recovered completely compared with 23% of patients treated with myringotomy plus placebo. Treatment with augmentin was also more effective than myringotomy with regard to persistence of ear infection. In the myringotomy plus augmentin group closure of the incision and resolution of the discharge from the incision site was faster than in the myringotomy plus placebo group. The addition of myringotomy to augmentin did not seem to affect either the persistence of the infection after treatment or the residual middle ear effusion.

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Clinical Trials as Topic; Combined Modality Therapy; Diarrhea; Double-Blind Method; Drug Administration Schedule; Evaluation Studies as Topic; Female; Follow-Up Studies; Humans; Infant; Male; Otitis Media with Effusion; Prospective Studies; Random Allocation; Time Factors; Tympanic Membrane

One hundred children with clinically diagnosed bacterial pneumonia were assigned at random to receive treatment with either amoxycillin (250 or 500 mg) or amoxycillin (250 or 500 mg) plus clavulanic acid (62.5 or 125 mg) 3-times daily, dosage and duration of treatment being determined by the severity of the condition. There were no clinically significant differences between the two groups on entry and the mean duration of treatment was 6.8 days in both. By Day 3 of treatment, significant differences in improvement in chest pain, dyspnoea, pyrexia and sputum production were noted in favour of amoxycillin/clavulanic acid. The response to treatment was significantly better in the combination group with an excellent or good response recorded in 60% and 30% of patients, compared with 26% and 36% in the amoxycillin group. Only 2 adverse reactions were reported, 1 case each of skin rash and diarrhoea in the combined group. The overall clinical efficacy rate of 93.8% in amoxycillin/clavulanic acid-treated patients was significantly better than the 60.4% clinical success recorded in the amoxycillin group.

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Pneumonia

Twenty-six hospitalized and 14 ambulatory children with the most common bacterial infections were treated with augmentin, intravenously and orally. In 90% of the cases in this study a clinical and microbiological cure was obtained. The number of side-effects was no higher than those caused by other drugs. Augmentin provides safe and effective therapy for infections commonly seen in the pediatric population.

Topics: Ambulatory Care; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Hospitalization; Humans; Infant

A prospective, randomized controlled study was carried out in 104 patients to compare clavulanate-potentiated amoxycillin ('Augmentin') with a combination of cephalosporins (cefazoline and cefadroxil) supplemented with metronidazole in the treatment of abdominal septic states, suspected or proven after surgical intervention. Patients on 'Augmentin' received 1.2 g (1 g amoxycillin plus 200 mg clavulanic acid) intravenously 3-times daily for a mean of 6.6 days, then 375 mg (250 amoxycillin plus 125 mg clavulanic acid) orally for a further 6.4 days. Patients on the standard therapy received 1 g cefazoline intravenously 4-times daily plus 500 mg metronidazole intravenously 3-times daily for 7 days, then 500 mg cefadroxil orally 4-times daily for a mean of 6.6 days. Evaluation of the patients' condition was undertaken after 24 hours, 3 days and 7 days. The results showed a significantly better response to treatment in the 'Augmentin' group, as judged by the amelioration of clinical symptoms, bacteriological findings, and tolerance. All the patients treated with 'Augmentin' showed an excellent or satisfactory overall response at Day 7 compared with 76% of those receiving the standard therapy.

Topics: Abdomen; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefadroxil; Cefazolin; Clavulanic Acids; Clinical Trials as Topic; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Metronidazole; Prospective Studies; Random Allocation

A small prospective trial was conducted to evaluate the effectiveness and safety of a single antibiotic regimen, Augmentin, compared with a combination regimen of cefuroxime and metronidazole in the treatment of serious post-operative sepsis. Both regimens used were effective against Bacteroides and other anaerobes, with a similar satisfactory cure rate and no serious side effects. Intravenous Augmentin was easy to use and the change to oral therapy was significantly quicker than in the cefuroxime-metronidazole treatment arm. No significant resistance or serious adverse reaction was noted. The majority of patients had more than one site of infection, making selective antibiotic treatment difficult.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Cefuroxime; Cephalosporins; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Male; Metronidazole; Middle Aged; Postoperative Complications; Prospective Studies; Randomized Controlled Trials as Topic

BRL 25000 is a combination of a newly-developed beta-lactamase inhibitor clavulanic acid (CVA) and amoxicillin (AMPC) in the ratio of 1 to 2. The drug, as medium granules, was administered to a total of 92 pediatric patients, ranging in age from 1 month to 13 years and 2 months, with cutaneous/soft tissue infections (70 impetigo, 6 furuncle, 7 phlegmon, 6 abscess and 3 cases of lymphadenitis). It was found subsequently that 2 of the 70 impetigo cases had received topical antibiotic medication and these were excluded from clinical evaluation to give a total of 90 evaluable cases. The daily dosage of BRL 25000 ranged from 23.7 to 75.0 mg/kg, given in 3 or 4 divided doses (average 48.5 mg/kg) and the duration of treatment was for 3 to 13 days (average 6 days). Clinical isolates of S. aureus from the above cases were examined for beta-lactamase production and their susceptibility determined to the 5 antibiotics BRL 25000, AMPC, CVA, cephalexin (CEX) and cefaclor (CCL). The drugs' clinical effects on the various diseases, bacteriological effects and side effects were also studied. At an inoculum of 10(8) cells/ml, major MICs of BRL 25000, AMPC, CVA, CEX and CCL against 71 strains of S. aureus, including beta-lactamase negative ones, were 3.13 mcg/ml, 12.5 mcg/ml, 50 mcg/ml, 12.5 mcg/ml and 12.5 mcg/ml, accounting for 60.6, 38.0, 49.3, 38.0 and 43.7% of the strains respectively, whilst at an inoculum of 10(6) cells/ml, major MICs were 1.56 mcg/ml, 3.13 mcg/ml, 25 mcg/ml, 6.25 mcg/ml and 3.13 mcg/ml, accounting for 57.7, 33.8, 83.1, 50.7 and 54.9%, respectively. It was noted that all drugs tended to show smaller MIC values as the inoculum size was reduced to 10(6) cells/ml and that BRL 25000 showed the most potent antibacterial activity of all 5 drugs.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Drug Combinations; Female; Humans; Infant; Male; Penicillin Resistance; Skin Diseases, Infectious; Staphylococcus aureus

MICs of BRL 25000, a combination of a newly developed beta-lactamase inhibitor CVA and AMPC in the ratio of 1 to 2, were determined against a number of bacterial strains and compared with those of AMPC, CVA, CEX and CCL. The 98 bacterial strains tested included 2-S. aureus, 23-H. influenzae, 25-E. coli, 22-K. pneumoniae and 26-P. mirabilis. In pharmacokinetic studies, BRL 25000 medium granules were administered to groups of 3 male subjects, aged between 7 years 8 months and 9 years 5 months, at doses of 10, 15 and 20 mg/kg, 2 hours after a meal. The resultant serum and urine concentrations and drug recoveries were measured. Furthermore, BRL 25000 was administered to a total 43 patients (2-pharyngitis, 8-tonsillitis, 3-bronchitis, 2-pneumonia and 28-urinary tract infection) whom clinically evaluable. An average daily dosage of 45.3 mg/kg was given, in 3 or 4 divided doses, for a period of 8 days on average. Clinical and bacteriological effects as well as side effects were studied. In the microbiological studies on 98 clinical strains, including beta-lactamase negative bacteria, BRL 25000 showed MICs against the Gram-positive cocci (2-S. aureus) superior to the other 4 drugs at inoculum sizes of 10(8) and 10(6) cells/ml. For the Gram-negative bacilli, against H. influenzae at inoculum sizes of 10(8) and 10(6) cells/ml, BRL 25000 was inferior in the small MIC range but superior in the large MIC range to AMPC, and was superior to the other 3 drugs. Against E. coli at an inoculum of 10(8) cells/ml, BRL 25000 showed antibacterial activity next to AMPC and CCL whilst at an inoculum of 10(6) cells/ml, it was inferior in the small MIC range but superior in the large MIC range to AMPC and CEX and was inferior to CCL but superior to CVA. Against K. pneumoniae at an inoculum of 10(8) cells/ml, BRL 25000 was equal to AMPC, CVA and CEX but inferior to CCL, whilst at an inoculum of 10(6) cells/ml, it was inferior to CCL but superior to the other 3 drugs. Against P. mirabilis at inoculum sizes of 10(8) and 10(6) cells/ml, BRL 25000 was inferior in the small MIC range but equal or superior in the large MIC range to AMPC, and was superior to CVA and CEX.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Dosage Forms; Drug Combinations; Female; Humans; Infant; Male; Penicillin Resistance

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Clavulanic Acids; Clinical Trials as Topic; Costs and Cost Analysis; Drug Combinations; Humans; Kinetics

Sixty-four patients were entered into a double-blind study of Augmentin and cefaclor. Pathogenic bacteria were recovered from twenty-one patients who received Augmentin and seventeen patients who received cefaclor. The primary diagnoses were pyodermas and impetigo, as well as cellulitis, folliculitis, infected skin structure, and infected surgical sites. Eighty-one percent of the Augmentin-treated patients were classified as successfully treated, based on clinical and bacteriologic criteria, as were eighty-nine percent of the patients treated with cefaclor. Side effects were minimal in both groups; no laboratory abnormalities were found. Both Augmentin and cefaclor are useful oral antimicrobial agents in the treatment of infections of the skin and skin structure.

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cefaclor; Cephalexin; Clavulanic Acids; Clinical Trials as Topic; Double-Blind Method; Drug Combinations; Female; Humans; Male; Penicillin Resistance; Skin Diseases, Infectious

Topics: Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Clinical Trials as Topic; Drug Combinations; Female; Humans; Male; Middle Aged

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Drug Combinations; Family Practice; Female; Humans; Male; Sulfamethoxazole; Trimethoprim; Trimethoprim, Sulfamethoxazole Drug Combination

To investigate the efficacy and safety of home-treatment with oral piv-mecillinam or amoxicillin-clavulanate in children with acute pyelonephritis.. Children aged over 6 months diagnosed with culture confirmed pyelonephritis at Danish Paediatric Departments were home-treated with piv-mecillinam (tablets) or amoxicillin-clavulanate (liquid or tablets). Follow-up was performed by phone (second treatment day) and clinical review of the patients in the hospital (day three).. Four hundred eighteen children were included. In total, 333/418 (80%) responded well to the initial oral antibiotic treatment. 85/418 (20%) were changed to another treatment of these 47/418 (11%) to a second-line oral antibiotic and 38/418 (9%) to intravenous antibiotics due to insufficient clinical improvement or bacterial resistance. Bacterial resistance was similar for piv-mecillinam and amoxicillin-clavulanate: 4/74 (5%) versus 33/333 (10%) (p = 0.22). Insufficient clinical improvement, despite no resistance, primarily occurred in children treated with piv-mecillinam: 16/74 (22%) versus 28/344 (8%) (p < 0.001), and predominantly occurred in piv-mecillinam treated children <5 years: 7/20 (35%) versus 9/54 (17%) (p < 0.05), potentially because of problems with piv-mecillinam tablets. In the study population no cases of death or septicemia developed after start of initial oral treatment.. A home-treatment regime for pyelonephritis in children >6 months is safe; however, during treatment, clinical re-evaluation is required as in 20% of cases a change in treatment was necessary.

Topics: Acute Disease; Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Humans; Infant; Pyelonephritis

The disease caused by Enterococcus lacertideformus is multisystemic and ultimately fatal. Since its emergence, the bacterium has significantly impacted the captive breeding programs of the extinct in the wild Christmas Island Lister's gecko (Lepidodactylus listeri) and blue-tailed skink (Cryptoblepharus egeriae). The bacterium's pathogenicity, inability to grow in-vitro, and occurrence beyond the confines of Christmas Island necessitated the development of an experimental infection and treatment model. Asian house geckos (Hemidactylus frenatus) were challenged with a single dose of E. lacertideformus inoculum either by mouth, application to mucosal abrasion or skin laceration, subcutaneous injection, coelomic injection, or via co-housing with an infected gecko. Five healthy geckos acted as controls. Each transmission route resulted in disease in at least 40% (n = 2) geckos, expanding to 100% (n = 5) when E. lacertideformus was applied to skin laceration and mucosal abrasion groups. Incubation periods post-infection ranged between 54 and 102 days. To determine the efficacy of antibiotic treatment, infected geckos were divided into six groups (enrofloxacin 10 mg/kg, per os (PO), every 24 h (q24), amoxicillin-clavulanic acid 10 mg/kg, PO, q24, enrofloxacin 10 mg/kg combined with amoxicillin-clavulanic acid 10 mg/kg, PO, q24, rifampicin 15 mg/kg, PO, q24, clarithromycin 15 mg/kg, PO, q24, and untreated controls) for 21 days. Response to treatment was assessed by the change in lesion size, bacterial dissemination, and histological evidence of a host immune response. Irrespective of the antibiotic given, histology revealed that geckos inoculated by skin laceration were observed to have more extensive disease spread throughout the animal's body compared to other inoculation routes. The reduction in the average surface area of gross lesions was 83.6% for geckos treated with enrofloxacin, followed by the combination therapy amoxicillin-clavulanic acid and enrofloxacin (62.4%), amoxicillin-clavulanic acid (58.2%), rifampicin (45.5%), and clarithromycin (26.5%). Lesions in geckos untreated with antibiotics increased in size between 100 and 300%. In summary, enrofloxacin and amoxicillin-clavulanic acid show promising properties for the treatment of E. lacertideformus infection in geckos. The Asian house gecko E. lacertideformus infection model therefore provides foundational findings for the development of effective therapeutic treatment protocols aimed at conserving

Topics: Amoxicillin-Potassium Clavulanate Combination; Animals; Anti-Bacterial Agents; Bacterial Infections; Clarithromycin; Disease Models, Animal; Enrofloxacin; Enterococcus; Humans; Lizards

Antimicrobial resistance is a growing threat to the world's ability to prevent and treat infections. Links between quantitative antibiotic use and the emergence of bacterial resistance are well documented. This study presents benchmark antimicrobial use (AMU) rates for inpatient adult populations in acute-care hospitals across Canada.. In this retrospective surveillance study, acute-care adult hospitals participating in the Canadian Nosocomial Infection Surveillance Program (CNISP) submitted annual AMU data on all systemic antimicrobials from 2009 to 2016. Information specific to intensive care units (ICUs) and non-ICU wards were available for 2014-2016. Data were analyzed using defined daily doses (DDD) per 1000 patient days (DDD/1000pd).. Between 2009 and 2016, 16-18 CNISP adult hospitals participated each year and provided their AMU data (22 hospitals participated in ≥1 year of surveillance; 11 in all years). From 2009 to 2016, there was a significant reduction in use (12%) (from 654 to 573 DDD/1000pd, p = 0.03). Fluoroquinolones accounted for the majority of this decrease (47% reduction in combined oral and intravenous use, from 129 to 68 DDD/1000pd, p < 0.002). The top five antimicrobials used in 2016 were cefazolin (78 DDD/1000pd), piperacillin-tazobactam (53 DDD/1000pd), ceftriaxone (49 DDD/1000pd), vancomycin (combined oral and intravenous use was 44 DDD/1000pd; 7% of vancomycin use was oral), and ciprofloxacin (combined oral and intravenous use: 42 DDD/1000pd). Among the top 10 antimicrobials used in 2016, ciprofloxacin and metronidazole use decreased significantly between 2009 and 2016 by 46% (p = 0.002) and 26% (p = 0.002) respectively. Ceftriaxone (85% increase, p = 0.0008) and oral amoxicillin-clavulanate (140% increase, p < 0.0001) use increased significantly but contributed only a small component (8.6 and 5.0%, respectively) of overall use.. This study represents the largest collection of dispensed antimicrobial use data among inpatients in Canada to date. Between 2009 and 2016, there was a significant 12% decrease in AMU, driven primarily by a 47% decrease in fluoroquinolone use. Modest absolute increases in parenteral ceftriaxone and oral amoxicillin-clavulanate use were noted but contributed a small amount of total AMU. Ongoing national surveillance is crucial for establishing benchmarks and antimicrobial stewardship guidelines.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antimicrobial Stewardship; Bacterial Infections; Canada; Ceftriaxone; Cross Infection; Drug Resistance; Fluoroquinolones; Hospitals; Humans; Inpatients; Retrospective Studies

It is commonly recommended that microbiological assessment should accompany the use of antibiotics prone to resistance. We sought to estimate the rate of microbiology testing and compare this to dispensing of the World Health Organization classified "watch" group antibiotics in primary care.. Data from a cohort of older adults (mean age 69 years) were linked to Australian national health insurance (Pharmaceutical Benefits Scheme & Medicare Benefits Schedule) records of community-based antibiotic dispensing and microbiology testing in 2015. Participant characteristics associated with greater watch group antibiotic dispensing and microbiology testing were estimated using adjusted incidence rate ratios (aIRR) and 95% confidence intervals (CI) in multivariable zero-inflated negative binomial regression models.. In 2015, among 244,299 participants, there were 63,306 watch group antibiotic prescriptions dispensed and 149,182 microbiology tests conducted; the incidence rate was 0.26 per person-year for watch group antibiotic dispensing and 0.62 for microbiology testing. Of those antibiotic prescriptions, only 19% were accompanied by microbiology testing within - 14 to + 7 days. After adjusting for socio-demographic factors and co-morbidities, individuals with chronic respiratory diseases were more likely to receive watch group antibiotics than those without, e.g. asthma (aIRR:1.59, 95%CI:1.52-1.66) and chronic obstructive pulmonary disease (COPD) (aIRR:2.71, 95%CI:2.48-2.95). However, the rate of microbiology testing was not comparably higher among them (with asthma aIRR:1.03, 95%CI:1.00-1.05; with COPD aIRR:1.00, 95%CI:0.94-1.06).. Priority antibiotics with high resistance risk are commonly dispensed among community-dwelling older adults. The discord between the rate of microbiology testing and antibiotic dispensing in adults with chronic respiratory diseases suggests the potential for excessive empirical prescribing.

Topics: Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Asthma; Bacterial Infections; Cohort Studies; Comorbidity; Drug Prescriptions; Female; Humans; Independent Living; Male; Middle Aged; National Health Programs; New South Wales; Pulmonary Disease, Chronic Obstructive

Empiric antibiotic therapy for suspected hematogenous vertebral osteomyelitis (HVO) should be initiated immediately in seriously ill patients and may be required in those with negative microbiological results. The aim of this study was to inform the appropriate selection of empiric antibiotic regimens for the treatment of suspected HVO by analyzing antimicrobial susceptibility of isolated bacteria from microbiologically proven HVO.. We conducted a retrospective chart review of adult patients with microbiologically proven HVO in five tertiary-care hospitals over a 7-year period. The appropriateness of empiric antibiotic regimens was assessed based on the antibiotic susceptibility profiles of isolated bacteria.. In total, 358 cases of microbiologically proven HVO were identified. The main causative pathogens identified were methicillin-susceptible Staphylococcus aureus (33.5%), followed by methicillin-resistant S. aureus (MRSA) (24.9%), Enterobacteriaceae (19.3%), and Streptococcus species (11.7%). Extended spectrum β-lactamase (ESBL)-producing Enterobacteriaceae and anaerobes accounted for only 1.7% and 1.4%, respectively, of the causative pathogens. Overall, 73.5% of isolated pathogens were susceptible to levofloxacin plus rifampicin, 71.2% to levofloxacin plus clindamycin, and 64.5% to amoxicillin-clavulanate plus ciprofloxacin. The susceptibility to these oral combinations was lower in cases of healthcare-associated HVO (52.6%, 49.6%, and 37.6%, respectively) than in cases of community-acquired HVO (85.8%, 84.0%, and 80.4%, respectively). Vancomycin combined with ciprofloxacin, ceftriaxone, ceftazidime, or cefepime was similarly appropriate (susceptibility rates of 93.0%, 94.1%, 95.8%, and 95.8%, respectively).. Based on our susceptibility data, vancomycin combined with a broad-spectrum cephalosporin or fluoroquinolone may be appropriate for empiric treatment of HVO. Fluoroquinolone-based oral combinations may be not appropriate due to frequent resistance to these agents, especially in cases of healthcare-associated HVO.

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; beta-Lactamases; Ciprofloxacin; Clindamycin; Drug Therapy, Combination; Empirical Research; Enterobacteriaceae; Female; Gene Expression; Humans; Levofloxacin; Male; Methicillin-Resistant Staphylococcus aureus; Microbial Sensitivity Tests; Middle Aged; Osteomyelitis; Retrospective Studies; Rifampin; Spine; Streptococcus; Vancomycin

Topics: Abdominal Pain; Aged; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Capsule Endoscopy; Double-Balloon Enteroscopy; Enterococcus faecalis; Erythromycin; Escherichia coli; Female; History, 18th Century; Humans; Intestinal Diseases; Severity of Illness Index; Treatment Outcome

To examine whether short-term use of azithromycin increases the risk of sensorineural hearing loss (SNHL) in adults with uncomplicated infections.. A retrospective cohort study using Medicaid claims data, 1999 to 2010.. Adults (18-64 years old) who had continuous enrollment in Medicaid for the 12 months (baseline) before the date of first dispensation (index date) of oral azithromycin or amoxicillin ± clavulanate for uncomplicated infections.. We operationalized sensorineural hearing loss (SNHL) by a charge for audiometry and followed by a diagnosis of SNHL within 30 days.. We adjusted for the baseline covariates through propensity score matching. Adults were followed for up to 120 days after the index date. The hazard of SNHL in azithromycin-exposed adults was compared with those who had amoxicillin ± clavulanate using a Cox proportional hazard model. We performed several sensitivity analyses by varying the follow-up time, SNHL definition, adjusting for cumulative antibiotic use, and switching exposure status during the follow-up period.. A total of 493,774 patients entered the study cohort. The unadjusted incidence rates of SNHL were 38 and 41 cases per 10,000 patient-years following exposure to azithromycin and amoxicillin ± clavulanate, respectively. The adjusted (matched) hazard ratio (HR) of SNHL for azithromycin versus amoxicillin ± clavulanate was 0.91 (95% confidence interval [CI], 0.77-1.07). The sensitivity analyses findings were consistent with the primary analysis.. Azithromycin short-term use was not associated with an increased risk of SNHL in comparison to amoxicillin ± clavulanate.

Topics: Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Audiometry; Azithromycin; Bacterial Infections; Female; Hearing Loss, Sensorineural; Humans; Incidence; Male; Medicaid; Middle Aged; Retrospective Studies; United States; Young Adult

This script gives a pragmatic advice for general dentists on accurate use of amoxicillin with clavulanic acid considering current literature at acute inflammatory disease. In absence of contraindications a twice daily formulation of 1g amoxicillin with clavulanic acid is the first choice for concomitant therapy after treating the cause of inflammation or prophylaxis. Compared to clindamycin the concentration of amoxicillin in teeth and bone (Hallig 2014) is higher and has less gastrointestinal side-effects (Bax 2007). Furthermore it is prescribable during pregnancy and lactation. With these advantages amoxicillin with clavulanic acid is the first choice of antibiotics in general dental medicine.

Topics: Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Bacterial Infections; Clindamycin; Dose-Response Relationship, Drug; Female; Guideline Adherence; Humans; Mouth Diseases; Opportunistic Infections; Pregnancy; Research

Pyelonephritis is a common infection in childhood and may cause renal scarring. The aim was to determine an effective oral antibiotic treatment of first time pyelonephritis in children.. The study is a retrospective analysis of positive urine cultures collected at a Danish paediatric department from 2010-2013. Urine samples from 378 children aged 0-15.9 years, without renal anomalies and treated for first time pyelonephritis, were included. The urine pathogens and antimicrobial susceptibilities were analysed.. The most common aetiologic agents found were Escherichia coli (85%), Klebsiella species and other Enterobacteriaecea (9.7%) and Enterococcus species (5.3%). Escherichia coli was significantly more common in girls than in boys (90% vs 74%, p < 0.001) and in children older than 6 months (89% vs 77%, p < 0.001). Children younger than 6 months had a higher prevalence of other Gram-negative rods (16% vs 7%, p < 0.001). These differences may be due to boys representing 63% of patients in the youngest age group compared to 16% of older children (p < 0.001). For all urine isolates, piv-mecillinam and amoxicillin-clavulanate had the lowest resistance rates of 6.9% and 7.2%, respectively, and 6% for both antimicrobials in patients older than 6 months. Uropathogens from boys above 6 months of age were more resistant to piv-mecillinam compared to girls (25% vs 2.4%, p < 0.001).. This study recommends piv-mecillinam or amoxicillin-clavulanate as empirical treatment of first time pyelonephritis in Danish children from 6 months of age. Age and gender of patients should be taken into consideration when initiating empirical treatment.

Topics: Administration, Oral; Adolescent; Age Factors; Amdinocillin Pivoxil; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Denmark; Drug Resistance, Bacterial; Enterococcus; Escherichia coli; Female; Hospitals, Pediatric; Humans; Infant; Infant, Newborn; Klebsiella; Male; Pyelonephritis; Retrospective Studies; Sex Factors; Urine

Topics: Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Bacteroides; Bacteroidetes; Clindamycin; Humans; Inpatients; Microbial Sensitivity Tests; Poland

Topics: Amoxicillin-Potassium Clavulanate Combination; Analgesics, Opioid; Animals; Anti-Bacterial Agents; Anti-Inflammatory Agents, Non-Steroidal; Bacterial Infections; Dog Diseases; Dogs; Male; Meloxicam; Osteonecrosis; Thiazines; Thiazoles; Tramadol

To demonstrate clinical value of clavulanic acid/amoxicillin (CVA/AMPC) 1:14 combination dry syrup for acute bacterial rhinosinusitis (ABRS), the efficacy and safety were evaluated in a multicenter, open-label, uncontrolled study in 27 children with ABRS. The proportion of subjects who were 'cured' at the test of cure as the primary endpoint was 88.5%. In subjects with a major pathogenic bacteria at baseline (i.e., Streptococcus pneumoniae, Haemophilus influenzae and Moraxella catarrhalis) bacterial eradication was achieved in ≥ 80% of the subjects with the exception of β-lactamase non-producing ampicillin resistant H. influenzae: BLNAR and β-lactamase producing ampicillin resistant H. influenzae: BLPAR (β-lactamase producing amoxicillin/clavulanic acid resistant H. influenzae: BLPACR). The MIC of CVA/AMPC (1:14) was not higher than 4 μg/mL for all pathogens except one strain each of BLNAR and BLPAR (BLPACR). Drug-related adverse events were reported in 19% of patients (5/27 patients). All of the reported drug-related adverse events were classified as gastrointestinal disorders that have been commonly reported with antibacterial drugs. These results indicate that CVA/AMPC (1:14) was clinically useful for the treatment of ABRS and is also suggested that was effective especially for the treatment of ABRS in children caused by beta-lactamase-producing bacteria including M. catarrhalis.

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; beta-Lactamase Inhibitors; Child; Child, Preschool; Humans; Infant; Rhinitis; Sinusitis

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Chronic Disease; Denmark; Humans; Low Back Pain; Magnetic Resonance Imaging

Current recommendations for empirical antimicrobial therapy in spontaneous bacterial peritonitis (SBP) are based on quite old trials. Since microbial epidemiology and the management of patients have changed, whether these recommendations are still appropriate must be confirmed.. An observational study that exhaustively collected the clinical and biological data associated with positive ascitic fluid cultures was conducted in four French university hospitals in 2010-2011.. Two hundred and sixty-eight documented positive cultures were observed in 190 cirrhotic patients (median age 61.5 years, 58.5% Child score C). Of these, 57 were classified as confirmed SBP and 140 as confirmed bacterascites. The predominant flora was Gram-positive cocci, whatever the situation (SBP, bacterascites, nosocomial/health-care related or not). Enteroccocci (27.7% E. faecium) were isolated in 24% of the episodes, and in 48% from patients receiving quinolone prophylaxis. E. coli were susceptible to amoxicillin-clavulanate and to third-generation cephalosporins in 62.5% and 89.5% of cases, respectively. No single antibiotic allowed antimicrobial coverage of more than 60%. Only combinations such as amoxicillin + third-generation cephalosporin or cotrimoxazole allowed coverage close to 75-80% in non-nosocomial episodes. Combinations based on broader spectrum antibiotics should be considered for empirical therapy of nosocomial infections.. Our study confirmed the changing spectrum of pathogens in SBP and bacterascites, and the need for more complex antibiotic strategies than those previously recommended. Our findings also underline the need for new clinical trials conducted in the current epidemiological context.

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Anti-Infective Agents; Ascitic Fluid; Bacterial Infections; Cross Infection; Drug Resistance, Bacterial; Escherichia coli; Female; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Peritonitis; Treatment Outcome

It is common surgical practice to take a specimen for microbial culture and sensitivity when incising and draining infections of odontogenic origin in the head and neck. We aimed to find out if routine testing has any therapeutic value. We retrospectively studied 90 patients (57 male and 33 female) admitted to Northampton General Hospital for treatment of odontogenic infections, and reviewed admission details, antimicrobial treatment, microbiological findings and their sensitivity or resistance, and complications. Specimens were sent from 72 (80%) patients of which 61 (85%) were infected. The most commonly isolated organism was Streptococcus viridans. Interim reports were published after a mean of 3 days (range 1-4), and 94% of patients were discharged within a mean of 2 days (range 0-9) postoperatively. Almost 95% of patients were discharged before results were available, and there were no reported complications. We therefore suggest that microbial culture has little therapeutic value in the management of these patients. With culture and sensitivity tests costing £25 - £30, omission of this practice in the case of uncomplicated (single tissue space) odontogenic infections could save resources in the National Health Service without affecting the care of patients.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Drainage; Female; Follow-Up Studies; Humans; Infant; Length of Stay; Male; Metronidazole; Middle Aged; Retrospective Studies; Smoking; Streptococcal Infections; Tooth Diseases; Viridans Streptococci; Young Adult

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cholangiography; Cholecystectomy; Cholecystectomy, Laparoscopic; Cholecystitis, Acute; Choledocholithiasis; Endoscopy, Gastrointestinal; Female; Humans; Male; Postoperative Complications

Bacterial resistance to antibiotics is a health problem in many parts of the world. The aim of this study was to identify bacteria from dental infections and determine bacterial resistance to antibiotics used in dental care in the primary dentition.. This cross-sectional study comprised 60 children who presented for dental treatment for active dental infections in the primary dentition. Samples from dental infections were collected and bacteria were identified by polymerase chain reaction (PCR) assay. Bacterial resistance to antibiotics was determined by colony forming units on agar plates containing amoxicillin, clindamycin and amoxillicin-clavulanic acid (A-CA) tested at 8 μg/ml or 16 μg/ml.. Clindamycin in both concentrations tested (8 μg/ml and 16 μg/ml) showed the highest bacterial resistance (85.9%), followed by amoxicillin (43.7%) and A-CA (12.0%). All comparisons among the three antibiotics used in the study exhibited statistical significance (p = <0.05) in both concentrations tested (8 μg/ml and 16 μg/ml), and under aerobic and anaerobic conditions. The most prevalent resistant species identified by PCR in primary dentition infections were: Streptococcus oralis and Prevotella intermedia (75.0%); Treponema denticola and Porphyromonas gingivalis (48.3%); Streptococcus mutans (45.0%); Campylobacter rectus; and Streptococcus salivarius (40%).. This study demonstrated that A-CA exhibited the lowest bacterial resistance for clinical isolates in primary dentition infections.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Biofilms; Child; Child, Preschool; Clindamycin; Colony Count, Microbial; Cross-Sectional Studies; Dental Plaque; Drug Resistance, Multiple, Bacterial; Humans; Tooth Diseases; Tooth, Deciduous

Topics: Administration, Oral; Administration, Topical; Adrenal Cortex Hormones; Amoxicillin-Potassium Clavulanate Combination; Bacitracin; Bacterial Infections; Child, Preschool; Colistin; Germany; Humans; Hydrocortisone; Middle Ear Ventilation; Otitis Media, Suppurative; Postoperative Complications; Randomized Controlled Trials as Topic

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Cholecystectomy; Cholecystitis, Acute; Female; Humans; Male; Postoperative Complications

To update the American Academy of Pediatrics clinical practice guideline regarding the diagnosis and management of acute bacterial sinusitis in children and adolescents.. Analysis of the medical literature published since the last version of the guideline (2001).. The diagnosis of acute bacterial sinusitis is made when a child with an acute upper respiratory tract infection (URI) presents with (1) persistent illness (nasal discharge [of any quality] or daytime cough or both lasting more than 10 days without improvement), (2) a worsening course (worsening or new onset of nasal discharge, daytime cough, or fever after initial improvement), or (3) severe onset (concurrent fever[temperature ≥39°C/102.2°F] and purulent nasal discharge for at least 3 consecutive days). Clinicians should not obtain imaging studies of any kind to distinguish acute bacterial sinusitis from viral URI, because they do not contribute to the diagnosis; however, a contrast-enhanced computed tomography scan of the paranasal sinuses should be obtained whenever a child is suspected of having orbital or central nervous system complications. The clinician should prescribe antibiotic therapy for acute bacterial sinusitis in children with severe onset or worsening course. The clinician should either prescribe antibiotic therapy or offer additional observation for 3 days to children with persistent illness. Amoxicillin with or without clavulanate is the firstline treatment of acute bacterial sinusitis. Clinicians should reassess initial management if there is either a caregiver report of worsening(progression of initial signs/symptoms or appearance of new signs/symptoms) or failure to improve within 72 hours of initial management.If the diagnosis of acute bacterial sinusitis is confirmed in a child with worsening symptoms or failure to improve, then clinicians may change the antibiotic therapy for the child initially managed with antibiotic or initiate antibiotic treatment of the child initially managed with observation.. Changes in this revision include the addition of a clinical presentation designated as “worsening course,” an option to treat immediately or observe children with persistent symptoms for 3 days before treating, and a review of evidence indicating that imaging is not necessary in children with uncomplicated acute bacterial sinusitis.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Disease Progression; Female; Humans; Infant; Male; Observation; Paranasal Sinuses; Prognosis; Respiratory Tract Infections; Sinusitis; Tomography, X-Ray Computed; Treatment Outcome; United States

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Aza Compounds; Bacterial Infections; Female; Fluoroquinolones; Humans; Male; Moxifloxacin; Pulmonary Disease, Chronic Obstructive; Quinolines

Topics: Acute Disease; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Drug Therapy, Combination; Humans; Practice Guidelines as Topic; Rhinitis; Sinusitis; Treatment Outcome

To assess the quality of prescription of fluoroquinolons, aminosids and amoxicillin-clavulanic acids in medicine departments.. Data on target antibiotic prescription were collected on a given day and confronted to local recommendations and literature guidelines. Evaluation of antibiotic therapy was done by assessing molecule choice, administration conditions (dosages, route and administration schedule, treatment duration), reassessment of treatments 48-72 h later, dose adaptation of aminosids depending on serum monitoring.. Sixty-three patients were included and 67 "target" antibiotics were prescribed. Prevalence of antibiotic-treated patients was 24.4%, and 14.6% for "target" antibiotic-treated patients. Antibiotic choice was appropriate in 67% of prescriptions. Dosages were adequates in 94% of case and administration schedule in 97% of cases. The oral route administration as soon as possible was applied to half of patients. Treatment duration were respected for 94% of prescriptions. Reassessment of antibiotic therapy 48-72 h later was realized in 66% of cases. Dose adaptation of aminosids, when necessary, was realized on one third of cases. For all the quality criteria assessed, the overall frequency of prescription conformity was 44%.. Large diffusion of protocols, systematic reassessment of treatments at 48-72 h, promotion of training sessions for new prescribers in the institution, reinforcing the function of medical correspondents in antibiotic therapy and infectiologists, periodic evaluation of antibiotic therapy, should improve the quality of antibiotic therapy.

Topics: Aged; Aminoglycosides; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Drug Prescriptions; Female; Fluoroquinolones; France; Guideline Adherence; Hospital Departments; Hospital Records; Hospitals, Teaching; Humans; Male; Middle Aged; Practice Guidelines as Topic

Data on 13 years (1997-2009) of outpatient penicillin use were collected from 33 European countries within the European Surveillance of Antimicrobial Consumption (ESAC) project and analysed in detail.. For the period 1997-2009, data on outpatient use of systemic penicillins aggregated at the level of the active substance were collected using the Anatomical Therapeutic Chemical (ATC)/defined daily dose (DDD) method (WHO, version 2011) and expressed in DDD per 1000 inhabitants per day (DID). For detailed analysis of trends over time, seasonal variation and composition of outpatient penicillin use in 33 European countries, we distinguished between narrow-spectrum penicillins (NSP), broad-spectrum penicillins (BSP), penicillinase-resistant penicillins (PRP) and combinations with β-lactamase inhibitors (COP).. Total outpatient penicillin (ATC group J01C) use in 2009 varied by a factor of 3.8 between the countries with the highest (16.08 DID in France) and lowest (4.23 DID in the Russian Federation) use. COP represented 45.8%, BSP 40.7%, NSP 10.8% and PRP 2.6% of total European outpatient penicillin use. Total outpatient penicillin use significantly increased over time by 1.53 (SD 0.71) DID between 1997 and 2009. COP (mainly co-amoxiclav) increased by 2.17 (SD 0.40) DID, which was the result of its absolute increase as well as the observed shift from NSP and BSP towards COP. This increase exceeded 10% in 20 countries, where it coincided with a similar decrease in either BSP (15 countries) or NSP (5 countries).. Penicillins represented the most widely used antibiotic subgroup in all 33 participating countries, albeit with considerable variation in their use patterns. For Europe, a continuous increase in overall penicillin use and of COP use was observed during the period 1997-2009.

Topics: Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Drug Utilization; Europe; Humans; Outpatients; Penicillins; Pharmacoepidemiology; Seasons; Statistics as Topic

The in vitro activities of ceftaroline, a novel, parenteral, broad-spectrum cephalosporin, and four comparator antimicrobials were determined against anaerobic bacteria. Against Gram-positive strains, the activity of ceftaroline was similar to that of amoxicillin-clavulanate and four to eight times greater than that of ceftriaxone. Against Gram-negative organisms, ceftaroline showed good activity against beta-lactamase-negative strains but not against the members of the Bacteroides fragilis group. Ceftaroline showed potent activity against a broad spectrum of anaerobes encountered in respiratory, skin, and soft tissue infections.

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria, Anaerobic; Bacterial Infections; Bacteroides fragilis; Ceftaroline; Ceftriaxone; Cephalosporins; Drug Resistance, Bacterial; Gram-Negative Aerobic Bacteria; Gram-Positive Bacteria; Humans; In Vitro Techniques; Microbial Sensitivity Tests

Tonsillectomy is the most common surgery performed in the pediatric and young adult populations. Although recent guidelines based on meta-analysis suggest that perioperative chemoprophylaxis plays a role in reducing bacteraemia-related post-tonsillectomy complications, there is no evidence or agreement upon which specific antibiotic, dosage or administration route should be preferred. Since few previous studies have assessed the effectiveness of prophylaxis by direct measurement of antibiotic levels both in plasma and tissue, we designed an experimental study to quantitatively evaluate amoxicillin concentrations in children ready for tonsillectomy and compare these plasma and tissue levels with the Minimal Inhibitory Concentrations (MIC) of the bacteria more commonly involved in the upper airway infections.. Thirty-three pediatric patients under 14 years of age (median 5.0, IQR 4-7, range 3-11; M:F 18:15) with recurrent tonsillitis were treated with 3 doses (established on patient's weight) of amoxicillin-clavulanic acid given orally the day before plus a further dose 2h before tonsillectomy. Amoxicillin concentrations on both homogenated tonsillar cores and plasma were measured by HPLC-UV. Bacterial epidemiology and susceptibility were derived respectively from survey data collected by Microbiology Unit and MIC according to the National Committee for Clinical Laboratory Standards (NCCLS).. Median plasma and tissue amoxicillin concentrations were respectively 4.7 microg/ml (IQR 2.1-8.0; min-max 0.4-14.3) and 1.1 microg/g (IQR 0.4-2.1; min-max 0.4-12.9), considerably below the selected target MIC of pathogens involved in the upper respiratory tract infections (S. aureus, H. influenzae, M. catarrhalis). 20 Children showed undetectable amoxicillin levels in one or both tonsils. Interestingly, 7 out of these patients (35%) had plasma concentrations higher than the target MIC (8 microg/ml). No patient displayed plasma concentrations under the limit of sensitivity of the method. Poor core-plasma and left-right core correlation was observed among patients, suggesting that fibrosis developed after recurrent tonsillitis may hamper antibiotic penetration.. Based upon direct measurement of antibiotic levels in plasma and tissue, this study suggests that a revision of the oral prophylaxis in children is required in order to reduce microbial charge in the operative field and accordingly improve the recovery after tonsillectomy.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Bacterial Infections; Child; Child, Preschool; Chromatography, High Pressure Liquid; Female; Humans; Male; Microbial Sensitivity Tests; Palatine Tonsil; Postoperative Complications; Tonsillectomy

Topics: Aged; Amoxicillin-Potassium Clavulanate Combination; Anorexia; Anti-Bacterial Agents; Bacterial Infections; Gastric Outlet Obstruction; Humans; Male; Parotitis; Treatment Outcome; Weight Loss

The aim of this study was to assess the clinical effect of antibiotic treatment in a cohort of patients with low-back pain (LBP) and Modic changes Type 1 (bone oedema) following a lumbar herniated disc.. This was a prospective uncontrolled trial of 32 LBP patients who had Modic changes and were treated with Amoxicillin-clavulanate (500 mg/125 mg) 3 x day for 90 days. All patients had previously participated in a randomised controlled trial (RCT) that investigated active conservative treatment for a lumbar herniated disc (n = 166). All patients in that RCT who had Modic changes and LBP at 14 months follow-up (n = 37) were invited to participate in this subsequent antibiotic trial but five did not meet the inclusion criteria.. 29 patients completed the treatment, as three patients dropped out due to severe diarrhoea. At the end of treatment and at long-term follow-up (mean 10.8 months) there was both clinically important and statistically significant (p

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Bone Marrow Diseases; Edema; Female; Humans; Intervertebral Disc Displacement; Low Back Pain; Male; Middle Aged; Pilot Projects; Prospective Studies; Treatment Outcome

The empiric choice of initial antibiotherapy in osteoarticular infections in infants and children must take into consideration the actual epidemiology of principal pathogens, their respective antibiotic sensitivity profile, their pharmacokinetic and pharmacodynamic properties and the results of efficacy clinical studies. After a review of recent data concerning these four major points, the Paediatric Infectious Diseases Group of the French Society of Paediatrics (GPIP) has proposed guidelines for initial recommended schemes of antimicrobial therapy in acute and non complicated osteoarticular infections in infants and children.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Bone Diseases, Infectious; Child; Community-Acquired Infections; Cross Infection; Drug Resistance, Bacterial; Fluoroquinolones; Humans; Infant; Joint Diseases; Kingella kingae; Methicillin Resistance; Methicillin-Resistant Staphylococcus aureus; Neisseriaceae Infections; Penicillins; Pneumococcal Infections; Pristinamycin; Rifampin; Staphylococcal Infections; Staphylococcus aureus; Treatment Outcome

The nasal septum abscess is a rare and serious infection because of the complications which can be generated. The authors report a new case of nasal septum abscess to probably from dental origin.. A 47 year old man consulted for bilateral nasal obstruction and rhinorrhea for 3 days with an infectious context. The clinical examination as well as the CT scan demonstrated a septal abscess. The patient had a surgical drainage associated with a triple antibiotherapy with favourable evolution at the end of 10 days. The etiologic investigation is in favour of a dental etiology.. It is about a rare and serious infectious pathology of the nasal septum. We point out its various etiologies, its management, while insisting on the preventive treatment of this affection.

Topics: Abscess; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bacterial Infections; Cerebrospinal Fluid Rhinorrhea; Humans; Magnetic Resonance Imaging; Male; Middle Aged; Nasal Septum; Tomography, X-Ray Computed

The objective of this investigation was to assess retrospectively the safety and the efficacy of oral ciprofloxacin plus cefuroxime axetil compared to the combination of oral ciprofloxacin plus amoxicillin/clavulanate, as initial outpatient treatment, in low-risk cancer patients with fever and neutropenia. We analysed retrospectively 120 episodes of febrile neutropenia, treated on an outpatient basis at 2 different oncology units; 63 episodes were treated with the oral regimen of ciprofloxacin plus amoxicillin/clavulanate and 57 were treated with the combination of oral ciprofloxacin plus cefuroxime. 20 treatment failures were recorded-2 of them among patients receiving ciprofloxacin plus amoxicillin/clavulanate and 18 in the ciprofloxacin plus cefuroxime group. Univariate analysis showed that the administration of ciprofloxacin plus cefuroxime was associated with a worse outcome compared to the regimen ciprofloxacin plus amoxicillin/clavulanate (OR 11, CI 2.42-49.9, p =0.002). In the multivariate model, after adjusting for the absolute number of neutrophils and the duration of neutropenia, the effect of the antibiotic regimen on the outcome disappeared, and no significant differences between the 2 regimens were noted, although the regimen of ciprofloxacin plus cefuroxime was associated with a trend to a worse outcome (OR 4.74, CI 0.72-31.1, p =0.10). In conclusion, the 2 regimens appeared equally safe and effective but prospective studies are needed to confirm these results.

Topics: Administration, Oral; Adult; Aged; Ambulatory Care; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bacterial Infections; Cefuroxime; Ciprofloxacin; Drug Therapy, Combination; Female; Fever; Humans; Male; Middle Aged; Neoplasms; Neutropenia; Retrospective Studies

We recommend amoxacillin/clavulanate, cephalosporins and macrolides rather than penicillin as the first-line drug in chronic sinusitis with nasal polyps. In cases where there is no improvement of symptoms, cultures should be taken from the middle meatus, followed by appropriate selection of second-line antibiotics according to the sensitivity test results.. To investigate the causative bacteria and the antimicrobial susceptibility in patients with chronic sinusitis and nasal polyps in Korea.. The bacteriology and antimicrobial susceptibility of maxillary sinus aspirates from 81 patients were evaluated.. Aerobes were isolated from 58.0% of the cultures from the middle meatus and from 48.1% of those from the maxillary sinus. Staphylococcus aureus, Haemophilus influenzae, and Streptococcus pneumoniae were the most prevalent aerobic pathogens. Anaerobes were isolated from 8.6% of the cultures from the middle meatus and from 18.5% of the cultures from the maxillary sinus. The predominant anaerobic organisms were Prevotella and Peptostreptococcus in adults but none of them were cultured in children. A high rate of concordance of the middle meatus and maxillary sinus was noted. Monomicrobial infection was most commonly observed. Ampicillin-resistant H. influenzae isolates were cultured in 46% of the cases. Penicillin resistance rates were 93% for Staph. aureus; 25% of Strep. pneumoniae were intermediate and 25% were resistant.

Topics: Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bacteria, Anaerobic; Bacterial Infections; Bacteriological Techniques; Cephalosporins; Child; Chronic Disease; Female; Haemophilus Infections; Humans; Macrolides; Male; Maxillary Sinus; Maxillary Sinusitis; Microbial Sensitivity Tests; Nasal Mucosa; Nasal Polyps; Penicillin Resistance; Pneumococcal Infections; Staphylococcal Infections; Statistics as Topic; Treatment Outcome

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Ceftazidime; Ciprofloxacin; Humans; Immune Tolerance; Neoplasms; Opportunistic Infections; Practice Guidelines as Topic; Pseudomonas Infections

The growing resistance of Streptococcus pneumoniae to penicillin can be overcome by increasing the dose of the penicillin administered. This generated the recommendation that the adult dose of amoxicillin for the treatment of acute maxillary sinusitis (AMS) be increased from 1.5 g/day to 4.0 g/day. The objective of this study was to investigate whether the higher dose of amoxicillin is more effective than the previously recommended dose in eradicating S. pneumoniae from the nasopharynx of patients who present with AMS. Nasopharyngeal cultures obtained from 58 patients with AMS were studied: 30 received amoxicillin 1.5 g/day given in divided doses three times a day for 10 days (amoxicillin/clavulanic acid 4:1 formulation) and 28 were treated with amoxicillin 4.0 g/day given in divided doses twice a day for 10 days (amoxicillin/clavulanic acid 16:1 formulation). Seventy-one potentially pathogenic organisms were isolated: S. pneumoniae (27 isolates), Haemophilus influenzae non-type b (25), Moraxella catarrhalis (5), Streptococcus pyogenes (5) and Staphylococcus aureus (9). The number of S. pneumoniae isolates in the 1.5 g/day group was reduced from 14 to 9 (2 intermediately resistant and 3 highly resistant). In contrast, the number of S. pneumoniae isolates in the 4.0 g/day group was reduced from 13 to 2 (1 highly resistant) (P<0.05). No differences were noted in the eradication rate of other groups of isolates, which were all susceptible to amoxicillin/clavulanic acid. These data illustrate the superiority of 4.0 g/day amoxicillin/clavulanic acid compared with 1.5 g/day amoxicillin/clavulanic acid in the eradication of S. pneumoniae from the nasopharynx.

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Dose-Response Relationship, Drug; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Male; Maxillary Sinusitis; Middle Aged; Moraxella catarrhalis; Moraxellaceae Infections; Nasopharynx; Pneumococcal Infections; Staphylococcal Infections; Streptococcal Infections; Streptococcus pyogenes

In vitro susceptibility data were collected for co-amoxiclav and other antimicrobial agents against 1297 recent anaerobe isolates collected in Europe and the USA. The co-amoxiclav (amoxicillin/clavulanic acid) MIC(50/90)s (amoxicillin/clavulanic acid concentration in a ratio of 2:1, expressed in terms of amoxicillin concentration in mg/L) were 0.5/4 for Bacteroides fragilis, 96% susceptible) except E. corrodens (MIC(50/90) of >32/>64 mg/L), which is a capnophilic organism. Imipenem was also highly active against all species (>98% susceptible). Levofloxacin and clindamycin were the least potent agents tested, particularly against Bacteroides, Prevotella and Peptostreptococcus (levofloxacin susceptibility rates: Bacteroides 72.7%, Prevotella 71.5%, F. magna 72.4%; clindamycin susceptibility rates: Bacteroides 79.5%, Prevotella 92.1%, F. magna 84.7%).

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Infective Agents; Bacteria, Anaerobic; Bacterial Infections; beta-Lactamases; Carbon Dioxide; Drug Resistance, Bacterial; Drug Therapy, Combination; Europe; Humans; Microbial Sensitivity Tests; Population Surveillance; Quality Control; United States

The present study was conducted to determine the in vitro activity of amoxicillin-clavulanic acid compared to that of four newer antimicrobial agents (ampicillin, azithromycin, cefuroxime and trimethoprim-sulfamethoxazole). All of the agents were tested against 21232 recent clinical isolates encompassing 37 species submitted from 16 European countries between 1997 and 1999. After 20 years of clinical use, amoxicillin-clavulanic acid continues to retain much of its initial activity against targeted gram-positive organisms, selected gram-negative organisms and major respiratory pathogens.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Cefuroxime; Gram-Negative Bacteria; Gram-Positive Bacteria; Humans; Microbial Sensitivity Tests; Trimethoprim, Sulfamethoxazole Drug Combination

The in vitro activity of amoxycillin-clavulanic acid was compared with four comparator oral antimicrobial agents; ampicillin, azithromycin, cefuroxime and trimethoprim-sulphamethoxazole against 4536 recent clinical isolates covering 29 species isolated in the US and Canada between 1997 and 1999. Based upon Minimum inhibitory concentrations (MICs), amoxycillin-clavulanic acid was the most active agent against many Gram-positive species and phenotypes including methicillin susceptible Staphylococcus aureus (MSSA) Staphylococcus epidermidis, Enterococcus faecalis, Streptococcus pyogenes, Streptococcus pneumoniae including penicillin intermediate and macrolide resistant strains and was as active as ampicillin against Streptococcus agalactiae, penicillin resistant S. pneumoniae and viridans streptococci. Against Enterobacteriaceae amoxycillin-clavulanic acid in general, displayed weak activity with only Proteus mirabilis and Proteus vulgaris displaying levels of susceptibility above the 90th percentile. Amoxycillin-clavulanic acid had significant activity against many species of Gram-negative non-Enterobacteriaceae including Haemophilus influenzae, Haemophilus parainfluenzae and Moraxella catarrhalis but negligible activity against Burkholderia cepacia, Pseudomonas aeruginosa and Stenotrophomonas maltophilia. Amoxycillin-clavulanic acid continues to retain excellent activity against the majority of targeted pathogens despite 20 years of clinical use.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Drug Resistance, Bacterial; Humans; Microbial Sensitivity Tests; North America

Topics: Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Drug Therapy, Combination; Humans; Peritonitis

Topics: Acute Disease; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Drug Administration Schedule; Humans; Sinusitis; Treatment Outcome

Sparse recent data are available in the United States regarding the pathogens of acute otitis media (AOM) most likely to be recovered from children recently treated with the two most frequently prescribed antibiotics, amoxicillin or amoxicillin/clavulanate (AMC).. Of the 704 rural Kentucky children with culture-positive AOM who underwent a single tympanocentesis or culture of otorrhea between 1992 and 1998, 96 pathogens were recovered from 90 children during therapy or within 7 days posttherapy with an aminopenicillin. Identification and susceptibility testing of AOM pathogens were performed by routine National Committee for Clinical Laboratory Standards methods.. Pathogens recovered from children with AOM recently treated (0 to 7 days) with amoxicillin (n = 38) and AMC (n = 58), respectively, were as follows: Haemophilus influenzae (beta-lactamase-negative), 16 and 29%; H. influenzae (beta-lactamase-positive), 11 and 22%; penicillin-susceptible Streptococcus pneumoniae, 26 and 12%; intermediately penicillin-nonsusceptible S. pneumoniae (PNSP), 20 and 10%; resistant PNSP 13 and 17%; Moraxella catarrhalis (beta-lactamase-positive), 13 and 7%; and Streptococcus pyogenes, 3 and 2%. H. influenzae was also isolated from 8 (75%) of 12 children treated with high dose AMC ( approximately 80 mg/kg/day amoxicillin component). Significantly fewer children recently treated with amoxicillin were otitis-prone than those given AMC (24% vs. 74%, P < 0.0001).. The predominant pathogen recovered from children with AOM recently treated with amoxicillin was S. pneumoniae (59%) rather than beta-lactamase-producing organisms (24%). H. influenzae was the predominant (51%) pathogen, rather than PNSP (27%), recovered from children recently treated with AMC.

Topics: Acute Disease; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; beta-Lactam Resistance; Child; Child, Preschool; Drug Resistance, Multiple, Bacterial; Drug Therapy, Combination; Female; Haemophilus influenzae; Humans; Infant; Male; Microbial Sensitivity Tests; Moraxella catarrhalis; Otitis Media with Effusion; Penicillins; Retrospective Studies; Streptococcus pneumoniae; Streptococcus pyogenes

Topics: Amoxicillin-Potassium Clavulanate Combination; Bacteria, Anaerobic; Bacterial Infections; Dental Implants; Drug Therapy, Combination; Humans; Male; Maxillary Sinus; Middle Aged; Odorants

To evaluate the palatability of antimicrobial agents effective against beta-lactamase-producing bacteria in American children.. In a taste test of 4 antimicrobial agents, azithromycin (cherry flavored), cefprozil (bubble gum flavored), cefixime (strawberry flavored), and amoxicillin-clavulanic acid (banana flavored) were compared.. An urban inner-city primary care clinic.. A volunteer sample of 30 healthy children (aged 5-8 years).. Palatability was determined using a single-blind taste test of 4 flavored antimicrobial agents. The 4 antimicrobial agents used were azithromycin, cefprozil, cefixime, and amoxicillin-clavulanic acid.. After each antimicrobial test dose, subjects rated the taste on a 10-cm visual analog scale incorporating a facial hedonic scale. Preference assessments for the best-tasting and worst-tasting agent were also conducted.. Of the 20 children who expressed a preference, significantly more children (9 [45%], P<.05) selected the cefixime preparation as the best-tasting formulation compared with the other preparations. The cefixime preparation was also significantly the least likely to be selected as the worst-tasting preparation (2 [10%], P<.05). There were no significant differences between the other 3 preparations with respect to being selected as either the best or worst tasting. The mean (+/- SD) visual analog scale score for cefixime was highest (8.53 [2.49]) compared with the scores for azithromycin (6.78 [3.45]), cefprozil (6.26 [4.04]), and amoxicillin-clavulanic acid (6.24 [4.01]).. The cefixime preparation was most commonly rated as best tasting by children.

Topics: Administration, Oral; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Azithromycin; Bacterial Infections; Cefixime; Cefprozil; Cephalosporins; Child; Child, Preschool; Female; Flavoring Agents; Humans; Male; Pain Measurement; Patient Acceptance of Health Care; Taste; Urban Population

The results of an observational study of amoxicillin/clavulanic acid (Augmentan) in 191 patients are presented. The average duration of treatment was 15 days (median). Healing or improvement was observed in 76% of the cases. In view of the fact that the condition often has a multifactorial genesis and neural and vascular changes impair healing, this result must be considered a clinical success. Variables with an influence on the efficacy of the treatment were the incidence of manifestation and pathogenesis of the ulcer, renal function, blood pressure and smoking. Amoxicillin/clavulanic acid was well tolerated, with adverse events being observed in only 9 out of 193 patients (4.7%). Treatment was abandoned because of adverse events in 3 out of 193 patients (1.6%). Overall, treatment of the infected diabetic foot with amoxicillin/clavulanic acid was well tolerated and effective.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Diabetic Foot; Female; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Treatment Outcome

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Dose-Response Relationship, Drug; Humans; Respiratory Tract Infections

Topics: Administration, Oral; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Dose-Response Relationship, Drug; Drug Administration Schedule; Humans; Infant; Microbial Sensitivity Tests; Respiratory Tract Infections

The objective of this report was to document the pattern of initial antibiotic prescribing in acute exacerbations of chronic obstructive pulmonary disease (COPD) in a hospital setting. All episodes of acute exacerbation of COPD, as diagnosed by the admitting doctor, in one hospital in the period January to May 1996, were identified. Case notes were reviewed retrospectively. Cases of radiographic pneumonia, bronchiectasis and incorrectly coded admissions were excluded. Symptoms, microbial cultures and initial antibiotic therapies were recorded. One hundred and fifty-nine patient episodes were identified; 40 were excluded yielding a sample of 119. Nineteen case notes were unavailable leaving a sample of 100 (84%) episodes. Eighty were treated with antibiotics on admission; amoxycillin was the most frequently prescribed, in 46 (58%) episodes. Of the antibiotic treated group, 42 (53%) patients were given dual therapy, most commonly a macrolide antibiotic with either amoxycillin or a cephalosporin. Intravenous treatment was used in 22 (28%) cases. The duration of intravenous treatment was >48 h in 12 (15%) cases. A total of 76 sputum samples were analysed from 55 patient episodes: 34 (45%) were culture positive. In 15 (27%) patient episodes, antibiotic therapy was changed or instituted on the basis of culture results. These data suggest that antibiotic treatment is not optimal, with overuse of antibiotics, especially intravenous and dual therapy.

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Case-Control Studies; Drug Therapy, Combination; Drug Utilization Review; Female; Humans; Lung Diseases, Obstructive; Male; Penicillins; Retrospective Studies; Tetracycline

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Chemistry, Pharmaceutical; Child, Preschool; Cross Infection; Dosage Forms; Humans; Infection Control

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Diabetic Foot; Dose-Response Relationship, Drug; Drug Therapy, Combination; Female; Humans; Male; Treatment Outcome

The antimicrobial susceptibility of 1078 isolates of Haemophilus influenzae, 348 Streptococcus pneumoniae and 258 Moraxella catarrhalis was determined. Overall 15.1% of H. influenzae produced beta-lactamase; 98.8% were susceptible to co-amoxiclav, 85.8% to cefaclor, 96% to clarithromycin and 100% to ciprofloxacin. The majority (94.2%) of M. catarrhalis produced beta-lactamase. The overall prevalence of low-level penicillin resistance (MIC = 0.12-1 mg/L) amongst isolates of S. pneumoniae was 3.4% and that of high-level resistance (MIC > or = 2 mg/L) was 3.7%. Most (96.3%) of the isolates of S. pneumoniae were susceptible to amoxycillin (MIC < or = 0.5 mg/L), 96% to cefaclor (MIC < or = 8 mg/L), 90.7% to clarithromycin (MIC < or = 0.25 mg/L) and 89% to ciprofloxacin (MIC < or = 1 mg/L).

Topics: Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Ampicillin Resistance; Anti-Bacterial Agents; Bacteria; Bacterial Infections; beta-Lactam Resistance; beta-Lactamases; Cefaclor; Cephalosporins; Ciprofloxacin; Clarithromycin; Common Cold; Community-Acquired Infections; Dose-Response Relationship, Drug; Haemophilus influenzae; Humans; Microbial Sensitivity Tests; Moraxella catarrhalis; Multicenter Studies as Topic; Penicillins; Respiratory System; Respiratory Tract Infections; Streptococcus pneumoniae; United Kingdom

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Humans

Topics: Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria, Anaerobic; Bacterial Infections; Community-Acquired Infections; Drug Therapy, Combination; Empyema, Pleural; Humans; Lung Abscess; Lung Diseases, Obstructive; Microbial Sensitivity Tests; Pleurisy; Pneumonia, Bacterial; Respiratory Tract Infections

Amoxycillin-clavulanate was used in prophylaxis of infectious complications after abdominal hysterectomy. A group of 29 patients was treated routinely with metronidazol introduced vaginally 2-3 days before surgery. This group was compared with 40 patients who received two perioperative doses of Augmentin intravenously. The incidence of febrile morbidity, urinary tract infection, following antibiotic treatment and pelvic infection were followed in both groups. Patients in the amoxycillin-clavulanic acid group had significantly less infectious morbidity than those in the metronidazol group. The results suggest that antibiotic prophylaxis for abdominal hysterectomy is effective. The prophylactic agent should be bactericide against aerobic and anaerobic bacteria and non-toxic. Amoxycillin-clavulanate (Augmentin) meets all these criteria.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Antibiotic Prophylaxis; Bacterial Infections; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Hysterectomy; Middle Aged; Postoperative Complications

In a retrospective study, the clinical and microbiological efficacy of amoxycillin-clavulanic acid and ciprofloxacin were evaluated in outpatients observed within the previous year who were affected by acute purulent exacerbations of chronic bronchitis. Of the 95 patients included in the trial, 50 received amoxycillin 875 mg-clavulanic acid 125 mg 8-hourly for 10 days and 45 received ciprofloxacin 500 mg 12-hourly before meals for 10 days. Of the amoxycillin-clavulanic acid-treated patients, 90% showed clear clinical improvement and in 10% treatment failed. In the ciprofloxacin group, 75.5% of patients showed improvement and in 24.5% treatment failed. All pathogens isolated prior to therapy were susceptible to the antibiotic used for therapy. At the end of treatment, in the amoxycillin-clavulanic acid-treated group, 84% of strains were eradicated and 8% persisted; others were superinfections. In the ciprofloxacin group, 57.7% of strains were eradicated, 26.6% persisted and 15.5% were superinfections. No clinically significant side effects were observed in either group. Overall, amoxycillin-clavulanic acid demonstrated superior clinical and microbiological efficacy to ciprofloxacin, although this might be attributable to the higher proportion of aerobic Gram-negative pathogens in the ciprofloxacin group.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Bronchitis; Chronic Disease; Ciprofloxacin; Clavulanic Acids; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Retrospective Studies

30 patients with recurrent tonsillitis were treated with amoxycillin/clavulanic acid (500 mg/125 mg) t.i.d. for 10 days. The most often isolated potential aerobic pathogenic bacteria were Staphylococcus aureus, Streptococcus milleri and Haemophilus parainfluenzae. Group A streptococci were isolated from 7 patients. Anaerobic cocci and Bacteroides species were the dominating anaerobic bacteria isolated from the tonsils. Tonsillar cultures were taken before antibiotic treatment started, on days 11-12, day 30, and day 90. Beta-lactamase producing aerobic and anaerobic bacteria were present in 13 patients prior to treatment, on days 11-12 in 18 patients, on day 30 in 15 patients, and on day 90 in 13 patients. Group A streptococci were eradicated in 6/7 patients. In the aerobic tonsillar microflora, the numbers of viridans streptococci decreased during treatment but were normalized after 30 days. Only minor changes in the numbers of other aerobic microorganisms occurred during the investigation. The effect on the anaerobic microflora was minor and no new colonizing microorganisms were isolated during or after antibiotic treatment. All patients except one were cured on days 11-12. Five patients had another episode of tonsillitis during the observation period of 3 months. The antibiotic treatment was well tolerated in most patients and mild adverse events such as nausea, vomiting and diarrhoea were observed in 3 patients.

Topics: Adolescent; Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria, Aerobic; Bacteria, Anaerobic; Bacterial Infections; Clavulanic Acids; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Male; Recurrence; Tonsillitis

Spontaneous bacterial peritonitis in cirrhosis is a serious complication that demands urgent attention. We report here a prospective study of the treatment of 27 episodes of spontaneous bacterial peritonitis in 22 cirrhotic patients with amoxicillin and clavulanic acid. The infection of ascitic fluid was diagnosed by a positive culture plus an ascitic neutrophil count exceeding 75/microliters, or by an ascitic neutrophil count exceeding 500/microliters. The infection was treated with 1 gm amoxicillin and 0.2 gm clavulanic acid every 6 hr for 14 days. In 17 cases (63%), bacteria were isolated from the ascitic fluid. All the bacteria isolated were sensitive to amoxicillin and clavulanic acid, whereas in five cases they were resistant to amoxicillin alone (Escherichia coli in two cases, Klebsiella pneumoniae in two cases and Bacteroides fragilis in one case). Cure of the infection was achieved in 23 episodes (85%) after 14 days' treatment; 17 patients (63%) were able to leave the hospital. Fourteen of 20 patients (70%) treated for the first episode of infection died within 1 yr: eight from infection, two from gastrointestinal hemorrhage, one from infection and hemorrhage and three from tumors. One patient who had repeated infections underwent liver transplantation and has not had any infectious complications 1.5 yr after surgery. Amoxicillin and clavulanic acid may be an effective first-line therapy for ascitic fluid infection in cirrhosis. Nevertheless, the 1-yr prognosis continues to be grave and the severity of the underlying liver disease remains the most important determinant for survival.

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Drug Therapy, Combination; Humans; Liver Cirrhosis; Liver Cirrhosis, Alcoholic; Middle Aged; Peritonitis; Prognosis; Prospective Studies

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Female; Humans; Male; Middle Aged; Mouth Diseases; Periodontal Abscess

Topics: Adolescent; Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Female; Humans; Male; Microbial Sensitivity Tests; Middle Aged; Otitis; Pharyngitis; Rhinitis; Sinusitis; Tonsillitis

Topics: Adult; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Ciprofloxacin; Family Practice; Female; Humans; Male; Treatment Outcome; Urinary Tract Infections

Topics: Adult; Aged; Aged, 80 and over; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Antibiotic Prophylaxis; Bacterial Infections; Cefoxitin; Female; Humans; Male; Middle Aged; Perioperative Care; Randomized Controlled Trials as Topic; Vascular Surgical Procedures

A prospective study was carried out in 43 hospitalized patients with respiratory or other serious bacterial infections requiring intravenous antibiotic therapy to assess the efficacy and tolerance of amoxycillin/clavulanic acid ('Augmentin'). After bacteriological and laboratory investigations patients were started on 1 g amoxycillin plus 200 mg clavulanic acid intravenously every 8 hours for the first 3 days and then were treated orally at the same dosage. Duration of treatment varied according to the type and severity of the infection, with a minimum of 10 days. Efficacy of treatment was evaluated by the clinical response, judged by the resolution of signs and symptoms of infection. The results showed that there was a clinical cure rate of 88.4%. Local tolerance was excellent and there were few side-effects reported. Six patients experienced vomiting which led to the withdrawal of treatment in 1 patient.

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Drug Therapy, Combination; Female; Humans; Injections, Intravenous; Male

Twenty patients, all admitted to hospital with acute purulent exacerbations of chronic bronchitis associated with Haemophilus influenzae, Streptococcus pneumoniae or beta-lactamase producing Branhamella catarrhalis were treated twice daily for ten days with amoxycillin/clavulanate. Ten patients were first given 1000 mg amoxycillin with 200 mg potassium clavulanate intravenously bd for three days, before crossing to the standard oral regimen of 1000 mg amoxycillin + 250 mg potassium clavulanate bd. Clinical results on day 10 were excellent in 16/20 patients, but 14 patients developed recurrences or reinfections within a week of the end-of-treatment, five of them with beta-lactamase producing B. catarrhalis. Bacteriological and kinetic studies showed that the branhamella beta-lactamases were inhibited by 0.25 mg/l clavulanic acid and that the mean sputum concentration of clavulanic acid was 0.16 mg/l, that of amoxycillin being 0.92 mg/l. The importance of the follow-up of such infections is stressed.

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; beta-Lactamase Inhibitors; Bronchitis; Chronic Disease; Clavulanic Acids; Drug Combinations; Female; Haemophilus Infections; Haemophilus influenzae; Humans; Kinetics; Male; Middle Aged; Moraxella; Recurrence; Sputum; Streptococcal Infections; Streptococcus pneumoniae

The efficacy and safety of intravenous and sequential intravenous-oral clavulanate-potentiated amoxycillin therapy was evaluated in 71 hospitalized paediatric patients, one month to 16 years of age. The infections treated included peritonsillar abscess (2 patients), purulent tracheitis (1), acute epiglottitis (24), pneumonia (31), pansinusitis (4), mastoiditis (1), cellulitis (4), lymphadenitis (2) and pyelonephritis (2). The severity of disease was rated as moderate in 31 patients (44%), and as severe in 40 (56%). Bacterial pathogens could be cultured in 26 cases (37%). The response to therapy was prompt and followed by clinical cure in each patient. Adverse drug effects included phlebitis (in 6%), mild gastrointestinal complaints (6%), rash (4%) and transient neutropenia and elevation of transaminases (one case each). It is concluded that amoxycillin/clavulanate is effective and safe treatment for bacterial infections of the respiratory tract, urinary tract, skin or soft tissues in children.

Topics: Administration, Oral; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Drug Combinations; Female; Humans; Infant; Injections, Intravenous; Male

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Drug Combinations; Humans; Penicillin Resistance; Surgical Wound Infection

Topics: Acute Disease; Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Clavulanic Acids; Cystitis; Drug Combinations; Female; Humans; Middle Aged; Pilot Projects

The in vitro susceptibilities of various causative organisms recently isolated from patients with genital infections to BRL 25000 (a formulation with 2 parts of amoxicillin and 1 part of potassium clavulanate), amoxicillin (AMPC), cefaclor (CCL), cephalexin (CEX), cefadroxil (CDX) and cefroxadine (CXD) were determined. beta-Lactamase-producing strains were detected by the nitrocefin disc method. Frequencies of isolation of beta-lactamase producing strains of E. coli, K. pneumoniae and B. fragilis were 36%, 96% and 100%, respectively. The activity of BRL 25000 against S. agalactiae and anaerobic GPC (anaerobic Streptococci, Peptostreptococcus spp.) was slightly less than that of AMPC but was 2- to 4-fold higher than CCL and 8- to 16-fold higher than CEX, CDX and CXD. Against E. coli and K. pneumoniae, the activity of BRL 25000 was superior to that of AMPC and approximately equal to CEX, CDX and CXD but 2-fold less than CCL. Against the B. fragilis group, BRL 25000 was much more active than AMPC or any of the cephalosporins tested, clearly demonstrating the beta-lactamase inhibitory properties of the clavulanic acid in BRL 25000. At inocula of 10(6) CFU/ml, MIC values of BRL 25000 were 12.5-50 micrograms/ml against some strains of E. coli, K. pneumoniae and B. fragilis. A mechanism of resistance other than beta-lactamase production is obviously prevalent in these strains. It is speculated that the resistance may be due to a low affinity of the drug to target proteins. Mixed infections of B. fragilis and E. coli or K. pneumoniae are commonly found in the obstetric and gynecological patients. BRL 25000 shows activity against these strains and also against both aerobic and anaerobic GPC. Therefore, BRL 25000 is considered useful for the treatment of genital infections.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacteria; Bacterial Infections; beta-Lactamases; Clavulanic Acids; Drug Combinations; Female; Genital Diseases, Female; Humans; Microbial Sensitivity Tests; Pregnancy; Pregnancy Complications, Infectious

The clinical efficacy of intravenous Augmentin (a formulation containing amoxycillin plus clavulanic acid) was investigated in an open study in fifty-eight children with a mean age of 6 years (range 1-15 years). The normal dosage was in the range 100-200 mg/kg/day Augmentin, administered parenterally by short i.v. infusion in 3 or 4 divided doses. Most patients were hospitalised for lower respiratory tract infections. Complete clinical cure or distinct clinical improvement was achieved in all assessable cases. Bacteriological success was obtained in 92% of the assessable cases. In two patients, mild, transient exanthema was noted after i.v. Augmentin was replaced by oral Augmentin. No additional therapeutic measures were required.

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Drug Combinations; Female; Humans; Infant; Infusions, Parenteral; Male; Penicillin Resistance; Respiratory Tract Infections; Urinary Tract Infections

Numerous beta-lactamase inhibitors have been developed to overcome the problems of bacterial resistance to beta-lactam antibiotics. One such agent, clavulanic acid, has been combined with amoxicillin, and the combination is effective against many amoxicillin-resistant organisms. Clinical studies have demonstrated the efficacy of amoxicillin/clavulanate in a variety of infections, however, comparative studies are few and have not demonstrated sufficiently the superiority of the combination over conventional antibiotic therapy. In addition, side effects appear to be more frequent than with amoxicillin alone. The place in therapy of amoxicillin/clavulanate is discussed.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; beta-Lactamase Inhibitors; Clavulanic Acid; Clavulanic Acids; Humans; Penicillanic Acid; Sulbactam

BRL 25000 granules, a formulation of amoxicillin (AMPC) and the beta-lactamase inhibitor clavulanic acid (CVA) in a ratio of 2 to 1, was studied clinically and bacteriologically in pediatric infections. The in vitro antibacterial activity of BRL 25000 was superior to AMPC against beta-lactamase producing strains. The pharmacokinetics of the BRL 25000 granule were studied following oral administration to a 6 years old female and 9 years old male in the fasting state at dose levels of 10 mg/kg and 16.1 mg/kg, respectively. In the case of the female dosed at 10 mg/kg, the peak serum concentrations were found to be 6.38 micrograms/ml for AMPC and 1.83 micrograms/ml for CVA at 1 hour following administration. The elimination half-life of AMPC was 0.86 hour and that of CVA was 0.67 hour. The 4-hour urinary recovery was 61.89% for AMPC and 17.92% for CVA. In the male receiving 16.1 mg/kg, the peak concentrations were 2.55 micrograms/ml for AMPC at 3 hours following administration and 1.46 micrograms/ml for CVA at 1.5 hours following administration. The elimination half-life of AMPC was 1.59 hours and that of CVA was 1.19 hours. The 6-hour urinary recovery was 44.19% for AMPC and 30.05% for CVA. In clinical studies, the BRL 25000 granule was administered to 36 infants with upper respiratory tract infections, mainly tonsillitis, urinary tract infections etc. Good clinical efficacy was obtained in 33/36 cases (91.7%). Diarrhea and rash were occasionally noted side effects but were not severe. From the above results, it can be concluded that the BRL 25000 granule is a suitable and effective drug for use in the treatment of pediatric infections.

Topics: Administration, Oral; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Male; Penicillin Resistance

Fundamental and clinical studies have been performed on the BRL 25000 granules (combination of amoxicillin (AMPC) and potassium clavulanate (CVA) in 2: 1 ratio) in the pediatric field. In bacteriological studies a potentiated antibacterial activity of BRL 25000 was recognized against AMPC-resistant and beta-lactamase producing clinical isolates. The pharmacokinetics of the BRL 25000 granules were studied at dose levels from 10 to 20 mg/kg. The peak serum concentrations of AMPC and CVA achieved approximately 1 hour after dosing were 4.29-9.55 micrograms/ml and 3.87-4.78 micrograms/ml, respectively. The serum half-life was found to be 0.90-1.31 hours for AMPC and 1.01-1.22 hours for CVA. Six-hour urinary excretion rates were 29.5-62.6% for AMPC and 12.6-37.9% for CVA. In the clinical studies, the BRL 25000 granules were administered to 36 pediatric patients (15 with upper and lower respiratory tract infections, 10 with urinary tract infections and 11 with skin or soft tissue infections, etc.) at dose levels of 30-50 mg/kg/day. Clinical results in all cases were excellent or good. In particular, good bacterial and clinical effects were obtained against infections caused by beta-lactamase producing AMPC-resistant strains except E. cloacae 1 strain. No adverse reactions or abnormal laboratory findings were recognized in any patient.

Topics: Administration, Oral; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Infant, Newborn; Male; Penicillin Resistance

BRL 25000, granules preparation containing 2 parts of amoxicillin (AMPC) and 1 part of clavulanic acid (CVA, beta-lactamase inhibitor) as its potassium salt, has been investigated fundamentally and clinically. An in vitro study of the antibacterial activity of BRL 25000 against clinically isolated S. aureus (34 strains) showed higher activity than for AMPC alone and demonstrated that CVA potentiated the activity of AMPC, showing a synergistic effect against beta-lactamase producing organisms. A total of 27 pediatric patients aged between 6 months and 13 years 8 months (23 with respiratory infections and 4 with urinary tract infections) were treated with a daily dose ranging from 31.7 to 54.5 mg/kg, divided into 3 or 4 doses a day for periods of 4-18 days. The clinical effect was evaluated as excellent in 26 cases, poor in 1 case and the efficacy ratio was therefore 96.3% (26/27). The bacteriological effect against 12 organisms isolated from 9 patients was studied and all were eradicated (12/12). A drug-related side effect was observed in only 1 patient who developed diarrhea on the 4th day of treatment which continued during the treatment for 10 days. However, no severe side effect and no abnormality related to the drug in laboratory findings were observed. From these results it is concluded that BRL 25000 will be a clinically effective drug in the treatment of mild and moderate infections in the pediatric field.

Topics: Administration, Oral; Adolescent; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Male; Penicillin Resistance; Staphylococcus aureus

Fundamental and clinical studies have been performed on BRL 25000 (clavulanic acid 1 part-amoxicillin 2 parts) granules in the pediatric field. The antibacterial activities of BRL 25000 and amoxicillin (AMPC) were investigated against clinically isolated and laboratory stocked strains. BRL 25000 was superior to AMPC against strains of E. coli, Salmonella sp. and Klebsiella sp., and similar against Gram-positive cocci. Serum concentrations of AMPC and clavulanic acid (CVA) were measured 0.25, 0.5, 1, 2, 4 and 6 hours after administration of BRL 25000 granules at dose levels of 7.5, 10, 15 and 20 mg/kg. At 7.5 mg/kg peak level of AMPC of 2.69 micrograms/ml was achieved about 2 hours after dosing with a biological half-life of 1.64 hours; corresponding value for CVA was 0.53 micrograms/ml at 1 hour with a T 1/2 of 1.46 hours. At 10 mg/kg, AMPC also peaked after 2 hours (3.82 micrograms/ml) and the T 1/2 was 1.63 hours, whilst for CVA the value was 0.56 micrograms/ml with a T 1/2 of 1.24 hours. Value for AMPC at 15 mg/kg was 5.18 micrograms/ml at 1 hour post dose with a T 1/2 of 1.48 hours, and for CVA 4.01 micrograms/ml at 1 hour with a T 1/2 of 0.89 hour. At the highest dose of 20 mg/kg, AMPC level reached 4.21 micrograms/ml after 2 hours with a T 1/2 of 2.39 hours, and the CVA peak was 1.64 micrograms/ml at 1 hour with a T 1/2 of 1.01 hours. The 6 hours urinary recovery of AMPC and CVA following administration of the BRL 25000 granules ranged from 38-64% and 2-33%, respectively. In the clinical studies, the BRL 25000 granules are administered to 15 cases with pediatric infections and the clinical response was excellent or good in all cases treated (100%). Bacteriological investigation was performed on 13 strains from 12 cases and all strains were eradicated (100%). Regarding side effects, elevation of eosinophil was observed in 1 case and vomiting in 3 cases.

Topics: Administration, Oral; Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Half-Life; Humans; Infant; Male; Penicillin Resistance

Fundamental and clinical studies on BRL 25000 granules were carried out in the pediatric field. BRL 25000 is a formulation comprising 1 part of clavulanic acid (CVA) and 2 parts of amoxicillin (AMPC). The MICs of BRL 25000 and AMPC were assessed against 24 clinically isolated strains of S. aureus (including 23 beta-lactamase producing strains), 22 S. pyogenes, 20 E. coli (8 beta-lactamase producing strains), 24 K. pneumoniae (24 beta-lactamase producing strains), 20 H. influenzae (6 beta-lactamase producing strains). BRL 25000 showed MIC80 (cumulatively 80% of strains were inhibited) at 6.25 micrograms/ml against S. aureus, less than or equal to 0.10 micrograms/ml against inst S. pyogenes, 12.5 micrograms/ml against E. coli, 6.25 micrograms/ml against K. pneumoniae and 0.39 micrograms/ml against H. influenzae. BRL 25000 showed no improvement in MIC terms against beta-lactamase nonproducing strains compared with AMPC. However, BRL 25000 was markedly more effective against beta-lactamase producing strains. Thus BRL 25000 was up to 8 fold more active against S. aureus, 2 to 64 fold against E. coli, 4 to 128 fold against K. pneumoniae, 4 to 16 fold against H. influenzae than AMPC. Following oral administration of BRL 25000 granules (at a dose level of 12.5 mg/kg) to 2 children aged 9 and 11 years, the mean peak serum concentrations of AMPC and CVA were 8.33 +/- 2.43 micrograms/ml and 4.44 +/- 1.65 micrograms/ml respectively 1 hour after dosing. The half-lives of AMPC and CVA were 1.35 +/- 0.42 hours and 0.91 +/- 0.05 hour, respectively. The urinary excretion was 48.21 +/- 3.83% for AMPC and 16.90 +/- 7.06% for CVA in the first 6 hours after administration. In clinical studies, 23 pediatric patients aged 2 months to 12 years with bacterial infections were treated with BRL 25000 granules and the clinical effectiveness, bacteriological response and side effects were evaluated. The clinical response was assessed in 23 cases, 3 with acute rhinitis, 6 with acute purulent tonsillitis, 5 with acute bronchitis, 4 with acute pneumonia, 3 with impetigo, 1 with furunculosis and 1 with periproctal abscess. Results were excellent in 13 cases, good in 7, fair in 3 and hence the efficacy rate (excellent and good cases) was 87.0% (20/23). In particular the clinical response in 9 cases with infections due to beta-lactamase producing organisms was excellent in 6, good in 2, fair in 1 and the efficacy rate was 88.9% (8/9).(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Half-Life; Humans; Infant; Male; Penicillin Resistance

Bacteriological and clinical evaluations of BRL 25000 (1 part clavulanic acid plus 2 parts amoxicillin) granules in the pediatric field have been performed. The MICs of BRL 25000 against 25 clinically isolated strains of S. aureus, 40 E. coli, and 14 K. pneumoniae were compared with those of AMPC. Against beta-lactamase non-producing strains of S. aureus and E. coli, the MICs of both drugs were nearly equal, however, against beta-lactamase producing strains of these species and K. pneumoniae, BRL 25000 was superior to AMPC. The blood levels of AMPC and CVA after single oral administration of approximately 15 mg/kg of BRL 25000 granules to fasted children were studied in 3 subjects. The mean levels of AMPC and CVA peaked about 1 hour after administration at values of 11.40 and 5.49 micrograms/ml, respectively, with half-lives of 0.91 and 1.02 hours, and AUCs of 23.52 and 12.66 hr X micrograms/ml, respectively. The 6-hour urinary recovery of AMPC ranged from 30.59% to 52.03% and for CVA from 16.31% to 45.18%. There was no significant difference between the blood level of AMPC following single oral administration of approximately 10 mg/kg AMPC granules and that of AMPC following single oral administration of approximately 15 mg/kg BRL 25000 granules to the same children. Clinical evaluation of BRL 25000 granules administered orally 3-4 times a day at total daily doses of between 42.9-52.9 mg/kg resulted in improvement, judged excellent or good, in all 7 cases of tonsillitis and 2 cases of pyelonephritis. In particular, the clinical effect was excellent in the case of tonsillitis where a beta-lactamase producing H. influenzae was isolated. In the total 11 cases treated, including 2 cases of mycoplasmal pneumonia excluded from the clinical evaluation, 1 case of rash and eosinophilia was observed. No other adverse reactions or abnormal laboratory findings were observed. The taste and flavor of the drug were well accepted by the children. It was concluded that BRL 25000 granules are promising new drug which should be markedly useful in the treatment of infections in pediatric outpatients.

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Male; Penicillin Resistance

BRL 25000 granules (containing 2 parts amoxicillin and 1 part clavulanic acid) have been studied fundamentally and clinically. The MICs of BRL 25000 against strains of S. aureus, E. coli, K. pneumoniae which were resistant to CEZ and beta-lactamase producing strains of H. influenzae were determined. The MICs of BRL 25000 at an inoculum of 10(6) cells/ml were 1/4 to 1/128 of those of AMPC and, in particular, the MICs of BRL 25000 were especially reduced against the organisms for which those of AMPC were more than 100 micrograms/ml. The pharmacokinetics of BRL 25000 were studied in 46 children at dose levels of 7.5 mg (8 fasting children, 7 non-fasting children), 10 mg/kg (4 fasting, 4 non-fasting), 15 mg/kg (4 fasting, 4 non-fasting), 20 mg/kg (8 fasting, 7 non-fasting). The peak serum concentrations in fasting children were marginally higher than those in non-fasting subjects. Values for AMPC and CVA from BRL 25000, dosed at 7.5, 10, 15 and 20 mg/kg to fasting children, 0.5-1 hour after dosing were 4.86 and 2.36 micrograms/ml, 5.20 and 1.69 micrograms/ml, 7.50 and 3.27 micrograms/ml, 9.38 and 6.30 micrograms/ml, respectively. In non-fasting subjects, corresponding values were 2.84 and 1.01 micrograms/ml, 4.53 and 2.10 micrograms/ml, 7.29 and 4.08 micrograms/ml, 6.83 and 2.96 micrograms/ml, respectively. The biological half-lives of AMPC and CVA, following the administration of BRL 25000, show no significant difference between the fasting and non-fasting states. Values for AMPC and CVA in fasting children were 0.85-1.15 hours and 0.64-1.03 hours, and in non-fasting children, 1.18-1.79 hours and 0.78-1.02 hours, respectively. The time to reach the peak serum concentration and half-lives were similar for AMPC and CVA when dosed as BRL 25000. Peak urinary concentrations for BRL 25000 (AMPC and CVA) at dose levels of 7.5, 10, 15, 20 mg/kg to fasting children were 681.8 and 148.2 micrograms/ml, 247.1 and 66.3 micrograms/ml, 484.2 and 149.1 micrograms/ml, 1,796.5 and 372.0 micrograms/ml, whilst in the non-fasting state the values were 496.3 and 83.2 micrograms/ml, 991.1 and 156.7 micrograms/ml, 2,397.5 and 460.7 micrograms/ml, 1, 896.3 and 323.4 micrograms/ml, respectively. The peak urinary concentration in the fasting state was observed at 0-2 hours after dosing, and in non-fasting individuals it occurred at 2-4 hours after dosing.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Kinetics; Male; Penicillin Resistance

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Animals; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Chemical Phenomena; Chemistry; Chemistry, Physical; Clavulanic Acids; Drug Combinations; Drug Stability; Female; Humans; Lethal Dose 50; Mice; Penicillin Resistance; Pregnancy; Rats

BRL 25000 is a preparation comprising 2 parts of amoxicillin (AMPC) to 1 part of clavulanic acid (CVA). Basic and clinical studies have been performed on BRL 25000 granules in the pediatric field. The antibacterial activities of BRL 25000 and AMPC against 48 strains of E. coli isolated from patients with urinary tract infections were studied. The MICs of BRL 25000 were all below 100 micrograms/ml, except for 1 strain with MIC greater than or equal to 800 micrograms/ml. However, 19 strains (40%) were resistant to AMPC, with MICs more than 800 micrograms/ml. BRL 25000 granules were administered to 23 children with bacterial infections and the clinical response was assessed as excellent in 10, good in 9, fair in 3, poor in 1, giving an overall efficacy rate of 83% (19/23). Isolated organisms were eradicated in 12 out of the 16 strains which were evaluated bacteriologically. Changes in intestinal bacterial flora following administration of BRL 25000 granules were studied in several children and decreases in flora were observed in some cases. No severe side effects were observed although three seemed to be a slightly higher incidence of diarrhea than with other drugs.

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Escherichia coli; Female; Humans; Infant; Intestines; Male; Penicillin Resistance

Laboratory and clinical studies on BRL 25000 granules (containing clavulanic acid (CVA) 1 part plus amoxicillin (AMPC) 2 parts) were performed in infections in the pediatric field. Following oral administration of BRL 25000 granules at a dose of 15 mg/kg body weight, the maximum serum levels of AMPC and CVA achieved approximately 1 hour after dosing were 8.68 micrograms/ml and 4.09 micrograms/ml and declined thereafter with half-lives of 1.39 and 0.80 hours, respectively. The 6-hour urinary recovery rates for AMPC and CVA were 55.81% and 26.08%, respectively. Following oral administration of BRL 25000 granules at a dose of 22.5 and 24.3 mg/kg body weight, the serum levels of AMPC and CVA peaked at 7.37 micrograms/ml and 2.98 micrograms/ml after 1 hour and declined with half-lives of 2.52 and 0.99 hours, respectively. The 6-hour urinary recovery rates for AMPC and CVA were 40.02% and 13.95%, respectively. The clinical efficacy of BRL 25000 granules was evaluated in 23 patients with upper respiratory tract infections, skin infections, etc. Overall the clinical efficacy was good to excellent in 21/23 (91.3%). The bacteriological and clinical efficacy rates for beta-lactamase producing bacteria and non-producing bacteria were 50% (1/2) and 100% (12/12), respectively. Side effects were observed in 1 patient, who experienced mild diarrhea and abdominal pain but not of a severe nature.

Topics: Administration, Oral; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Kinetics; Male

BRL 25000 granules containing amoxicillin 2 parts and clavulanic acid 1 part, were administered to 14 patients with pediatric infections. The overall efficacy rate was 71.4% (10/14). An adverse reaction was observed in 1 case with diarrhea, but there were no other side effects or abnormal laboratory findings noted.

Topics: Administration, Oral; Adolescent; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Male

BRL 25000 granules containing 2 parts amoxicillin and 1 part potassium clavulanate were administered to children suffering from acute infections at a daily dose of 50 mg/kg in 3 or 4 divided doses for at least 3 days. Infections included acute airway infections (81), scarlet fever and suspected scarlet fever (4), urinary tract infections (4), impetigo contagiosa (1) and acute colitis (1). Bacteria were eradicated in 91.3% (63/69) of cases treated with the BRL 25000 granules, with only 2 strains of Staphylococcus aureus, 2 of Escherichia coli, 1 of Haemophilus influenzae and 1 of Streptococcus pneumoniae remaining. Eight beta-lactamase producing strains were detected amongst the 49 clinical isolates studied and of these, 6 were eradicated after administration of the BRL 25000 granules. Good clinical efficacy was obtained in 97.8% of cases (89/91), with 1 case of acute tonsillitis and 1 of acute colitis showing no improvement. Adverse reactions were limited to 1 case of vomiting and 3 of diarrhea, and no abnormal laboratory findings were detected.

Topics: Administration, Oral; Adolescent; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Male

BRL 25000 granules, a formulation consisting of amoxicillin (AMPC) and clavulanic acid (CVA), was evaluated in the field of pediatrics. In a pharmacokinetic study, serum concentrations were determined in a patient after oral administration of BRL 25000 granules in the non-fasting state at a dose of 11.76 mg/kg. The serum levels of amoxicillin (AMPC) and clavulanic acid (CVA) 1 hour after administration were 7.76 micrograms/ml and 6.64 micrograms/ml, with biological half-lives of 0.86 hour and 0.88 hour respectively. The serum concentration profile at a dose of 31.58 mg/kg showed almost the same tendency as at 11.76 mg/kg, although the peak level and biological half-life of the serum concentrations were not obtained. These serum levels and their peak levels were considered reasonable compared with those obtained in adults at similar dose levels. In clinical studies, 34 patients were evaluated including 8 patients with acute pharyngitis or acute tonsillitis, 1 patient with acute bronchitis, 1 patient with bronchopneumonia, 23 patients with scarlet fever and 1 patient with pertussis. BRL 25000 granules were administered orally 3-4 times per day for 4-8 days to 2 patients at doses of 20 approximately less than 30 mg/kg/day, to 18 patients at doses of 30 approximately less than 40 mg/kg/day, to 11 patients at doses of 40 less than approximately 50 mg/kg/day, and to 3 patients at doses of 50-60 mg/kg/day. The clinical response was assessed excellent in 13 cases and good in 21 cases giving an overall clinical efficacy rate of 100% (34/34). The causative organisms were isolated in 17 cases and included 12 strains of Streptococcus group A, 2 S. pneumoniae, 3 H. influenzae and 1 H. parainfluenzae.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Humans; Infant; Male

Fundamental and clinical studies on BRL 25000 granules, containing 2 parts amoxicillin (AMPC) and 1 part clavulanic acid (CVA) (a beta-lactamase inhibitor) were carried out in the pediatric field. Serum concentrations and urinary excretion rates were determined after oral administration of BRL 25000 granules at a dose of 20 mg/kg to 2 children. The mean peak serum concentrations of AMPC and CVA were 4.89 and 2.85 micrograms/ml at 1 hour after administration, with serum half-lives (T 1/2) of 1.15 and 0.89 hours respectively. Mean cumulative urinary excretion rates of AMPC and CVA in the 6 hours after administration were 24.91% and 10.19%, respectively. BRL 25000 granules were also administered at daily doses of 25.1-60.4 mg/kg in 3 divided doses, to 20 pediatric patients with bacterial infections (4 acute tonsillitis, 2 acute pharyngitis, 3 suspected scarlet fever, 3 acute bronchitis, 8 urinary tract infection). The efficacy rate was 100% clinically and 70% bacteriologically. No adverse reactions were observed, however, abnormal laboratory findings were observed in 4 cases (slight elevation of GOT in 2, GPT in 1, eosinophilia in 1).

Topics: Administration, Oral; Age Factors; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Half-Life; Humans; Infant; Male

The authors have carried out laboratory and clinical studies on the BRL 25000 granule (containing 2 parts amoxicillin and 1 part clavulanic acid). The antibacterial activity of BRL 25000 against 29 clinically isolated strains of S. aureus, 30 E. coli and 30 K. pneumoniae were measured by the agar dilution method using an inoculum size of 10(6) cells/ml. beta-Lactamase production was detected by the Nitrocefin method. The MICs of BRL 25000 against S. aureus ranged from 0.2 approximately 12.5 micrograms/ml, with the majority of strains being inhibited by 1.56 micrograms/ml or less. Seven beta-lactamase producing strains of S. aureus were all inhibited by less than 12.5 micrograms/ml. The range against E. coli was 1.56 approximately 100 micrograms/ml, with the majority inhibited by 6.25 micrograms/ml or less. Fifteen beta-lactamase producing strains of E. coli were inhibited by 6.25 approximately 100 micrograms/ml and the majority by 25 micrograms/ml or less. All strains of K. pneumoniae were beta-lactamase producers and the MIC distribution against K. pneumoniae was 1.56 approximately 50 micrograms/ml, with a majority inhibited by 3.13 micrograms/ml or less, 96% of strains, were inhibited by less than 6.25 micrograms/ml. Against K. pneumoniae, BRL 25000 showed a 8 to 16-fold superiority when compared with AMPC. In a pharmacokinetic study, BRL 25000 granules were orally administered to children in the fasting state at single doses of 7.5 mg/kg and 20 mg/kg. The peak serum levels of AMPC were 6.13 and 6.94 micrograms/ml approximately 1 hour after administration and decreased with half-lives of 1.08 and 0.97 hours, respectively. The corresponding serum levels of CVA were 1.16 and 1.90 micrograms/ml at 1 hour after administration, with half-lives of 0.99 and 0.87 hour, respectively. In clinical studies, the BRL 25000 granule was effective in 39 cases of bacterial infection out of a total of 41 treated. Side effects were limited to 2 cases of diarrhea and minor changes in laboratory findings were elevation of serum GOT (1 case), elevation of serum GPT (1 case), and eosinophilia (2 cases).

Topics: Administration, Oral; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Dosage Forms; Drug Combinations; Drug Evaluation; Female; Half-Life; Humans; Infant; Male

An intravenous formulation of Augmentin was used as sole chemotherapy in the treatment of patients with severe infections. Fourteen of 17 assessable patients (82%) responded satisfactorily including six with bacteraemia. Adverse reactions occurred in 38% of patients but in all but one, withdrawn due to diarrhoea, were trivial. There was no significant intolerance.

Topics: Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Clavulanic Acids; Drug Combinations; Female; Humans; Injections, Intravenous; Male; Microbial Sensitivity Tests; Middle Aged; Sepsis

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Bacterial Infections; Child; Clavulanic Acids; Drug Combinations; Humans; Urinary Tract Infections

The susceptibility to Augmentin of a total of 1,417 bacterial isolates was investigated. Augmentin is a new formulation of the broad-spectrum beta-lactam-antibiotic amoxicillin together with the beta-lactamase-inhibitor clavulanic acid. It was demonstrated that 88% of all isolates tested were sensitive to Augmentin, 9% were resistant. 88% of all Pseudomonas aeruginosa strains fell in the "resistant" category. Only 1/71 anaerobes and 15/286 staphylococci were classified as resistant to Augmentin.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Clavulanic Acids; Drug Combinations; Humans; Microbial Sensitivity Tests; Penicillin Resistance

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Arrhythmia Agents; Anti-Bacterial Agents; Arrhythmias, Cardiac; Bacterial Infections; Belgium; Child; Clavulanic Acids; Drug Combinations; Humans; Lidocaine; Tocainide

We studied BRL 25000, (amoxicillin trihydrate and potassium clavulanate a beta-lactamase inhibitor in ratio of 2: 1), in the otorhinolaryngological field in terms of its basic and clinical utility. Pharmacokinetics The distribution of BRL 25000 in mucous membrane of maxillary sinus and retaining liquid of maxillary sinus after administration of 1 tablet (375 mg) was favorable and the good transitional properties were obtained. It was similar to chephems. Clinical results BRL 25000 was administered to 26 patients (6 cases with otitis media, 9 cases with tonsillitis, 2 cases with sinusitis, 1 case with laryngitis, 5 cases with pharyngitis, 1 case with epipharyngitis and 2 cases with pharyngolaryngitis). The overall clinical effective response was obtained in 88.5% of patients. Bacteriological effects BRL 25000 was effective against amoxicillin-resistant S. aureus and K. rhinoscleromatis. Side effects No adverse reactions were seen.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Clavulanic Acids; Drug Combinations; Drug Evaluation; Female; Humans; Male; Maxillary Sinus; Middle Aged; Otorhinolaryngologic Diseases; Penicillin Resistance

BRL 25000 was administered to 37 cases with infections in the fields of obstetrics and gynecology, and the following results were obtained. The drug was administered to 17 cases with adnexitis, 13 cases with intrauterine infection and 7 cases with parametritis and/or inflammation of pelvic dead space, etc. The percentage of efficacy (excellent and good) was 74.3%. Of 7 cases where no therapeutic effect was obtained with other drugs, the percentage of efficacy was 57.1%. Antibacterial effect of BRL 25000 was studied in terms of percentage of eradication (including replacement) of clinical isolates. A high percentage of eradication (94.4% or 17/18) was obtained. Among all clinical isolates, 37.9% or 11/29 were beta-lactamase producing organisms. Eradication or replacement by BRL 25000 was noted in all these 9 strains, and BRL 25000 was proved to have a high efficacy also against penicillin or cephalosporin resistant organisms. No abnormality was noted in any patient in hematological, hepatic and renal function before and after administration of BRL 25000. As adverse reaction, diarrhea was found in 1 of 37 cases (2.7%), but it reduced after off-dose.

Topics: Adult; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Clavulanic Acids; Drug Combinations; Drug Evaluation; Female; Genital Diseases, Female; Humans; Penicillin Resistance

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Clavulanic Acids; Connective Tissue Diseases; Drug Combinations; Humans; Skin Diseases, Infectious; Urinary Tract Infections

Pharmacokinetics of a parenteral formulation comprised of 5 parts of amoxicillin and 1 part of clavulanic acid were determined in 12 pediatric patients, 2 to 14 years of age. A single dose amounting to 25 mg of amoxicillin and 5 mg of clavulanic acid per kg of body weight was infused intravenously over 2 min. Mean plasma concentrations 5 min after dosing were 89.4 micrograms of amoxicillin per ml and 19.5 micrograms of clavulanic acid per ml. Terminal phase plasma half-lives were 1.2 and 0.8 h, respectively. The data acquired in this study indicate that amoxicillin and clavulanic acid are pharmacokinetically compatible. Moreover, taken with assessment of microbiological activities by others, the present data suggest that intravenous administration of 25 mg of amoxicillin plus 5 mg of clavulanic acid per kg every 6 h is a reasonable starting regimen for assessing the activity of the combined drug formulation in noninvasive childhood diseases caused by Haemophilus influenzae, Staphylococcus aureus, Streptococci spp., Neisseria spp., Branhamella catarrhalis, and other susceptible organisms.

Topics: Adolescent; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acid; Clavulanic Acids; Drug Combinations; Female; Humans; Injections, Intravenous; Kinetics; Male

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Clavulanic Acids; Drug Combinations; Humans; Infant

BRL 25000, consisting of 250 mg amoxicillin (AMPC) and 125 mg clavulanic acid (CVA), was studied in the field of obstetrics and gynecology. Tissue concentrations The concentrations in venous serum and arterial serum of uterus, different sites uterus, oviduct and ovarium were determined. Tissue concentrations of AMPC and CVA corresponded to 45--75% and 20--50%, respectively of serum concentrations. The good responses were obtained in cases with intrapelvic infection and the overall clinical effective responses were obtained in 100% of patients. Effectiveness was found microbiologically and clinically in infections due to AMPC resistant organisms. No side effects were found.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Clavulanic Acids; Drug Combinations; Drug Evaluation; Female; Genital Diseases, Female; Genitalia, Female; Humans; Middle Aged

Twenty-five hospitalised patients were evaluated after treatment with oral augmentin (amoxycillin and clavulanic acid). Ten of 14 with respiratory tract, four of eight with urinary tract and five of five with miscellaneous infections (two with osteomyelitis, two typhoid carriers and one with typhoid fever) were cured. Three of four infections caused by amoxycillin resistant bacteria were cured. The drug was well tolerated even at relatively high clavulanic acid doses up to 1.0 g/day. Augmentin is a potentially useful antibiotic combination.

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; beta-Lactamase Inhibitors; Drug Combinations; Drug Evaluation; Escherichia coli Infections; Female; Humans; Klebsiella Infections; Male; Middle Aged; Penicillin Resistance; Proteus Infections; Respiratory Tract Infections; Urinary Tract Infections

Clavulanic acid is a beta-lactam antibiotic which, although it has little intrinsic activity, is a potent inhibitor of bacterial beta-lactamases. When combined with amoxycillin its range of activity includes penicillinase-producing strains of Staphylococcus aureus and many of the beta-lactamase-producing strains of Gram-negative bacilli. Bacteria sensitive to augmentin include amoxycillin-resistant strains of Haemophilus influenzae and Escherichia coli, in addition strains of Klebsiella aerogenes, Proteus mirabilis, Proteus vulgaris and Bacteroides fragilis are usually sensitive. The beta-lactamases produced by Enterobacter spp, Proteus morgani, Serratia marcescens and Pseudomonas aeruginosa are less susceptible to clavulanic acid and these bacteria are usually resistant to augmentin (1).

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Bacteria; Bacterial Infections; Drug Combinations; Escherichia coli; Humans

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Drug Combinations; Humans; Middle Aged; Penicillin Resistance

Topics: Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacterial Infections; Drug Combinations; Female; Humans; Male; Middle Aged

The therapeutic effects produced by formulations of amoxicillin plus clavulanic acid (BRL 25 000A and BRL 25 000G) were compared with those of amoxicillin and clavulanic acid separately against a variety of infections produced by amoxicillin-susceptible and beta-lactamase-producing (amoxicillin-resistant) bacteria. The infection models studied included intraperitoneal infections, a mouse pneumonia, experimental pyelonephritis, and local lesions caused by Staphylococcus aureus and Bacteroides fragilis. The distribution of amoxicillin and clavulanic acid in infected animals after the administration of amoxicillin-clavulanic acid was evaluated by measurement of the concentrations of the substances present in specimens collected at the sites of infection. The results showed that both amoxicillin and clavulanic acid were well distributed in the animal body after the administration of amoxicillin-clavulanic acid formulations, being present in significant concentrations at various sites of infection, e.g., peritoneal washings, pleural fluid, pus, and infected tissue homogenates. In a number of cases, the amoxicillin concentrations measured after the administration of BRL 25000 were higher than those found after treatment with amoxicillin alone, presumably as a result of inhibition of bacterial beta-lactamases by clavulanic acid at the site of infection. The ability of clavulanic acid to protect amoxicillin in vivo was confirmed by the efficacy of amoxicillin-clavulanic acid formulations in the treatment of the infections studied, most of which were refractory to therapy with amoxicillin.

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Animals; Anti-Bacterial Agents; Bacterial Infections; Bacteroides Infections; Clavulanic Acids; Drug Combinations; Mice; Pneumonia, Staphylococcal; Pyelonephritis

Topics: Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Bacteria; Bacterial Infections; Drug Combinations; Humans; Lactams; Microbial Sensitivity Tests; Penicillin Resistance

Topics: Adolescent; Adult; Aged; Amoxicillin; Amoxicillin-Potassium Clavulanate Combination; Anti-Bacterial Agents; Bacteria; Bacterial Infections; beta-Lactamase Inhibitors; beta-Lactams; Drug Combinations; Female; Humans; Male; Middle Aged; Penicillin Resistance; Urinary Tract Infections