sultamicillin and Bacterial-Infections

Ampicillin-sulbactam has a wide range of antibacterial activity that includes Gram-positive and Gram-negative aerobic and anaerobic bacteria. However, the drug is not active against Pseudomonas aeruginosa and pathogens producing extended-spectrum beta-lactamases. The combination could be considered particularly active against Acinetobacter baumannii infections due to the intrinsic activity of sulbactam. The drug is indicated as empirical therapy for a broad range of community acquired infections supervened in adults or children and is effective in either parenteral (ampicillin-sulbactam) or oral (as a mutual prodrug sultamicillin) form. In clinical trials, sultamicillin has proved clinically and bacteriologically effective in adults and children against a variety of frequently encountered infections, including mild upper and lower respiratory tract infections, urinary tract infections, diabetic foot and skin and soft tissue infections. Furthermore, adverse effects rarely occur with the diarrhoea to represent the most commonly reported. The parenteral ampicillin-sulbactam is indicated for community infections of mild-to-moderate severity acquired infections such as intra-abdominal or gynecological. Moreover, it seems to represent the alternative of choice for the treatment of A. baumannii infections for carbapenem-resistant strains in the nosocomial setting. Thus, ampicillin-sulbactam remains a valuable agent in the physician's armamentarium in the management of adult and pediatric infections.

Topics: Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Clinical Trials as Topic; Drug Resistance, Bacterial; Humans; Sulbactam

In the current context of increasing antimicrobial resistance, it is important to use antibiotics rationally and to re-assess regularly the clinical usefulness of commonly used agents. This review focuses on the efficacy of the beta-lactam ampicillin co-administered with the beta-lactamase inhibitor sulbactam, either parenterally (ampicillin/sulbactam) or orally (sultamicillin), for the treatment of bacterial infections. Clinical findings from the past decade confirm the results of numerous older studies and together provide good evidence to support the continued use of ampicillin/sulbactam and sultamicillin in hospital- and community-acquired infections both in adults and children. This is also recognised in recent published national and international guidelines, many of which recommend ampicillin/sulbactam as first-line therapy for various respiratory and skin infections.

Topics: Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Humans; Sulbactam

Broad-spectrum beta-lactam antibiotics have several advantages in the treatment of intra-abdominal infections. These agents are effective against gram-negative rods and anaerobes, reach therapeutic levels rapidly after parenteral administration, and, in the absence of penicillin allergy, generally exhibit low toxicity. The second-generation cephalosporins (e.g., cefoxitin, cefotetan) are used widely in surgical prophylaxis, trauma, and treatment of mild-to-moderate community-acquired infections, but limitations in their spectra and microbial resistance restrict their utility in more serious infections. Extended-spectrum penicillin/beta-lactamase-inhibitor combinations are effective in the treatment of intra-abdominal infections and include enterococci in their spectrum. Gram-negative aerobe resistance has developed to ampicillin/sulbactam. Piperacillin/tazobactam, a ureidopenicillin with increased gram-negative coverage and enhanced antipseudomonal activity, has proved to be effective in clinical trial therapy for intra-abdominal infections. The very broad spectrum carbapenems--imipenem/cilastatin and meropenem--are effective for serious infections or resistant organisms and are often used in the intensive care unit or for nosocomial intra-abdominal infection. These classes of beta-lactams comprise a range of antimicrobials that can be targeted effectively as single agents to both prevention and treatment of intra-abdominal infection.

Topics: Abdomen; Abdominal Abscess; Ampicillin; Anti-Bacterial Agents; Bacterial Infections; beta-Lactamase Inhibitors; Carbapenems; Cephalosporins; Clavulanic Acids; Drug Resistance, Bacterial; Drug Therapy, Combination; Enzyme Inhibitors; Humans; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Sulbactam; Surgical Wound Infection; Ticarcillin

Topics: Adolescent; Ampicillin; Anti-Bacterial Agents; Bacteremia; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Humans; Infant; Infant, Newborn; Randomized Controlled Trials as Topic; Sulbactam; Treatment Outcome

Topics: Ampicillin; Bacterial Infections; beta-Lactamases; Child; Child, Preschool; Drug Resistance, Microbial; Drug Therapy, Combination; Gram-Negative Bacteria; Gram-Positive Bacteria; Humans; Infant; Microbial Sensitivity Tests; Sulbactam; Treatment Outcome

Sulbactam (SB) and clavulanic acid (CA) are irreversible inhibitors of the beta-lactamases in the Richmond and Sykes classes II-VI. When combined with ampicillin and ticarcillin, SB and CA, respectively, extend the spectrum of activity of these penicillins to include some beta-lactamase-producing aerobes (Enterobacteriaceae, Hemophilus influenzae, staphylococci) and anaerobes (Bacteroides fragilis group) which would otherwise be resistant. Neither effectively inhibits the class I beta-lactamases frequently produced by Pseudomonas aeruginosa, Enterobacter, and Serratia, in part explaining the resistance observed with these organisms. Clinically, both agents were as effective as the comparative therapies in all but two of the trials reviewed. Given the current data, the decision to add these agents to the formulary should be based on hospital resistance patterns and on the cost of these antimicrobials in comparison to conventional therapies.

Topics: Ampicillin; Arthritis, Infectious; Bacterial Infections; Bacteroides fragilis; beta-Lactamase Inhibitors; Clavulanic Acids; Clinical Trials as Topic; Drug Resistance, Microbial; Drug Therapy, Combination; Enterobacteriaceae; Female; Gram-Negative Bacteria; Gram-Positive Bacteria; Humans; Male; Microbial Sensitivity Tests; Osteomyelitis; Pelvic Inflammatory Disease; Respiratory Tract Infections; Sulbactam; Ticarcillin

Topics: Ampicillin; Anti-Infective Agents; Bacterial Infections; Drug Evaluation; Drug Therapy, Combination; Humans; Sulbactam

Sultamicillin at an adult dose of 375-750 mg twice daily or a pediatric dose of 50 mg/kg/d provides effective outpatient/office therapy for community-acquired infections of the upper and lower respiratory tract, urinary tract, and skin/soft tissue structures. Given the incidence of Haemophilus influenzae and Branhamella catarrhalis in otitis media and the frequent occurrence of beta-lactamase-producing strains, it is particularly appropriate for the therapy of otitis media in infants and children. The increasing prevalence of beta-lactamase-producing pathogens in these infections, coupled with the fact that diagnostic bacteriology is often not available or practical in office practice, suggests that the broad use of sultamicillin might be desirable. Several factors support such usage: 1) the superiority of sultamicillin compared with the ampicillin commercial dosage form as a delivery system for ampicillin; 2) the possible occurrence at the infection site of beta-lactamase-producing organisms, not themselves pathogens, which nevertheless impair the activity of the beta-lactam antibiotic against sensitive pathogens; 3) the complementary binding of penicillin-binding proteins by ampicillin and sulbactam in ampicillin-sensitive organisms; 4) the lack of resistance development following repeated exposure of strains sensitive to sulbactam/ampicillin suggested by in vitro studies; and 5) the inability of sulbactam to induce beta-lactamase production. In addition to broad use in community-acquired infections, oral therapy with sultamicillin should also provide convenient outpatient follow-up for initial parenteral sulbactam/ampicillin therapy. Extensive testing of various laboratory parameters has revealed no evidence of systemic toxicity with sultamicillin. The only significant side effect of sultamicillin is diarrhea/loose stools, which, although a frequent complaint in some studies, is of mild to moderate severity and results in a low discontinuation rate.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ampicillin; Bacteria; Bacterial Infections; beta-Lactamases; Child; Child, Preschool; Clinical Trials as Topic; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Humans; Infant; Male; Middle Aged; Sulbactam

The combination of sulbactam and ampicillin is a safe and effective therapy for acute otitis media and acute epiglottitis in infants and children. Despite the lack of similar studies proving efficacy for other infections of the upper airway and certain adjacent structures, such as sinusitis, tonsillitis and cellulitis/abscess of the head and neck, this drug combination should also have a therapeutic role in the future for these conditions.

Topics: Ampicillin; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Epiglottitis; Female; Humans; Infant; Male; Otitis Media; Respiratory Tract Infections; Sinusitis; Sulbactam

Sultamicillin is the tosylate salt of the double ester of sulbactam plus ampicillin. Sulbactam is a semisynthetic beta-lactamase inhibitor which, in combination with ampicillin, extends the antibacterial activity of the latter to include some beta-lactamase-producing strains of bacteria that would otherwise be resistant. The combination of sulbactam plus ampicillin for parenteral use has previously been shown to be clinically and bacteriologically effective in a variety of infections. The chemical linkage of sulbactam and ampicillin has now produced an orally effective compound, sultamicillin, with antibacterial activity and clinical efficacy which are similar to those of the parenteral formulation. Sultamicillin has been shown to be clinically effective in non-comparative trials in patients with infections of the respiratory tract, ears, nose and throat, urinary tract, skin and soft tissues, as well as in obstetric and gynaecological infections, and in the treatment of gonorrhoea. In a small number of controlled trials, sultamicillin has shown comparable clinical efficacy to phenoxymethyl penicillin (penicillin V) and to amoxycillin (alone and in combination with clavulanic acid) in the treatment of paediatric streptococcal pharyngitis and acute otitis media, respectively; to cefaclor in the treatment of acute otitis media in adults; and to bacampicillin, cloxacillin and flucloxacillin plus ampicillin in skin and soft tissue infections in adults, children and adult diabetic patients, respectively. Sultamicillin was superior in efficacy to bacampicillin in the treatment of chronic respiratory infections, to cefaclor in the treatment of acute otitis media in adults, and to cefadroxil in the treatment of patients with complicated urinary tract infections. However, in single-dose treatment of uncomplicated gonorrhoea, sultamicillin (1500mg plus probenecid 1g) was inferior to a 2g intramuscular dose of spectinomycin. While in several studies the incidence of diarrhoea associated with sultamicillin was greater than that with comparative antibacterials, sultamicillin-associated diarrhoea was generally mild and transitory, although occasionally severe enough to necessitate discontinuation of treatment. Further studies in larger groups of patients are needed to clarify the therapeutic efficacy and safety of sultamicillin in comparison with other antibacterial regimens, and to determine the optimum single dosage for the treatment of gonorrhoea. Nonetheless, sultam

Topics: Ampicillin; Animals; Bacteria; Bacterial Infections; Drug Therapy, Combination; Humans; Sulbactam

Topics: Ampicillin; Ampicillin Resistance; Bacterial Infections; Drug Therapy, Combination; Humans; Sulbactam; Surgical Wound Infection

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

Soft tissue and bone infections of the lower limb continue to be a frequent and serious complication in patients with diabetes mellitus. The best choice of antimicrobial for the empiric treatment of moderate to severe diabetic foot infections has not been established clearly.. We conducted a prospective, randomized, open-label, multicenter trial comparing piperacillin/tazobactam (P/T) (4 g/0.5 g q8h) and ampicillin/sulbactam (A/S) (2 g/1 g q6h) as a parenteral treatment for 314 adult patients with moderate-to-severe infected diabetic foot ulcers. Patients with polymicrobial infections involving methicillin-resistant Staphylococcus aureus also received vancomycin 1 g q12h.. Clinical efficacy rates (cure or improvement) were statistically equivalent overall (81% for P/T vs. 83.1% for A/S), and median duration of treatment was similar in the clinically evaluable populations (nine days for P/T, 10 days for A/S). Drug-related adverse events for both study drugs were comparable in frequency and type.. Although both study drugs provide safe and effective empiric treatment for moderate-to-severe infected diabetic foot ulcers, piperacillin/tazobactam has the advantage of covering Pseudomonas aeruginosa (bacteriologic success rate of 85.7%), the most commonly isolated gram-negative pathogen in this study.

Topics: Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Diabetic Foot; Female; Humans; Male; Middle Aged; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Prospective Studies; Sulbactam; Time Factors; Vancomycin; Wound Infection

An acute bleeding from oesophageal varices as a result of portal hypertension is a frequent and at the same time serious complication of cirrhosis of the liver. One of factors influencing this bleeding can be a bacterial infection. Endotoxines can increase portal pressure and so participate in development of bleeding and simultaneously deteriorate a patient's prognosis. An antibiotic treatment is a part of a treatment algorithm, however what antibiotics to administer and in what manner is unclear. A group of 46 patients who were admitted to a hospital for an acute bleeding from varices has been compared in the study to 48 cirrhosis patients hospitalised for other reasons. An infection incidence was high in both groups (63.0 % vs. 54.2 %), bleeding patients had more often positive hemoculture (17.3 % vs. 8.6 %), and statistically significantly more often positive findings in throat swab culture (36.9 % vs. 17.3 %, p = 0.04) which is an evidence of an increased pathology colonisation of these patients. Bleeding patients were randomised for peroral norfloxacin administration (n = 25) or an intravenous administration of a combination of ampicilin and sulbactam (n = 21). There was no difference in survival of both groups. Due to a high number of bacterial infections antibiotics administration has been indicated in these patients. Intravenous administration is probably of the same effect as peroral administration.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Esophageal and Gastric Varices; Female; Gastrointestinal Hemorrhage; Humans; Hypertension, Portal; Infusions, Intravenous; Liver Cirrhosis; Male; Middle Aged; Norfloxacin; Sulbactam

A randomized, double-blind trial compared the clinical and bacteriologic efficacy of ampicillin/sulbactam (2 g/1 g) and cefoxitin (2 g) administered intravenously every 6 h to patients with (n=49) or without (n=47) histories of injection drug abuse who presented with cutaneous or other soft-tissue infections. Cure or improvement occurred in 89.8% of ampicillin/sulbactam-treated patients, compared with 93.6% of cefoxitin-treated patients. The median time to resolution of all symptoms was 10.5 days with ampicillin/sulbactam treatment and 15.5 days with cefoxitin treatment. Mixed aerobic-anaerobic infection was encountered frequently in both treatment groups. A significantly higher percentage of Streptococcus species was found in the major abscesses of the patients with histories of injection drug abuse, compared with those without such histories (37% vs. 19%, respectively; P=.0009). Overall, ampicillin/sulbactam eradicated pathogens from the major abscesses in 100% of patients, whereas the eradication rate with cefoxitin was 97.9%. The 2 drugs were well tolerated. Ampicillin/sulbactam and cefoxitin were equally effective for the empirical treatment of cutaneous or other soft-tissue infections in injection drug abusers and patients who did not inject drugs.

Topics: Abscess; Adult; Ampicillin; Bacteria; Bacterial Infections; Cefoxitin; Cephamycins; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Skin Diseases, Bacterial; Soft Tissue Infections; Substance Abuse, Intravenous; Sulbactam

To determine if an antibiotic reduces the incidence of complications associated with influenza-like illness during an influenza epidemic.. During the outbreak of influenza in Kobe in 1998, 85 patients suffering from an influenza-like illness were randomly assigned to two groups. Patients received placebo or sultamicillin orally for 4 days. The incidence of complications of influenza-like illness were compared and statistically assessed.. There was no difference in the duration of fever or the incidence of acute otitis media. However, the incidence of pneumonia was significantly lower in the sultamicillin group than the placebo group (2.4 vs 16.3%, P < 0.05).. Sultamicillin reduced the incidence of pneumonia associated with influenza-like illness during the influenza epidemic. This result suggests that antibiotics can reduce the rate of pneumonia associated with influenza.

Topics: Acute Disease; Ampicillin; Bacterial Infections; Child, Preschool; Diarrhea; Disease Outbreaks; Drug Therapy, Combination; Female; Fever; Humans; Incidence; Influenza A virus; Influenza, Human; Japan; Male; Otitis Media; Pneumonia, Bacterial; Population Surveillance; Sulbactam; Urban Health

Topics: Administration, Oral; Adolescent; Ampicillin; Anti-Bacterial Agents; Argentina; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Female; Gram-Positive Bacteria; Humans; Infant; Male; Penicillins; Prospective Studies; Sulbactam; Treatment Outcome

Topics: Abdominal Abscess; Aminoglycosides; Ampicillin; Bacterial Infections; Child; Child, Preschool; Clindamycin; Drug Therapy, Combination; Female; Gentamicins; Gram-Negative Bacteria; Gram-Positive Bacteria; Humans; Infant; Male; Prospective Studies; Species Specificity; Sulbactam; Tobramycin; Treatment Outcome

Fifty-three hospitalized patients suffering from lower respiratory tract infections were evaluated in a randomized, comparative trial studying the safety and efficacy of ampicillin/sulbactam (2 g ampicillin plus 1 g sulbactam intravenously every 6 h) versus cefotaxime (2 g intravenously every 6 h). Thirty-four of the 36 and 16 of the 17 patients treated with ampicillin/sulbactam and cefotaxime, respectively, were evaluable. Clinical and bacteriologic efficacy did not differ significantly between the two treatment groups (p = 0.828 and p = 0.648, respectively). Twenty-one (61.8%) of the ampicillin/sulbactam-treated patients were cured, eight (23.5%) improved and four (11.8%) were treatment failures. Nine (56.3%) of the cefotaxime treated patients were cured, four (25.0%) improved and two (12.5%) failed therapy. All primary pathogens were eradicated in 19 (55.9%) of the ampicillin/sulbactam group and were partially eradicated in seven (20.6%) patients. In the cefotaxime treatment group bacteriologic eradication occurred in 10 (62.5%) and partial eradication in two (12.5%) patients. Both study drugs were well tolerated, as the number of adverse reactions in each treatment group was small and similar between the two groups. Ampicillin/sulbactam appears to be as safe and effective as cefotaxime in the therapy of hospitalized patients with lower respiratory tract infections caused by beta-lactamase positive and beta-lactamase negative pathogens.

Topics: Adult; Aged; Ampicillin; Bacterial Infections; Cefotaxime; Drug Therapy, Combination; Female; Hospitalization; Humans; Male; Middle Aged; Respiratory Tract Infections; Sulbactam

In a randomized prospective study ampicillin/sulbactam and cefamandole were compared in the therapy of patients hospitalized with community acquired pneumonia. Patients receiving ampicillin/sulbactam (n = 37) and cefamandole (n = 38) were similar with respect to age (mean age 70 vs. 76 years respectively), clinical characteristics, severity of illness and underlying disease. Pathogens isolated from patients in the cefamandole and ampicillin/sulbactam group, respectively, were Streptococcus pneumoniae (7 vs. 7 patients), Haemophilus parainfluenzae (7 vs. 6 patients), Haemophilus influenzae (5 vs. 5 patients), Staphylococcus aureus (5 vs. 4 patients), Escherichia coli (4 vs. 4 patients), Klebsiella pneumoniae (3 vs. 3 patients), Enterobacter spp. (2 vs. 3 patients), Moraxella catarrhalis (1 vs. 2 patients), and organisms of the oral flora (4 vs. 3 patients). The rate of resistance to penicillin was 80%, to clindamycin 76%, to erythromycin 45%, to ampicillin 43%, and to cefazolin 18%. Overall successful treatment rates of 81% for cefamandole and 97% for ampicillin/sulbactam (p = 0.05) were observed. Both cefamandole and ampicillin/sulbactam were shown to be effective agents for therapy of community acquired pneumonia; however ampicillin/sulbactam demonstrated superior overall clinical efficacy.

Topics: Adult; Aged; Aged, 80 and over; Ampicillin; Bacteria; Bacterial Infections; Cefamandole; Community-Acquired Infections; Female; Humans; Male; Middle Aged; Pneumonia; Prospective Studies; Sputum; Sulbactam

A double-blind trial was conducted in 385 patients with suspected bacterial intra-abdominal infections to compare the efficacy and safety of ampicillin-sulbactam with cefoxitin. Patients were randomized to receive either 3 g ampicillin-sulbactam (2 g ampicillin-1 g sulbactam), or 2 g cefoxitin, every 6 hours. To be evaluable, patients had to demonstrate positive culture evidence of peritoneal infection at the time of operation. A total of 197 patients were evaluable for clinical efficacy. The two treatment groups were comparable in demographic features and in the presence of risk factors for infection. Clinical success (absence of infection and of adverse drug reaction) was observed in 86% of patients in the ampicillin-sulbactam group and 78% in the cefoxitin group. Eradication of infection occurred in 88% of the ampicillin-sulbactam group and 79% of the cefoxitin group. There were no differences in the nature or frequency of side effects observed in the two groups. Ampicillin-sulbactam demonstrated no difference in safety or efficacy when compared with cefoxitin in the treatment of serious intra-abdominal infections of bacterial origin.

Topics: Abdomen, Acute; Adult; Ampicillin; Bacterial Infections; Cefoxitin; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Peritonitis; Prospective Studies; Sulbactam

In an open study, children (age range 6 months-12 years) with otitis media due to a bacterial infection were treated orally with 50 mg/kg sultamicillin (n = 30) in two equal doses each day for a mean of 10 days, or 40 mg/kg cefaclor (n = 30) in three equal doses each day for a mean of 11 days. Earache was rapidly improved by either treatment; none of the 27 evaluable sultamicillin-treated or the 29 evaluable cefaclor-treated patients had earache after 8-10 days. Other signs and symptoms (reddened eardrums, perforated eardrums, middle ear fluid, hearing loss) gradually improved during treatment. All the pathogens isolated from patients in the sultamicillin treatment group were eradicated, as were all but one of the pathogens isolated from patients in the cefaclor treatment group. In the sultamicillin treatment group 65.4% of patients were cured and 34.6% were improved, and in the cefaclor group 65.5% were cured and 31.0% improved, but there was one treatment failure. Study drug-related adverse events were experienced by 33.3% of sultamicillin- and 40.0% of cefaclor-treated patients, all but one (urticaria in a cefaclor-treated patient) were gastro-intestinal. The dose administered was reduced by approximately 50% in patients experiencing adverse effects. This did not lead to any reduction in efficacy and no patient was withdrawn due to adverse events.

Topics: Acute Disease; Administration, Oral; Ampicillin; Bacterial Infections; Cefaclor; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Otitis Media; Sulbactam

A total of 110 adults with acute ear, nose and throat infections were treated orally with 750 mg/day (n = 9) or 1500 mg/day (n = 46) sultamicillin, or 500 mg/day (n = 51) or 1000 mg/day (n = 4) cefuroxime axetil for a minimum of 5 days. Variations in dose and duration of treatment were due to severity of symptoms. After treatment with sultamicillin for 8.1 +/- 1.5 days or with cefuroxime axetil for 7.9 +/- 1.6 days, local pain, erythema, exudate, oedema and adenopathies were improved in both treatment groups and all sultamicillin-treated patients were apyretic. All sultamicillin-treated and all but three cefuroxime axetil-treated patients experienced cure or improvement; only one cefuroxime axetil-treated patient discontinued treatment due to treatment failure. Gastrointestinal adverse events occurred in both treatment groups (eight sultamicillin-treated patients and three cefuroxime axetil-treated patients); one patient receiving cefuroxime axetil discontinued treatment due to nausea. Pruritus was reported by one sultamicillin-treated patient.

Topics: Adult; Ampicillin; Bacterial Infections; Cefuroxime; Drug Therapy, Combination; Humans; Otitis Media; Pharyngitis; Respiratory Tract Diseases; Rhinitis; Sinusitis; Sulbactam; Tonsillitis

Subclinical infection may play a role in the failure of magnesium sulfate tocolysis. Using a double-blind randomized study design, we administered a combination of ampicillin-sulbactam and indomethacin or corresponding placebos to patients in preterm labor who were receiving intravenous magnesium sulfate tocolysis. The mean gestational age at enrollment was 30.1 weeks, and mean cervical dilatation was 2.15 cm. No differences were noted between placebo (n = 43) and study patients (n = 43) in gestational age at delivery, term deliveries, days gained, or neonatal outcome. Preterm delivery (less than 36 weeks) occurred in 61% of the total population. The likelihood of a beta error was 0.07 to 0.23 on the basis of outcome analysis. In our population adjunctive ampicillin-sulbactam with indomethacin did not improve the success of magnesium sulfate tocolysis.

Topics: Ampicillin; Bacterial Infections; Double-Blind Method; Drug Therapy, Combination; Female; Humans; Indomethacin; Magnesium Sulfate; Obstetric Labor, Premature; Pregnancy; Pregnancy Outcome; Sulbactam

Topics: Ampicillin; Bacterial Infections; Clindamycin; Double-Blind Method; Drug Synergism; Drug Therapy, Combination; Gentamicins; Humans; Microbial Sensitivity Tests; Sulbactam; Time Factors

Clinical efficacy and safety of sultamicillin (SBTPC) in patients with lower respiratory tract infections, mainly pneumonia and bronchitis, have been evaluated in a multicenter trial by 19 institutions in the Kyushu area during a period of 12 months from December 1988 to November 1989. 1. Clinical evaluation was made in 132 patients and efficacy rates of SBTPC were 80.0% (28/35) for pneumonia, 78.5% (73/93) for bronchitis and 100% for the remaining 1 patient with other respiratory tract infections. The overall efficacy rate was 79.1% (102/129). 2. Clinical efficacy rate of SBTPC for respiratory tract infections in patients with underlying diseases such as chronic bronchitis, old pulmonary tuberculosis etc., was 75.0% (60/80) which was not significantly different from the efficacy rate of 85.7% (42/49) in patients without underlying diseases. 3. Of 13 patients who failed to respond to previous antibiotic treatments, 8 (61.5%) were effectively treated with SBTPC. 4. Clinical efficacy rates against infections caused by single species of organisms were 90.9% (10/11) for Haemophilus influenzae, 100% (8/8) for Streptococcus viridans and 100% (3/3) for Staphylococcus aureus. The overall clinical efficacy rate in all cases of monomicrobial infections was 88.6% (31/35), in polymicrobial infection 45.5% (5/11) and the overall efficacy rate in cases in which causative bacteria were identified was 78.3% (35/46). 5. Adverse reactions occurred in 6.8% (9/132) of the patients. The symptoms included allergic reaction in 1 patient, gastrointestinal system disorders in 7 patients and general fatigability in 1 patient. As abnormalities in laboratory test values, elevations of A1-P, GOT, and GPT were observed in 3 patients during the study, but returned to normal after discontinuation of SBTPC administration. 6. SBTPC is a useful antibiotic in the treatment of lower respiratory tract infections under the current medical environment where resistant organisms which produce beta-lactamases have been increasing.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ampicillin; Bacterial Infections; Bronchitis; Drug Therapy, Combination; Female; Humans; Japan; Male; Middle Aged; Pneumonia; Respiratory Tract Infections; Sulbactam

Sultamicillin at an adult dose of 375-750 mg twice daily or a pediatric dose of 50 mg/kg/d provides effective outpatient/office therapy for community-acquired infections of the upper and lower respiratory tract, urinary tract, and skin/soft tissue structures. Given the incidence of Haemophilus influenzae and Branhamella catarrhalis in otitis media and the frequent occurrence of beta-lactamase-producing strains, it is particularly appropriate for the therapy of otitis media in infants and children. The increasing prevalence of beta-lactamase-producing pathogens in these infections, coupled with the fact that diagnostic bacteriology is often not available or practical in office practice, suggests that the broad use of sultamicillin might be desirable. Several factors support such usage: 1) the superiority of sultamicillin compared with the ampicillin commercial dosage form as a delivery system for ampicillin; 2) the possible occurrence at the infection site of beta-lactamase-producing organisms, not themselves pathogens, which nevertheless impair the activity of the beta-lactam antibiotic against sensitive pathogens; 3) the complementary binding of penicillin-binding proteins by ampicillin and sulbactam in ampicillin-sensitive organisms; 4) the lack of resistance development following repeated exposure of strains sensitive to sulbactam/ampicillin suggested by in vitro studies; and 5) the inability of sulbactam to induce beta-lactamase production. In addition to broad use in community-acquired infections, oral therapy with sultamicillin should also provide convenient outpatient follow-up for initial parenteral sulbactam/ampicillin therapy. Extensive testing of various laboratory parameters has revealed no evidence of systemic toxicity with sultamicillin. The only significant side effect of sultamicillin is diarrhea/loose stools, which, although a frequent complaint in some studies, is of mild to moderate severity and results in a low discontinuation rate.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ampicillin; Bacteria; Bacterial Infections; beta-Lactamases; Child; Child, Preschool; Clinical Trials as Topic; Drug Resistance, Microbial; Drug Therapy, Combination; Female; Humans; Infant; Male; Middle Aged; Sulbactam

Sultamicillin is a substance in which sulbactam, a beta-lactamase inhibitor, is covalently linked through an ester group to ampicillin. This paper describes the results of a clinical trial with sultamicillin in the infectious diseases encountered in internal medicine. In an open segment of the trial, 426 adult patients were treated orally with sultamicillin. The efficacy rates achieved were 86.1% (136/158) in acute respiratory infections, 67.5% (137/203) in chronic respiratory infections, 92.9% (39/42) in acute urinary tract infections, 76.9% (10/13) in chronic urinary tract infections, and 70.0% (7/10) in other types of infections. The bacteriological efficacy of sultamicillin was 83.8% (62/74) for Gram-positive and 74.0% (159/215) for Gram-negative bacteria. Efficacy was similar, 81% (17/21), for those strains that were high producers of beta-lactamase. Adverse reactions were observed in 10.1% of the patients in the open phase of the trial. In the double-blind segment, sultamicillin was compared with bacampicillin in respiratory infections, including pneumonia, lung abscesses, and chronic respiratory tract infections. One tablet of either drug was given orally three times a day for 14 d. Evaluation of clinical effectiveness by the trial committee revealed efficacy rates of 82.8% (96/116) for sultamicillin and 69.8% (81/116) for bacampicillin, indicating a significant superiority for sultamicillin. All of this difference resulted from the superior efficacy of sultamicillin (89.2%) over that of bacampicillin (63.2%) in patients with chronic respiratory infections. Efficacy in pneumonia was the same for both agents. Adverse reactions to sultamicillin and bacampicillin were observed in 16.3% (21/129) and 6.3% (8/127) of the cases, respectively.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Aged; Ampicillin; Bacterial Infections; Clinical Trials as Topic; Double-Blind Method; Drug Therapy, Combination; Humans; Middle Aged; Respiratory Tract Infections; Safety; Sulbactam; Urinary Tract Infections

Sultamicillin, a novel compound in which ampicillin and the beta-lactamase inhibitor sulbactam are linked as a double ester, was compared with trimethoprim/sulfamethoxazole with regard to in vitro activity, therapeutic efficacy and safety in the treatment of UTIs. The MICs of ampicillin and ampicillin in combination with sulbactam (10 micrograms), trimethoprim and trimethoprim in combination with sulfamethoxazole (1:19) were determined for 400 isolates causing UTI using an agar dilution technique (multipointer, cfu = 10(4]. The organisms isolated consisted of about one-third E. coli, one-third other Gram-negative strains and one-third Gram-positive strains. About half of the Gram-positive strains were enterococci and the other half staphylococci. A concentration of 8 micrograms/ml ampicillin inhibited 76% of the isolates while ampicillin in combination with sulbactam inhibited 86%. A concentration of 4 micrograms/ml trimethoprim inhibited 77% of the isolates, while trimethoprim in combination with sulfamethoxazole inhibited 83%. In a prospectively randomized clinical trial, 38 patients with UTI were treated orally with either sultamicillin (375 mg) or trimethoprim/sulfamethoxazole (160 mg/800 mg) twice daily for 7 d. Sultamicillin eradicated bacteriuria during therapy and up to 1 to 2 weeks after therapy in 63% and trimethoprim/sulfamethoxazole in 50% of evaluable patients. Side effects were reported for 2 sultamicillin (gastric pain, diarrhea) and 2 trimethoprim/sulfamethoxazole patients (gastric pain, exanthema), with the latter 2 being withdrawn after 6 days of therapy. Sultamicillin appeared as effective and safe as trimethoprim/sulfamethoxazole in the treatment of UTI.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ampicillin; Bacterial Infections; Clinical Trials as Topic; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Random Allocation; Sulbactam; Sulfamethoxazole; Trimethoprim; Urinary Tract Infections

An open multicenter study was carried out to evaluate the efficacy and safety of sultamicillin in patients with urinary tract infections or gonococcal urethritis. 1) Sultamicillin (750-2250 mg/day) was administered for 3 d to 196 patients with acute uncomplicated cystitis. The most common dosage regimen was 375 mg three times daily. The results of treatment based on the combination of changes in symptoms, pyuria and bacteriuria were excellent in 66.8%, moderate in 30.6% and poor in 2.6% of cases. Of 203 strains isolated before treatment, 185 (91.1%) were eradicated. The eradication rate for E. coli, the most common pathogen (167 strains), was 92.2%. 2) In total, 368 patients with complicated urinary tract infections were treated with 750-2250 mg/d of sultamicillin for 5 d. The most common dosage regimens were 375 mg three times daily and 750 mg twice daily. The clinical results based on the combination of changes in pyuria and bacteriuria were excellent in 30.4%, moderate in 35.6% and poor in 34.0% of cases. Of 470 strains isolated before treatment, 352 (74.9%) were eradicated. The eradication rate achieved with high beta-lactamase-producing organisms (64.1%) was not significantly different from that achieved with low or non-producers (75.6%). 3) Sultamicillin (750-3000 mg/d) was administered to 367 male patients with gonococcal urethritis for 3 to 7 d. The eradication rate ranged from 92.3% with 750 mg/d to 100% with greater than or equal to 1500 mg/d. The effect of dose was particularly evident with the 27 strains of gonococci that had penicillinase activity.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Aged; Ampicillin; Bacterial Infections; Cystitis; Drug Therapy, Combination; Female; Gonorrhea; Humans; Male; Middle Aged; Multicenter Studies as Topic; Sulbactam; Urethritis; Urinary Tract Infections

Thirty hospitalised patients with acute purulent exacerbations of chronic bronchitis were treated orally with either 750 or 1000 mg of sultamicillin (a mutual prodrug of ampicillin and sulbactam) twice daily for ten days. Twenty-eight of these patients were evaluated for clinical response at end-of-treatment (day 11) and at one week post-treatment (day 17). The overall clinical cure rates at these times were 73% (22/30) and 60% (18/30) respectively. Five beta-lactamase-producing organisms were identified in the pre-treatment sputum specimens, but all were eliminated by day 17. The means of the peak serum concentrations of ampicillin achieved after the first 750 and 1000 mg doses were 9.1 and 14.4 mg/l respectively, the corresponding values for sulbactam being 6.4 and 7.9 mg/l. Both the ampicillin and the sulbactam peaks occurred approximately one hour after dosage. Mean peak sputum concentrations of ampicillin of 0.7 and 1.2 mg/l were achieved following the 750 and 1000 mg doses. Concentrations of sulbactam in sputum were above the limit of detection (0.5 mg/l) in only four patients. Although both clinical and bacteriological responses at follow-up (day 17) appeared to be somewhat more favourable at the higher dose, the small number of patients in each group did not permit a statistically valid comparison to be made. One patient in each dosage group discontinued the medication because of severe diarrhoea.

Topics: Adult; Aged; Ampicillin; Bacterial Infections; Bronchitis; Clinical Trials as Topic; Diarrhea; Drug Combinations; Female; Humans; Kinetics; Male; Middle Aged; Penicillanic Acid; Sputum; Sulbactam; Time Factors

Drug-induced liver injury (DILI) is an adverse reaction caused by ampicillin/sulbactam (ABPC/SBT). The albumin-bilirubin (ALBI) score is an index of hepatic functional reserve. However, the relationship between ABPC/SBT-induced DILI and ALBI score remains unknown; therefore, we aimed to elucidate the risk of ABPC/SBT-induced DILI based on the ALBI score.. This was a single-center, retrospective, case-control study using electronic medical records. A total of 380 patients were enrolled in the present study, and the primary outcome was ABPC/SBT-induced DILI. The ALBI score was calculated using serum albumin and total bilirubin levels. In addition, we performed COX regression analysis using age ≥75 years, dose ≥9 g/day, alanine aminotransferase (ALT) ≥21 IU/L, and ALBI score ≥-2.00 as covariates. We also performed 1:1 propensity score matching between non-DILI and DILI groups.. The incidence of DILI was 9.5% (36/380). According to COX regression analysis, the adjusted hazard ratio for ABPC/SBT-induced DILI with an ALBI score ≥-2.00 was 2.55 (95% confidence interval: 1.256-5.191, P = 0.010), suggesting that patients with baseline ALBI score ≥-2.00 may be at high risk for ABPC/SBT-induced DILI. However, significant differences were not observed in cumulative risk for DILI between non-DILI and DILI patients regarding an ALBI score ≥-2.00 after propensity score matching (P = 0.146).. These findings suggest that ALBI score may be a simple and potentially useful index for predicting ABPC/SBT-induced DILI. In patients with an ALBI score ≥-2.00, frequent liver function monitoring should be considered to prevent ABPC/SBT-induced DILI.

Topics: Age Factors; Aged; Ampicillin; Bacterial Infections; Bilirubin; Case-Control Studies; Chemical and Drug Induced Liver Injury, Chronic; Drug Therapy, Combination; Humans; Retrospective Studies; Serum Albumin; Sulbactam

Cephalosporin is the most commonly used empirical agent for urinary tract infections (UTIs) in children. However, increasing use of cephalosporins can lead to an increase in resistant pathogens. This study therefore aims to investigate the effects of monotherapy with ampicillin-sulbactam as an alternative to cephalosporins.. All 2- to 24-month-old patients who were hospitalized at Pusan National University Children's Hospital due to a first episode of a febrile UTI during the 2-year period from 2012 to 2014 were included in the study. The subjects were divided into two groups according to their empirical therapy (cefotaxime or ampicillin-sulbactam). We determined the patients' UTI pathogens and their antibiotic susceptibilities and compared the effectiveness and the occurrence of adverse effects of ampicillin-sulbactam and cephalosporin therapy.. Forty-six patients were treated with cefotaxime (group A) and 41 patients with ampicillin-sulbactam as the empirical antibiotic (group B). The most common pathogen in both groups was Escherichia coli, and antibiotic susceptibilities of the bacterial strains isolated from both groups were similar in ampicillin-sulbactam and cefotaxime. In addition, there was no significant difference in the duration of fever after treatment between the two groups (group A: 2.0 versus group B: 3.0, P = 0.331). There were no treatment failures and no recurrence in either group, even in patients with resistant pathogens. The most common side effect of the antibiotic agents was diarrhea.. Ampicillin-sulbactam could be an effective alternative to cephalosporin as empiric antibiotic for the treatment of first-episode UTI in patients under 24 months of age.

Topics: Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Humans; Infant; Sulbactam; Urinary Tract Infections

The coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has spread worldwide. Bacterial co-infections are associated with unfavourable outcomes in respiratory viral infections; however, microbiological and antibiotic data related to COVID-19 are sparse. Adequate use of antibiotics in line with antibiotic stewardship (ABS) principles is warranted during the pandemic. We performed a retrospective study of clinical and microbiological characteristics of 140 COVID-19 patients admitted between February and April 2020 to a German University hospital, with a focus on bacterial co-infections and antimicrobial therapy. The final date of follow-up was 6 May 2020. Clinical data of 140 COVID-19 patients were recorded: The median age was 63.5 (range 17-99) years; 64% were males. According to the implemented local ABS guidelines, the most commonly used antibiotic regimen was ampicillin/sulbactam (41.5%) with a median duration of 6 (range 1-13) days. Urinary antigen tests for Legionella pneumophila and Streptococcus peumoniae were negative in all cases. In critically ill patients admitted to intensive care units (n = 50), co-infections with Enterobacterales (34.0%) and Aspergillus fumigatus (18.0%) were detected. Blood cultures collected at admission showed a diagnostic yield of 4.2%. Bacterial and fungal co-infections are rare in COVID-19 patients and are mainly prevalent in critically ill patients. Further studies are needed to assess the impact of antimicrobial therapy on therapeutic outcome in COVID-19 patients to prevent antimicrobial overuse. ABS guidelines could help in optimising the management of COVID-19. Investigation of microbial patterns of infectious complications in critically ill COVID-19 patients is also required.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ampicillin; Anti-Bacterial Agents; Antifungal Agents; Antimicrobial Stewardship; Aspergillosis; Azithromycin; Bacterial Infections; Cohort Studies; Coinfection; COVID-19; Enterobacteriaceae Infections; Escherichia coli Infections; Female; Germany; Humans; Klebsiella Infections; Linezolid; Male; Meropenem; Middle Aged; Piperacillin, Tazobactam Drug Combination; Practice Patterns, Physicians'; Retrospective Studies; SARS-CoV-2; Staphylococcal Infections; Streptococcal Infections; Sulbactam; Vancomycin; Young Adult

The impact of bacterobilia on postoperative surgical and infectious complications after partial pancreaticoduodenectomy (PD) is still a matter of debate.. All patients undergoing PD with and without a preoperative biliary drainage (PBD) with complete information regarding microbial bile colonization were included. Logistic regression was applied to assess the influence of bacterobilia on postoperative outcome.. One hundred seventy patients were retrospectively analysed. Clinically relevant postoperative complications (Clavien-Dindo ≥ III) occurred in 40 (23.5%) patients, clinically relevant postoperative pancreatic fistulas in 29 (17.1%) patients, and surgical site infections (SSIs) in 16 (9.4%) patients. Thirty-seven of 39 (94.9%) patients with PBD and 33 of 131 (25.2%) patients without PBD had positive bile cultures (p < 0.001). A polymicrobial bile colonization was reported in 9 of 33 (27.3%) patients without PBD and 27 of 37 (73%) patients with PBD (p < 0.001). Resistance to ampicillin-sulbactam was shown in 26 of 37 (70.3%) patients with PBD and 12 of 33 (36.4%) patients without PBD (p = 0.001). PBD (OR 0.015, 95% CI 0.003-0.07, p < 0.001) and male sex (OR 3.286, 95% CI 1.441-7.492, p = 0.005) were independent predictors of bacterobilia in the multivariable analysis. Bacterobilia was the only independent predictor of SSIs in the multivariable analysis (OR 0.143, 95% CI 0.038-0.535, p = 0.004).. Patients with a PBD show significantly higher rates of bacterobilia, polymicrobial bile colonization, and resistance to ampicillin-sulbactam. Bacterobilia is an independent predictor of SSI after PD.

Topics: Aged; Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Bile; Drainage; Drug Resistance, Bacterial; Female; Humans; Jaundice, Obstructive; Male; Middle Aged; Pancreatic Fistula; Pancreatic Neoplasms; Pancreaticoduodenectomy; Preoperative Care; Preoperative Period; Retrospective Studies; Risk Factors; Sex Factors; Sulbactam; Surgical Wound Infection

Topics: Age Factors; Ampicillin; Anti-Bacterial Agents; Bacterial Infections; C-Reactive Protein; Cefotaxime; Child, Preschool; Diagnosis, Differential; Diagnostic Errors; Female; Humans; Immunoglobulins, Intravenous; Immunologic Factors; Infant; Leukocytosis; Male; Mucocutaneous Lymph Node Syndrome; Pyuria; Republic of Korea; Retrospective Studies; Sulbactam

Appendicitis is a frequent clinical condition in normal children that may be complicated by community-acquired secondary peritonitis (CASP). We evaluated the potential efficacy of different drugs for initial treatment of this condition, as recommended by recent Consensus Conference and Guidelines for paediatric patients. Susceptibility to ampicillin-sulbactam, ertapenem, gentamycin, piperacillin, piperacillin-tazobactam, vancomycin, and teicoplanin was evaluated according to EUCST 2012 recommendations in aerobic bacteria isolated from peritoneal fluid in CASP diagnosed from 2005 to 2011 at 'Istituto Giannina Gaslini', Genoa, Italy. A total of 114 strains were analysed: 83 E. coli, 15 P. aeruginosa, 6 Enterococci, and 10 other Gram-negatives. Resistance to ampicillin-sulbactam was detected in 37% of strains, while ertapenem showed a potential resistance of 13% (all P. aeruginosa strains). However, the combination of these drugs with gentamicin would have been increased the efficacy of the treatment to 99 and 100%, respectively. Resistance to piperacillin-tazobactam was 3%, while no strain was resistant to meropenem. Our data suggest that monotherapy with ampicillin-sulbactam or ertapenem for community-acquired secondary peritonitis would present a non-negligible rate of failure, but the addition of gentamycin to these drugs could reset to zero this risk. On the contrary, monotherapy with piperacillin-tazobactam or meropenem is highly effective.

Topics: Ampicillin; Anti-Bacterial Agents; Bacterial Infections; beta-Lactams; Child; Community-Acquired Infections; Drug Resistance, Bacterial; Drug Therapy, Combination; Ertapenem; Gentamicins; Hospitals, Pediatric; Humans; Italy; Meropenem; Microbial Sensitivity Tests; Penicillanic Acid; Peritonitis; Piperacillin; Piperacillin, Tazobactam Drug Combination; Practice Guidelines as Topic; Sulbactam; Thienamycins

In recent years, owing to the presence of multi-drug resistant nosocomial bacteria, combination therapies are more frequently applied. Thus there is more need to investigate the in vitro activity of drug combinations against multi-drug resistant bacteria. Checkerboard synergy testing is among the most widely used standard technique to determine the activity of antibiotic combinations. It is based on microdilution susceptibility testing of antibiotic combinations. Although this test has a standardised procedure, there are many different methods for interpreting the results. In many previous studies carried out with multi-drug resistant bacteria, different rates of synergy have been reported with various antibiotic combinations using checkerboard technique. These differences might be attributed to the different features of the strains. However, different synergy rates detected by checkerboard method have also been reported in other studies using the same drug combinations and same types of bacteria. It was thought that these differences in synergy rates might be due to the different methods of interpretation of synergy test results. In recent years, multi-drug resistant Acinetobacter baumannii has been the most commonly encountered nosocomial pathogen especially in intensive-care units. For this reason, multidrug resistant A.baumannii has been the subject of a considerable amount of research about antimicrobial combinations. In the present study, the in vitro activities of frequently preferred combinations in A.baumannii infections like imipenem plus ampicillin/sulbactam, and meropenem plus ampicillin/sulbactam were tested by checkerboard synergy method against 34 multi-drug resistant A.baumannii isolates. Minimum inhibitory concentration (MIC) values for imipenem, meropenem and ampicillin/sulbactam were determined by the broth microdilution method. Subsequently the activity of two different combinations were tested in the dilution range of 4 x MIC and 0.03 x MIC in 96-well checkerboard plates. The results were obtained separately using the four different interpretation methods frequently preferred by researchers. Thus, it was aimed to detect to what extent the rates of synergistic, indifferent and antagonistic interactions were affected by different interpretation methods. The differences between the interpretation methods were tested by chi-square analysis for each combination used. Statistically significant differences were detected between the four diff

Topics: Acinetobacter baumannii; Acinetobacter Infections; Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Cross Infection; Drug Resistance, Multiple, Bacterial; Drug Synergism; Drug Therapy, Combination; Humans; Imipenem; Meropenem; Microbial Sensitivity Tests; Sulbactam; Thienamycins

A perfusion fluid used in the preservation of a grafted liver represents a medium suitable for microorganism growth. This study investigated the prevalence of perfusion fluid contamination, acute cellular rejection (ACR) episodes, and patient survival rate.. This is a retrospective study, based on an electronic database allocating cases of orthotopic liver transplantation. The exclusion criteria were as follows: having been submitted to multiple organ transplantation, liver retransplantation only, and those whose samples had not been collected or sent on the back table procedure or were unobtainable (usually the samples were sent when there was donor infection suspicion/positivity). Our posttransplantation infection prophylactic protocol consisted of ampicillin/sulbactam for 72 hours. The variables in the study were as follows: fluid contamination, presence of acute cellular rejection (ACR, Banff classification), and recipient survival at the first year. Statistical analysis was performed using descriptive statistics and chi-square with Fisher exact test considering significant P<.05.. We observed perfusion fluid contamination in 15/121 (12.39%). The agents were as follows: Klebsiella pneumoniae in 6 (4.96%), Staphylococcus epidermidis in 5 (4.13%), and Acinetobacter baumanii in 3 (2.48%) and negative cultures in 106 (87.60%). Only 1 patient had matching for donor infection and positivity hemoculture after the transplantation (K pneumoniae) and he was the only patient associated with fluid infection and death. The recipients who had their fluid preservation with positive cultures had more ACR and the survival rate was similar among those with or without infection.. Optimization of microbiological procedures can be performed including fungal and bacterial cultures.

Topics: Acute Disease; Ampicillin; Anti-Bacterial Agents; Antibiotic Prophylaxis; Bacterial Infections; Brazil; Chi-Square Distribution; Cross-Sectional Studies; Drug Administration Schedule; Drug Combinations; Graft Rejection; Graft Survival; Humans; Liver Transplantation; Microbiological Techniques; Organ Preservation Solutions; Perfusion; Retrospective Studies; Sulbactam; Survival Analysis; Survival Rate; Time Factors; Treatment Outcome

Ampicillin-sulbactam is guideline-recommended treatment for early-onset ventilator-associated pneumonia (VAP). However, intensive care unit clinicians are encountering increasing resistance to ampicillin-sulbactam. We sought to analyze the time period for early-onset VAP in our trauma population by using daily evaluation of resistance to ampicillin-sulbactam.. A retrospective cohort study was completed on all mechanically ventilated trauma patients admitted to a rural level-1 trauma center from January 2003 to December 2008 who were diagnosed with VAP. Daily bacterial resistance to ampicillin-sulbactam > 15% was defined as the threshold for early empiric antibiotic failure for the first episode of VAP. A univariate analysis of risk factors for multi-drug resistant pathogens (MDRPs) and comorbidities was completed to assess for predisposing factors for ampicillin-sulbactam resistance.. One hundred sixty-three pathogens were identified in 121 trauma patients diagnosed with VAP. Of these isolates, 71% were gram-negative, 28% were gram-positive, and 1% was fungal. Methicillin-susceptible Staphylococcus aureus (23.9%), H aemophilus influenzae (20.9%), and Pseudomonas aeruginosa (11.7%) were the most common infecting organisms. Daily ampicillin-sulbactam resistance was 40%, 26%, 32%, 43%, 50%, and 60% on days 3 to 7 and ≥ 8 days, respectively. Only the presence of MDRP risk factors (89% vs. 65%, p < 0.01) and hospital LOS (36.8 [22.8-49.0] vs. 25.7 days [19.0-32.5], p < 0.01) was different between ampicillin- sulbactam resistant and ampicillin-sulbactam susceptible VAP groups. On univariate analysis, hospital length of stay >4 days and antibiotic use within 90 days were associated with ampicillin-sulbactam resistant VAP (p < 0.01).. Ampicillin-sulbactam is not an effective empiric therapy for early-onset VAP in our rural trauma population. The utility of ampicillin-sulbactam should be reviewed at other institutions to assess for appropriate empiricism.

Topics: Adult; Aged; Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Drug Resistance, Multiple, Bacterial; Female; Guideline Adherence; Haemophilus Infections; Haemophilus influenzae; Humans; Intensive Care Units; Male; Microbial Sensitivity Tests; Middle Aged; Pneumonia, Staphylococcal; Pneumonia, Ventilator-Associated; Pseudomonas aeruginosa; Pseudomonas Infections; Staphylococcus aureus; Sulbactam; Wounds and Injuries

To evaluate the efficacy and cost of treatment with two beta-lactam/beta-lactamase-inhibitor combinations.. Retrospective, open-label multicenter study.. Fifty-four hospitals across the United States.. Eight hundred ninety patients with skin and soft tissue, intraabdominal, gynecologic, respiratory, urinary tract, or other infections that required parenteral antibiotic therapy.. Patients were administered either ampicillin-sulbactam 1.5 or 3.0 g every 6 hours or ticarcillin-clavulanate 3.1 g every 6 hours.. The agents did not differ significantly in efficacy for most infections; although, ampicillin-sulbactam was bacteriologically superior to ticarcillin-clavulanate in the treatment of intraabdominal infections (p=0.0011). Costs of ampicillin-sulbactam, particularly the 1.5-g dose, were lower than those of ticarcillin-clavulanate for skin and soft tissue (p<0.001), intraabdominal (p=0.005), and respiratory tract (p<0.001) infections.. Ampicillin-sulbactam provides effective coverage for patients with the above infections and is as effective as the broader-spectrum agent.

Topics: Adult; Aged; Ampicillin; Analysis of Variance; Bacterial Infections; Clavulanic Acids; Drug Costs; Drug Therapy, Combination; Female; Hospitalization; Humans; Male; Middle Aged; Retrospective Studies; Sulbactam; Ticarcillin; Treatment Outcome; United States

Topics: Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Drug Therapy, Combination; Humans; Penicillins; Sulbactam

Topics: Ampicillin; Anti-Bacterial Agents; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Humans; Infant; Penicillins; Sulbactam

The comparative efficacies of cefoxitin, cefotetan and the combination of ampicillin with sulbactam were investigated in mixed aerobic and anaerobic infections of mice. Treatment was administered by intramuscular injection for 10 days and was started 1 h before infection. After intraperitoneal infection with Escherichia coli, Bacteroides fragilis, and one other member of the B. fragilis group (either Bacteroides thetaiotaomicron, Bacteroides ovatus or Bacteroides distasonis), 41 of 90 (46%) control mice died and all survivors developed polymicrobial abscesses. Cephalosporin therapy reduced mortaligy 13% with cefoxitin, 3% with cefotetan, and 23% with ampicillin plus sulbactam; 14%, 10% and 14% of surviving animals, respectively developed abscesses. Each of the treatment regimens significantly reduced the number of all organisms in abscesses, independent of their activity in vitro. However, the reduction in the number of E. coli by ampicillin plus sulbactam was less marked (P < 0.001) than that achieved by cefoxitin (P < 0.05) or cefotetan. These data show that in vivo efficiencies of cefoxitin and cefotetan, are independent of their in vitro potencies in the early management of polymicrobial infections in mice.

Topics: Ampicillin; Animals; Bacterial Infections; Cefotetan; Cefoxitin; Drug Therapy, Combination; Male; Mice; Mice, Inbred C3H; Microbial Sensitivity Tests; Sulbactam

Topics: Ampicillin; Bacterial Infections; Colonic Diseases; Drug Therapy, Combination; Female; Humans; Male; Postoperative Complications; Stomach Diseases; Sulbactam; Surgical Wound Infection

Topics: Ampicillin; Bacterial Infections; Child; Drug Therapy, Combination; Female Urogenital Diseases; Humans; Male Urogenital Diseases; Sulbactam; Urinary Tract Infections

Topics: Ampicillin; Bacterial Infections; Drug Therapy, Combination; Humans; Jaw Diseases; Mouth Diseases; Sulbactam; Treatment Outcome

Topics: Ampicillin; Bacterial Infections; Drug Therapy, Combination; Humans; Sulbactam

Topics: Adolescent; Ampicillin; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Male; Sulbactam; Treatment Outcome; Urinary Tract Infections

Minimum inhibitory concentrations (MICs) were determined for sultamicillin (SBTPC), and for other major oral beta-lactam agents against clinically isolated strains collected from outpatients during a period from August, 1992 to February, 1993, and the following conclusions were obtained. 1. The ratio of penicillinase (PCase)-producing strains of Staphylococcus aureus was 96.0% and that of methicillin-resistant S. aureus (MRSA) was 12.0%. MIC90 of SBTPC against S. aureus including MRSA was 6.25 micrograms/ml. No increasing tendency was observed for S. aureus resistant to SBTPC. 2. No resistant strains were found among Streptococcus pyogenes and Enterococcus faecalis against penicillins (PCs) including SBTPC. But PCs and cephems (CEPs) insensitive or resistant Streptococcus pneumoniae were observed in 22.0% among all the strains of S. pneumoniae. 3. 100% of the tested both strains of Escherichia coli and Proteus mirabilis were beta-lactamase producers. 12.0% of the tested strains of Haemophilus influenzae and 16.0% of the strains of Neisseria gonorrhoeae were also beta-lactamase producers. SBTPC showed strong antimicrobial activity against most of these beta-lactamase producing strains. However, in our study of beta-lactamase productivity using plural substrates and test methods, it appeared that a part of strains of E. coli might produce beta-lactamase of "Extended broad-spectrum". MICs of SBTPC and CEPs against those strains were distributed rather in a high range. 4. The results of the study suggested that the resistant strains of S. pneumoniae against PCs and CEPs might be increasing year by year. Some of strains of E. coli, resistance against the 2 agents were observed. It is important to keep observing changes in resistance of such organisms in the future. 5. The antimicrobial activities of SBTPC against clinically isolated strains in this study indicated potential problems such as those mentioned above. It is, however, also confirmed that SBTPC shows still strong antimicrobial activities against most of beta-lactamase producing strains found in daily medical examinations. Taking into consideration of the strong activities of SBTPC against so-called indirect pathogenicity caused by beta-lactamase producing indigenous bacteria reported lately, SBTPC may be a useful antibiotic for community acquired infections in the 1990's.

Topics: Ampicillin; Bacteria; Bacterial Infections; beta-Lactamases; Drug Resistance, Microbial; Drug Therapy, Combination; Humans; Outpatients; Sulbactam

Topics: Ampicillin; Bacteria; Bacterial Infections; Child; Drug Therapy, Combination; Humans; Microbial Sensitivity Tests; Sulbactam

A total of 101 children (47 males, 54 females; age range, 3 months-16 years) with mild to moderate upper or lower respiratory tract infections, or skin and soft tissue infections entered a clinical study conducted at two centres in Izmir, Turkey. The children received a mean daily dose of 25 mg/kg sultamicillin oral suspension administered as two equal doses approximately 12 h apart. In total, 100 children met all requirements for evaluability and were included in the clinical efficacy assessment, and 49 children were evaluated for bacteriological efficacy. Clinical cure was reported by the investigators in 93 patients, improvement in six and failure in only one. The bacteriological eradication rate of isolated pathogens was 100%. Of the 101 patients evaluated for drug safety, four experienced adverse drug-related or possibly drug-related reactions. All side-effects were gastro-intestinal and diarrhoea was reported in three patients. No discontinuation of therapy was reported, nor were any significant laboratory abnormalities recorded.

Topics: Administration, Oral; Adolescent; Ampicillin; Bacterial Infections; Child; Child, Preschool; Connective Tissue Diseases; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Respiratory Tract Infections; Skin Diseases, Bacterial; Sulbactam; Suspensions

Oral tablets containing 375 mg sultamicillin were used to treat 30 adult patients of either sex suffering from lower respiratory tract infections. The dose used was one tablet every 12 h for 22 cases and one tablet every 8 h for eight cases. The duration of therapy varied between 5 and 14 days (mean 8.6 days). The therapeutic response was rated as cure in 23 (76.6%) patients, with complete disappearance of pretreatment signs and symptoms, and as improvement in seven (23.3%) patients, with amelioration of the pretreatment manifestations. All 52 microorganisms isolated before treatment were eradicated. No adverse effects were reported in 25 (83.3%) patients, whereas the remaining five (16.7%) patients reported mild loose stools with normal bowel motion. There were no abnormal changes in blood count and liver and renal functions following sultamicillin treatment.

Topics: Acute Disease; Administration, Oral; Adult; Ampicillin; Bacterial Infections; Bronchitis; Chronic Disease; Drug Therapy, Combination; Female; Humans; Male; Pneumonia; Respiratory Tract Infections; Sulbactam; Tablets

A total of 40 adult females were studied suffering from different obstetric and gynaecological infections. In 30 patients two 375 mg sultamicillin tablets were taken twice daily, whereas 10 patients received one 375 mg sultamicillin tablet twice daily. The duration of treatment ranged from 5 to 12 days, with a mean of 6.6 days. Cure or improvement was reported in 35 (87.5%) cases, whereas five (12.5%) patients did not respond to therapy. Of the 61 pathogens isolated before treatment, 56 (91.8%) were eradicated. Clinical tolerability of the therapy was excellent, with no adverse effects being observed in any of the studied patients. The absence of significant differences between the mean values of blood count, hepatic and renal function tests performed before and after treatment confirmed the safety of treatment. It is concluded that sultamicillin is a suitable and useful additional antibiotic therapy for the treatment of obstetric and gynaecological bacterial infections.

Topics: Administration, Oral; Adolescent; Adult; Aged; Ampicillin; Bacterial Infections; Drug Administration Schedule; Drug Therapy, Combination; Female; Genital Diseases, Female; Humans; Middle Aged; Premedication; Sulbactam

The authors treated 24 children, the majority with respiratory infections and infections of the urinary tract, with sultamicillin, incl. 22 where an oral suspension was used and in two children therapy was started with i.v. administration of Unasyn, followed by administration of the suspension. The children tolerated the drug very well and the therapeutic results were good.

Topics: Ampicillin; Bacterial Infections; Child; Child, Preschool; Drug Therapy, Combination; Humans; Infant; Sulbactam

Topics: Adolescent; Adult; Ampicillin; Bacteria; Bacterial Infections; Child; Child, Preschool; Drug Evaluation; Drug Therapy, Combination; Humans; Infant; Microbial Sensitivity Tests; Platelet Count; Sulbactam; Time Factors

Topics: Administration, Oral; Ampicillin; Bacterial Infections; Bacteriological Techniques; Child; Child, Preschool; Drug Administration Schedule; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

The clinical and bacteriological efficacy of a sulbactam/ampicillin combination was compared with piperacillin in a group of 50 patients suffering from acute or chronic lower respiratory infections: 26 were treated intravenously with piperacillin and 24 with sulbactam/ampicillin. The treatment was continued for at least 7 days for 24 patients at the dosage of 3 g sulbactam/ampicillin twice daily, for a further 24 patients at the dosage of 6 g piperacillin twice daily and for two patients at the dosage of 8 g piperacillin twice daily. In the patients treated with sulbactam/ampicillin, a rapid decrease in the fever with the concomitant reduction in cough and sputum production was observed, with cure in 18 cases and improvement in six. In the patients treated with piperacillin cure was observed in 14 cases and improvement in 12 cases. In both treatment groups safety was excellent. There was no significant difference, either in effectiveness or tolerability, between the two groups.

Topics: Adolescent; Adult; Aged; Ampicillin; Bacterial Infections; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Piperacillin; Respiratory Tract Infections; Sulbactam

The importance of beta-lactamase-producing strains in acute otitis media and acute/chronic sinusitis, and the effectiveness of sulbactam/ampicillin were ascertained in vitro and in vivo. Of the strains isolated from 19 patients with otitis media, 40% are beta-lactamase producers whereas 44% of strains isolated from 22 patients with sinusitis produced beta-lactamase. When the most commonly isolated strains were treated with a range of antibiotics in vitro, they all showed 100% sensitivity to sulbactam/ampicillin. The clinical results for otitis media showed 63% recovery and 26% improvement, with only one (5%) failure (one patient did not complete treatment). For sinusitis the results were 55% recovery and 45% improvement, and no failures. For sinusitis, the end-of-treatment microbiological results showed complete eradication of the pathogens responsible for infection. The results indicate that sulbactam/ampicillin is an effective treatment for infections of the ear, nose and throat.

Topics: Adolescent; Adult; Ampicillin; Bacteria; Bacterial Infections; beta-Lactamases; Drug Resistance, Microbial; Drug Therapy, Combination; Humans; In Vitro Techniques; Middle Aged; Otitis Media; Sinusitis; Sulbactam

Estimates were carried out on the clinical and bacteriological efficacy of an intramuscular combination of sulbactam/ampicillin, together with an assessment of its tolerability and safety in the treatment of gynaecological and obstetric infections. A total of 30 women with pelvic inflammatory disease, wound infections, vaginitis and puerperal sepsis received an intramuscular combination of sulbactam/ampicillin in a total daily dose of 1.5 g for between 3 and 7 days. Clinical cure and improvement were achieved in 27 (90%) cases but there was no response in three (10%) cases. No side-effects were seen in 29 (97%) cases, whereas tolerable local injection site pain was reported in one case. The safety of the sulbactam/ampicillin antibiotic combination was evident in all the cases studied, as there was no significant difference between the means of laboratory tests before and after therapy of blood and renal measures.

Topics: Adult; Ampicillin; Bacterial Infections; Drug Therapy, Combination; Female; Genital Diseases, Female; Humans; Injections, Intramuscular; Sulbactam

A prospective audit of 644 patients undergoing biliary tract operations has been conducted in ten district general hospitals. All patients received a single dose of ampicillin 2 g and sulbactam 1 g as antibiotic prophylaxis. Bacteria were cultured from the bile of 121 patients. In patients with sterile bile the incidence of postoperative infection was 2.5%, while in those with colonized bile it was 22% (P less than 0.0001). The 35 patients from whose bile bacteria of two or more species were isolated, had a higher incidence of wound infection (34%) than those whose bile yielded only one species of bacterium (17%; P less than 0.05). Seventeen of the 27 patients with colonized bile who developed postoperative infection were shown to be infected by the same organisms that had been isolated from their bile. The patients whose bile yielded organisms resistant to the prophylactic antibiotic combination did not have a significantly higher rate of infection than those from whose bile only sensitive organisms were obtained. A marked difference in sensitivity patterns between the participating hospitals was observed.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ampicillin; Bacterial Infections; Biliary Tract Surgical Procedures; Cross Infection; Drug Resistance, Microbial; Drug Therapy, Combination; Enterobacteriaceae; Enterococcus faecalis; Female; Humans; Male; Middle Aged; Postoperative Complications; Premedication; Prospective Studies; Risk Factors; Sulbactam

20 patients with moderately severe bacterial infections were studied to determine the clinical efficacy and safety of parenteral sulbactam/ampicillin. There were 9 female and 11 male patients. Their mean age was 51 years. 8 patients had pneumonia, 5 urinary tract infection, 4 cellulitis of the leg and 3 had pustular tonsillitis. 85% of patients had resolution of fever and symptoms within 48 hours of commencing treatment. 95% had successful treatment outcome. The organisms isolated included E. Coli, Klebsiella sp, Branhamella catarrhalis and Bacillus species. In 2 patients, the organisms isolated demonstrated in-vitro ampicillin resistance. However, they recovered fully with sulbactam/ampicillin therapy. No adverse side-effects were reported and dosage adjustment was not required in the elderly.

Topics: Adult; Aged; Ampicillin; Bacterial Infections; Drug Therapy, Combination; Female; Humans; Male; Middle Aged; Sulbactam

Sultamicillin (SBTPC) is a mutual prodrug of sulbactam (SBT) and ampicillin (ABPC). A study has been performed to evaluate pharmacokinetic properties and clinical usefulness of SBTPC fine granules in the treatment of pediatric infections. After an oral dose of 5-15 mg/kg of SBTPC fine granules, peak serum concentrations of ABPC and SBT were 1.18-3.26 micrograms/ml and 0.97-3.05 micrograms/ml, respectively at 1 hour. Serum half-lives for elimination (T 1/2 (beta] of ABPC and SBT were 0.83-1.83 hours and 0.94-1.71 hours, respectively. Serum concentrations of ABPC at 1-6 hours after an oral administration of SBTPC fine granules were similar to those of SBT. Serum concentrations of ABPC and SBT were proportional to dose levels of SBTPC fine granules. Following oral administrations of 5-15 mg/kg, 33.9-64.8% of ABPC and 38.1-76.6% of SBT were recovered in urine in 6 hours. SBTPC fine granules were administered in a daily dose of approximately 30 mg/kg divided into 3 doses to 14 pediatric patients with bacterial infections. All 14 were cured with 11 excellent and 3 good clinical response to this drug. Microbiological eradication was obtained in 85.7%. beta-Lactamase-producing ABPC-resistant strains were eradicated. Adverse effects including laboratory test values that may be attributed to the administration of SBTPC fine granules were not observed except a treatment episode of diarrhea in 1 patient.

Topics: Adolescent; Age Factors; Ampicillin; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

Sultamicillin fine granules (SBTPC), a mutual prodrug of sulbactam (SBT) and ampicillin (ABPC), were administered to 16 pediatric patients with bacterial infections. The efficacy rate was 93.3%. MICs (10(6) cells/ml) of SBTPC against beta-lactamase non-producing strains were not significantly different from those of ABPC, and ranged from less than or equal to 0.05 to 1.56 micrograms/ml. MICs of SBTPC, however, were 2-4 fold smaller than MICs of ABPC against beta-lactamase producing strains. Diarrhea and loose stool as side effects were observed in 4 (25%) of 16 patients, but none of them were severe. After oral administration of SBTPC (10 mg/kg), serum levels of ABPC and SBT peaked at 3.41 micrograms/ml and 2.43 micrograms/ml after 0.6 hour, and declined with half-lives of 1.79 and 1.00 hours, respectively.

Topics: Age Factors; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Humans; Infant; Sulbactam

Clinical studies were carried out on sultamicillin (SBTPC) fine granule in the field of pediatrics. The results obtained are summarized below. 1. Thirty children with bacterial infections were treated with SBTPC fine granule. The clinical results were excellent in 24 and good in 5, with an efficacy rate of 96.7%. 2. Bacteriological screening identified 26 pathogenic organisms of which 14 were Gram-positive cocci and 12 Gram-negative rods. Eradication rates were 91.7% in Gram-positive cocci and 66.7% in Gram-negative rods. 3. As side effects, diarrhea was observed in 12.9%, loose stool in 16.1% and eosinophilia in 3.2% of the patients. From the above results, it appeared that SBTPC fine granule was a useful drug for treating bacterial infections in the field of pediatrics.

Topics: Adolescent; Age Factors; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Infant, Newborn; Male; Sulbactam

Pharmacokinetic and clinical studies on sultamicillin (SBTPC) were carried out in the field of pediatrics. 1. Absorption and excretion. A crossover study with a single oral administration of 10 mg/kg of SBTPC in fasting and after meal, and that with 10 mg/kg and 20 mg/kg of SBTPC after meal were carried out in 11 children (5-15 years) and in 6 children (8-15 years), respectively. Serum levels and urinary excretion of sulbactam (SBT) and ampicillin (ABPC) were determined. Mean serum concentrations of ABPC after oral administration of 10 mg/kg of SBTPC with in fasting or after meal, in the former study, peaked at 4.75 +/- 1.97 micrograms/ml in 1 hour and declined with a mean half-life of 0.81 +/- 0.18 hour and the mean serum concentration of ABPC at 6 hours after administration was 0.06 +/- 0.07 micrograms/ml. Mean serum concentration of ABPC study in the latter peaked at 2.95 +/- 0.79 micrograms/ml in 1 hour, and declined with a mean half-life of 1.35 +/- 0.43 hours, and the mean serum concentration of ABPC at 6 hours was 0.22 +/- 0.13 microgram/ml. Mean urinary recovery rates of ABPC in 6 hours after administration were 54.5 +/- 17.6% in the former study, and 63.2 +/- 14.3% in the latter. These results suggested a delay of absorption with meal. Mean serum concentrations of ABPC after oral administration of 10 mg/kg or 20 mg/kg of SBTPC after meal, in the former study, were 3.10 +/- 0.72 micrograms/ml at 1 hour and declined with a half-life of 1.22 +/- 0.32 hours, and those of ABPC were 0.22 +/- 0.12 microgram/ml at 6 hours, and they were 6.46 +/- 1.57 micrograms/ml, 1.48 +/- 0.51 hours and 0.55 +/- 0.40 microgram/ml, respectively in the latter study. Mean urinary recovery rates of ABPC in 6 hours, were 50.4 +/- 10.2% in the former study and 57.7 +/- 11.4%, in the latter. A dose response was observed with time course of mean serum concentrations. Mean serum concentrations of SBT were lower than those of ABPC, and they declined in a similar manner. The mean urinary recovery rate of SBT was similar or lower than that of ABPC. 2. Clinical study SBTPC was used for the treatment of a total of 38 pediatric patients with ages 6 months to 11 years and it's clinical effectiveness, bacteriological efficacy and adverse effects were evaluated.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Administration, Oral; Adolescent; Age Factors; Ampicillin; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Male; Sulbactam

Pharmacokinetic, bacteriological and clinical studies on sultamicillin (SBTPC) fine granule were carried out in the field of pediatrics. The results obtained are summarized as follows. 1. Antibacterial activities of SBTPC against clinically isolated strains of Haemophilus influenzae, Haemophilus parainfluenzae, Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus agalactiae, Staphylococcus aureus, Branhamella catarrhalis, and Escherichia coli were compared with those of ampicillin (ABPC). SBTPC was superior to ABPC especially against beta-lactamase producing H. influenzae, E. coli, S. aureus, and B. catarrhalis. 2. Serum concentrations and urinary excretion rates of sulbactam (SBT) and ABPC after administration of SBTPC fine granule at a dose level of 10 mg/kg in 2 cases were determined. Mean half-lives of SBT and ABPC in the serum following oral administration were about 1.33 and 1.61 hours respectively. Mean urinary recovery rates of SBT and ABPC in 6 hours after oral administration at a dose of 10 mg/kg were 58.7% and 49.6% respectively. 3. SBTPC fine granule was administered to 20 pediatric patients with various bacterial infections (pneumonia 8 cases, bronchitis 2, pharyngitis 2, tonsillitis 4, subcutaneous abscess 1 and urinary tract infection 3). The overall clinical efficacy rate was 100% and the overall bacteriological eradication rate was 75%. 4. No adverse reactions were observed except 1 case of loose stool. No abnormal laboratory test values were observed. These results indicate the usefulness of SBTPC fine granule in the treatment of bacterial infections in children.

Topics: Adolescent; Age Factors; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

Sultamicillin (SBTPC) is a combination drug of sulbactam (SBT) and ampicillin (ABPC) in an ester bonding at 1:1 ratio. SBT, a new semisynthetic beta-lactamase inhibitor restores and extends the spectrum of ABPC against resistant strains of bacteria. SBTPC granules were administered to 26 pediatric patients with infections, and clinical efficacies were studied in 23 patients. The clinical efficacy rate was 95.7% and the drug was evaluated to be highly effective for the treatment of infectious diseases in the pediatric field. SBTPC was safe and well tolerated.

Topics: Age Factors; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

The clinical efficacy and the safety of sultamicillin (SBTPC) fine granules, which is a semisynthetic beta-lactam antibiotic for oral use with ester linked ampicillin (ABPC) and sulbactam (SBT), a beta-lactamase inhibitor, in a ratio of 1:1, were evaluated in 31 patients with ages from 6 months old to 10 years and 4 months old with various bacterial infections. The results obtained are summarized as follows. 1. In a pharmacokinetic study with a dose level of 10 mg/kg SBTPC, serum levels reached a peak in 1 hour after oral administration, with peak levels of 3.94 micrograms/ml for ABPC and 4.08 micrograms/ml for SBT. Half-lives of ABPC and SBT were 64.8 minutes and 63.6 minutes, respectively. The urinary excretion of ABPC over 6 hours was 66.2% and that of SBT was 60.4%. 2. SBTPC fine granules were administered orally to 1 patient with bronchitis, 9 patients with bronchopneumonia, 7 patients with tonsillitis, 4 patients with scarlet fever, 1 patient each with pharyngitis, otitis media, purulent parotitis, and urinary tract infection and 6 patients with skin and soft tissue infections at daily dosage levels of 26.1-31.6 mg/kg divided into 3 or 4. Clinical evaluations of these 31 patients were as follows, excellent: 20 patients, good: 10 patients, poor: 1 patient. The efficacy rate was 96.8%. 3. Diarrhea was observed in a patient with otitis media on the fifth day of SBTPC administration. No other clinical adverse reaction was observed in any of the remaining 30 patients. No abnormal laboratory data was found in any of 23 patients who were subjected to laboratory examinations for safety.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Age Factors; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

We have carried out laboratory and clinical studies on sultamicillin (SBTPC). The results are summarized as follows. SBTPC was given by oral administration to 2 children in a single dose at 5 mg/kg and to 3 children in a single dose at 10 mg/kg. After the oral administration, mean peak serum levels of ampicillin (ABPC) and sulbactam (SBT) obtained for the 2 dose levels were 1.91 +/- 1.34 and 2.06 +/- 1.06 micrograms/ml and 2.43 +/- 0.68 and 2.96 +/- 0.77 micrograms/ml at 1 hour, respectively, and mean half-lives were 0.80 +/- 0.10 and 0.98 +/- 0.46 hour and 1.57 +/- 0.57 and 2.01 +/- 0.70 hours, respectively. SBTPC was given to 2 children in a single dose at 15 mg/kg. After oral administration, the mean serum levels of ABPC and SBT at 30 minutes were 6.55 +/- 1.63 and 6.00 +/- 1.00 micrograms/ml, and the mean half-lives were 0.90 +/- 0.13 and 0.82 +/- 0.16 hour. SBTPC was given to 1 child at a single dose of 20 mg/kg. The peak serum levels of ABPC and SBT were 11.3 and 8.64 micrograms/ml, and the half-lives were 0.87 and 0.92 hour. Mean urinary excretion rates of ABPC and SBT were 38.4 +/- 2.7 and 34.6 +/- 4.7%, 43.0 +/- 3.6 and 41.6 +/- 5.8%, 47.7 +/- 5.2 and 51.6 +/- 3.5% in 6 hours and 66.1 and 59.2% in 8 hours after oral administration of 5 mg/kg, 10 mg/kg, 15 mg/kg and 20 mg/kg, respectively. Treatment with SBTPC was made in 34 cases of pediatric bacterial infections; 2 cases of pharyngitis, 19 cases of tonsillitis, 2 cases of bronchitis, 3 cases of impetigo, 2 cases of staphylococcal skalded skin syndrome, 4 cases of urinary tract infection and 1 case each of pneumonia and scarlet fever. Results obtained were excellent in 20 cases, good in 13 cases and poor in 1 case. No significant side effect due to the drug was observed in any cases.

Topics: Age Factors; Ampicillin; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Staphylococcal Skin Infections; Sulbactam

Sultamicillin (SBTPC), a mutual prodrug for ampicillin (ABPC) and beta-lactamase inhibitor sulbactam (SBT), was evaluated for its antibacterial activity, pharmacokinetics and clinical efficacy. Pharmacokinetic studies were done in 2 subjects (a male and a female) following single oral administrations of 5 mg/kg and 10 mg/kg SBTPC fine granules after meal. Peak serum concentrations of ABPC and SBT in the 2 cases were 0.85 and 0.38 micrograms/ml and 3.74 and 3.79 micrograms/ml, respectively. Urinary excretion rates in 6 hours were 43.5-58.1% for ABPC and 33.6-53.6% for SBT. A total of 20 patients including 14 with respiratory infections, 1 with urinary tract infection and 5 with skin and soft tissue infections were treated with daily oral dose of 15.4-39.3 mg/kg SBTPC fine granules t.i.d. for 4 to 13 days. Responses were excellent in 5, good in 13 and fair in 2, hence the overall efficacy rate was 90.0%. Bacteriological responses were confirmed on 5 (62.5%) out of 8 strains which were eradicated by the treatment. SBTPC showed strong antibacterial activities against an ABPC-resistant strain of Escherichia coli. Side effects of the drug were observed in 3 patients: diarrhea in 2 and loose stool in 1. An abnormal laboratory test value, eosinophilia, was observed in only one patient.

Topics: Adolescent; Age Factors; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

Sultamicillin, a mutual prodrug of a beta-lactam antibiotic and beta-lactamase inhibitor, was administered to 19 child patients with infectious diseases. The patients included 9 boys and 10 girls from 11 months to 13 years old and they were given orally a dosage of 15.4-40.8 mg/kg/day for 3 to 12 days. Clinical efficacies were excellent in 2 cases, good in 13 cases, fair in 3 cases, unknown in 1 case, and the total efficacy rate was 83.3%. Loose stool in 1 case and mild diarrhea in another occurred as side effects of the drug, but no abnormal laboratory test values were found upon the treatment.

Topics: Administration, Oral; Adolescent; Age Factors; Ampicillin; Bacteria; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

Pharmacokinetics, safety and effects on bacterial infection of sultamicillin (SBTPC) fine granule were evaluated in 17 children. The results obtained are summarized as follows. 1. Pharmacokinetics in 3 children receiving a single dose of 10 mg per kg body weight were evaluated. The half-life of ampicillin (ABPC) was 1.38 +/- 0.14 hours and that of sulbactam was 0.93 +/- 0.26 hour. 2. Fourteen cases, including 7 tonsillitis, 2 pharyngitis, 2 bronchitis, and 1 each of cystitis, scarlet fever and cellulitis were treated with SBTPC fine granule. The clinical efficacy rate was 100%. 3. Bacteriological efficacies classified by causative organisms were evaluated in 5 children. Staphylococcus aureus was responsible in 3 cases, Streptococcus pyogenes in 1 case, Escherichia coli and Proteus mirabilis in 1 case. Eradication rate was 100%. SBTPC was more active than ABPC against ABPC-resistant strains and almost equal to or more active than cephalexin or cefaclor. 4. The only abnormal laboratory test value observed was eosinophilia in 2 children. No side effects were recorded. From the above results it is concluded that SBTPC fine granule is one of first choices of effective, useful and safe antibiotics for the treatment of infections in pediatric field.

Topics: Age Factors; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Child; Child, Preschool; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

We have evaluated sultamicillin (SBTPC) fine granules for pharmacokinetics and therapeutic effectiveness in children. The results are summarized as follows. 1. Pharmacokinetic parameters after the oral administration of single dose of 5.0 mg per kg body weight in 1 child were as follows: The peak serum concentrations of ampicillin (ABPC) and sulbactam (SBT) were 1.92 micrograms/ml at 1 hour and 1.85 micrograms/ml at 1 hour, respectively. The half-lives in serum and urinary excretion rate for ABPC and SBT were similar. 2. A clinical study was performed on 15 children with infections, including 4 with tonsillitis, 5 with pharyngitis, 2 each with bronchitis, cystitis, and urinary tract infections. Doses ranging from 6.7 to 18.2 mg/kg body weight were given tid. or qid. Lengths of treatment ranged from 5 to 10 days. The therapeutic responses were considered "excellent" in 6 and "good" in 9, with an effectiveness rate of 100%. 3. As to side effects of the drug, diarrhea was observed in 1 patient. It was concluded that SBTPC was a promising drug for the treatment of bacterial infections in children.

Topics: Administration, Oral; Age Factors; Ampicillin; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

Sultamicillin (SBTPC) is a combined drug of ampicillin (ABPC) and sulbactam (SBT) which is an inhibitor of beta-lactamase, in a clinical form of tosylate with equivalent molecules in ester linkages. A tablet form of this combined drug has been released since July, 1987 in Japan and now a granular form for pediatric patients has been developed. Hence, the granular form of SBTPC was administered to 6 boys (age: 8 years 5 months-11 years 5 months) to determine plasma and urinary concentrations of the drug and its urinary recovery-rates. The dose of 10 mg/kg or 15 mg/kg was given orally just after meal to 3 boys. To study clinical and bacteriological effects of this drug, a mean daily dose of 27.1 mg/kg divided 2-4 times a day was administered for 9 days on the average to a total of 57 cases with pharyngitis (5), tonsillitis (5), laryngitis (1), bronchitis (1), pneumonia (8), scarlet fever (1), typhoid fever (1), impetigo (16), furuncle (2), abscess (6), lymphadenitis (1) and urinary tract infection (10) except 2 cases which were unevaluable for clinical effects. MICs of 7 drugs (SBTPC, ABPC, SBT, methicillin (DMPPC), cloxacillin (MCIPC), cephalexin and cefaclor) against 12 of 22 strains isolated from patients with infections of skin and soft tissue were determined with inoculum-sizes of 10(8) and 10(8) CFU/ml to study beta-lactamase producing activities. Adverse reactions and abnormal effects on laboratory test values attributable to this drug were studied in patients including dropped-out cases. The results obtained are summarized as follows. 1. Mean plasma peak levels of ABPC and SBT were observed at 1 hour after administration in both of the 10 mg/kg and the 15 mg/kg groups with values of 2.34 and 5.57 micrograms/ml for ABPC and 1.87 and 4.66 micrograms/ml for SBT, respectively. Mean concentrations of SBT were lower than those of ABPC in both groups and individuals. Dose-responses in plasma levels and AUCs were observed in both groups. Mean half-life values of ABPC and SBT in the 2 groups were 1.93 and 1.12 hours for ABPC and 1.97 and 1.22 for SBT, respectively. Mean half-life values for ABPC and SBT were similar in each group and this tendency was also seen among individuals.(ABSTRACT TRUNCATED AT 400 WORDS)

Topics: Adolescent; Age Factors; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Child; Child, Preschool; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

Sultamicillin (SBTPC) is a semi-synthesized beta-lactam antibiotic consisted of ampicillin (ABPC) and a beta-lactamase inhibitor, sulbactam (SBT), linked with an ester linkage. Pharmacokinetic and clinical studies using SBTPC 10% fine granules were performed in pediatric patients with a variety of infections. 1. Pharmacokinetic investigation: SBTPC was given at 30 minutes after meal at a dose of 10 mg/kg. Peak serum levels were attained at 1 hour after dosing with average levels of 3.83 +/- 0.27 micrograms/ml for ABPC and 2.73 +/- 0.30 micrograms/ml for SBT. The average half-life of ABPC was 1.52 +/- 0.25 hours and that of SBT was 1.13 +/- 0.09 hours. The urinary recovery rate of ABPC during 6 hours after dosing was 58.2 +/- 4.9% and that of SBT was 59.7 +/- 6.4%. 2. Clinical investigation: Enrolled in the study were a total of 26 patients including 12 with tonsillitis, 6 with pharyngitis, 5 with urinary tract infections, and 1 each with bronchitis, with Salmonella enteritis and a case with fever of unknown case. Responses were excellent in 15 patients, good in 8, fair in 2 and poor in 1 with an efficacy rate of 88.5%. In the assessment of the bacteriological efficacy, 11 out of 14 strains of organisms isolated previous to the treatment were eradicated, 1 strain was found reduced in number and 2 strains remained unchanged with an eradication rate of 78.6%. One patient (3.8%) out of the 26 had diarrhea as side effects and 3 patients (16.7%) of 18 showed eosinophilia in laboratory examinations.

Topics: Adolescent; Age Factors; Ampicillin; Bacterial Infections; Child; Child, Preschool; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Female; Humans; Infant; Male; Sulbactam

This study was performed to evaluate the clinical efficacy and the safety of sultamicillin (SBTPC) fine granules in the treatment of patients with meibomianitis. A dose of 375 mg SBTPC granules was orally given to 10 patients with meibomianitis after each meal, three times a day. The results obtained are summarized as follows. Efficacies were rated as good in 7 cases, fair in 2 and poor in 1 with an efficacy ratio of 70.0%. No side effects were observed throughout the study. The organisms isolated were Gram-positive bacteria such as Staphylococcus aureus, Staphylococcus epidermidis, coagulase negative Staphylococcus and Streptococcus sanguis, and Gram-negative bacteria such as Alcaligenes denitrificans subsp. denitrificans, Alcaligenes denitrificans subsp. xylosoxidans, Xanthomonas maltophilia and Acinetobacter lwoffii. A bacteriological study showed lower MICs of SBTPC than those of ampicillin (ABPC), suggesting that SBTPC has more potent antibacterial activity than ABPC. Such bacteriological activity of SBTPC was well reflected in its clinical efficacy; the drug was effective in patients with infections caused by organisms moderately or highly resistant to ABPC or cefaclor.

Topics: Administration, Oral; Adult; Aged; Ampicillin; Ampicillin Resistance; Bacteria; Bacterial Infections; Dosage Forms; Drug Evaluation; Drug Therapy, Combination; Eyelid Diseases; Female; Humans; Meibomian Glands; Middle Aged; Sulbactam

Effects of sultamicillin (SBTPC) fine granules, a new oral beta-lactam antibiotic, on the intestinal bacterial flora were studied in tetra-contaminated mice and in pediatric patients. SBTPC was administered at a dose of 100 mg/kg once a day for 5 consecutive days to mice contaminated with 4 different species of organisms: Escherichia coli, Enterococcus faecalis, Bacteroides fragilis and Bifidobacterium breve. In all of the 4 species, bacterial populations in feces were markedly reduced on days 4 to 5 after the start of the treatment. Subjects in the pediatric study were 5 children with bacterial infections (4 boys and 1 girl) at ages from 1 year 3 months to 10 years 8 months and with their body weight ranging from 11.8 kg to 35.0 kg. SBTPC fine granule was administered at a dose of 10 mg/kg 3 to 4 times a day for 4 to 7 days. Although there were some variations in the fecal bacterial flora noticed among these subjects during the treatment, populations of main aerobes and anaerobes such as Enterobacteriaceae, Enterococcus, Bacteroides and Bifidobacterium decreased markedly in all cases. These decreases were more pronounced for anaerobes and total numbers of anaerobes were markedly reduced in all cases. Glucose non-fermenting Gram-negative rods and fungi tended to increase with administration of SBTPC fine granule. Although these changes tended to return to pre-dosing state after the cessation of the treatment with SBTPC fine granule, attention must be paid to possible occurrences of diarrhea, superinfection or bleeding tendency when treatment with the drug is continued for a long period of time. Fecal concentrations of both ampicillin and sulbactam during SBTPC fine granule treatment showed relatively high values except 1 sample with a high beta-lactamase activity in feces. These high concentrations suggest the possibility of biliary excretion of absorbed drugs and the possibility of hydrolysis of SBTPC in the intestine due to high pH. Fecal concentrations of the drug also appeared to be closely related to beta-lactamase activity in feces.

Topics: Ampicillin; Ampicillin Resistance; Animals; Bacteria; Bacterial Infections; beta-Lactamases; Child; Child, Preschool; Colony Count, Microbial; Drug Therapy, Combination; Feces; Humans; Infant; Intestines; Male; Mice; Sulbactam

Sulbactam is a new beta-lactamase inhibitor with pharmacokinetic characteristics in humans similar to those of ampicillin. A total of 41 patients hospitalized in the Clinic of Infectious Diseases, University of Naples, for chronic liver diseases, were treated with sulbactam/ampicillin (ratio 1:2) for urinary, respiratory, biliary tract or soft tissue infections. Sulbactam/ampicillin was administered im or iv at a dosage of 3-9 g/day depending on the site and severity of the infection. All the patients treated with sulbactam/ampicillin had clinical signs and symptoms of infection, and all the organisms isolated were sensitive to sulbactam/ampicillin (MIC less than 16 mg/l). For both Gram-positive and Gram-negative bacteria the sulbactam/ampicillin MICs were much lower than the ampicillin MICs. In agreement with the favourable in-vitro results, we observed good therapeutic efficacy. 85% of the patients recovered or improved within a few days of therapy, with no clinical relapses, and in 81% of the infections the responsible bacteria were completely eradicated. We observed a low number of side effects (3/41 oral candidosis; 3/41 pain at the im injection site) and no change in the blood chemistry tests.

Topics: Adult; Aged; Aged, 80 and over; Ampicillin; Bacterial Infections; beta-Lactamase Inhibitors; Chronic Disease; Drug Combinations; Female; Gram-Negative Bacteria; Gram-Positive Bacteria; Humans; Liver Diseases; Liver Function Tests; Male; Microbial Sensitivity Tests; Middle Aged; Penicillanic Acid; Sulbactam

Topics: Ampicillin; Bacterial Infections; beta-Lactamase Inhibitors; Drug Combinations; Humans; Kinetics; Microbial Sensitivity Tests; Penicillanic Acid; Sulbactam