sultamicillin and Skin-Diseases--Bacterial

Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.. In this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196).. In the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group.. Tigecycline was generally safe and effective in the treatment of cSSSIs.. ClinicalTrials.gov NCT00368537.

Topics: Adult; Aged; Amoxicillin-Potassium Clavulanate Combination; Ampicillin; Anti-Bacterial Agents; Female; Humans; Male; Middle Aged; Minocycline; Skin Diseases, Bacterial; Skin Diseases, Infectious; Sulbactam; Tigecycline

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

Pediatric skin and skin structure infections are often polymicrobial and require empiric therapy effective against pathogens that may be resistant to many antimicrobial agents. The present study tested the efficacy and safety of a parenteral beta-lactam/beta-lactamase inhibitor combination, ampicillin/sulbactam, and a beta-lactamase-stable cephalosporin, cefuroxime, in serious pediatric skin and skin structure infections requiring hospitalization and parenteral antimicrobial therapy.. This was a multicenter, randomized, prospective, comparative open label trial that enrolled patients 3 months through 11 years of age. Patients received 150 to 300 mg/kg/day ampicillin/sulbactam in equally divided intravenous doses every 6 h. Cefuroxime was given in a dosage of 50 to 100 mg/kg/day either intravenously or intramuscularly in equally divided doses every 6 or 8 h. Maximum treatment was not to exceed 14 days. Patients could receive subsequent oral antimicrobial treatment at the investigator's discretion.. At final evaluation for clinical efficacy, 78.0% (n = 46) of the 59 evaluable patients who received ampicillin/sulbactam were cured and 22.0% (n = 13) were improved. The respective values for the 39 evaluable patients treated with cefuroxime were 76.9% (n = 30) and 23.1% (n = 9). At the end of treatment all pathogens were eradicated from 93.2% (n = 55) of 59 patients treated with ampicillin/sulbactam and from 100% of 39 who received cefuroxime. There were no significant differences between treatments in clinical or bacteriologic efficacy. Both ampicillin/sulbactam and cefuroxime were well-tolerated.. Both ampicillin/sulbactam and cefuroxime provide safe and effective parenteral antibiotic therapy in pediatric patients with serious skin and skin structure infections.

Topics: Ampicillin; Cefuroxime; Cephalosporins; Child; Child, Preschool; Drug Therapy, Combination; Female; Humans; Infant; Male; Prospective Studies; Skin Diseases, Bacterial; Sulbactam; Treatment Outcome

Anthrax is a rare disease caused by Bacillus anthracis. Antrax is zoonotic disease and is often encountered in persons engaged in animal husbandry. Cutaneous anthrax is approximately 95% of anthrax in humans. Palbebral involvement is rare.. In this study, we aimed to evaluate the clinical presentation, diagnosis and treatment of cases with cutaneous palpebral anthrax.. In this study, the patients diagnosed of cutaneous palpebral anthrax between January 2000 and December 2012, were investigated and evaluated, retrospectively. Cutaneous palpebral anthrax was diagnosed by the presence of typical anthrax lesion and/or observation of gram-positive encapsulated bacilli in gram prepations and/or culture positive of samples taken from lesions. In the cases who were culture-negative and without bacilli in gram-staining, the diagnosis was based on the presence of characteristic clinical presentation with a history of severe scarring formation, swelling, black eschar and positive response to the treatment.. A total of 21 patients with cutaneous palpebral anthrax admitted to the two hospitals between January 2000 and December 2012. Eight patients were male (38.1%) and 13 patients were female (61.9%), and the mean age was 31 ± 21.2 (range 1-82 years). The most common symptoms on admission to the hospital were swelling and redness on the skin. Periorbital lesions were in the right eye in 14 cases and the most common eyelid involvement was seen in upper eyelid with 15 cases. The diagnosis was based on isolation of bacteria in five (23.8%) cases, detection of gram-positive bacilli in direct examination of characteristic lesion material in six (28.5%) cases. Ten (47.7%) cases were diagnosed by the characteristic appearance of the lesion. Malignant pustule was seen in all of our patients and seven cases (33.4%) had malignant edema. In the treatment, penicilin was used for 10 (47.7%) cases, ampicillin-sulbactam for five (23.8%) cases and, ciprofloxacin for three (14.3%) cases. Cicatricial ectropion was observed in 10 (47.7%) patients, lagophthalmos developed in four (19%) patients, and corneal scar in two (9.5%) patients. The distribution of the cases did not differ by the year but showed a density in the months from July to September (62.7%).. Early diagnosis and high dose antibiotic treatment can facilitate the treatment and prevent development of eyelid complications including cicatricial ectropion, corneal scars and palpebral symphysis. Prolonged follow-up is necessary in patients who develop complications and surgical intervention.

Topics: Adolescent; Adult; Aged; Aged, 80 and over; Ampicillin; Anthrax; Anti-Bacterial Agents; Bacillus anthracis; Cefazolin; Child; Child, Preschool; Ciprofloxacin; Eye; Female; Humans; Infant; Male; Middle Aged; Penicillins; Skin Diseases, Bacterial; Sulbactam; Young Adult

The FDA recently issued guidance for the types of infections that should be included in trials to support an indication for antibacterial treatment. The latest FDA guidance recommends assessing response to drug therapy at 48 to 72 hours as the primary endpoint in clinical trials. This study evaluated clinical and economic outcomes among acute bacterial skin and skin structure infections (ABSSSI) patients hospitalized at a 3000-bed healthcare system in New Jersey.. In this retrospective cohort analysis, adult ABSSSI patients hospitalized between July 2010 and December 2011 were stratified based on infection type: cellulitis/erysipelas and major cutaneous abscess, wound infection, and all ABSSSI. Initial antibiotic therapy was assessed by individual agent, regimen, and MRSA coverage. Day 3 response to initial antibiotic therapy was evaluated based on temperature and lesion cessation outcomes; clinical response rates were assessed by initial therapy and pathogen for each cohort. The impact of response on length of stay (LOS), cost of care, and antibiotic treatment duration were also evaluated.. Commonly used antibiotics included vancomycin, cefazolin, piperacillin-tazobactam, and ampicillin-sulbactam; over 40% of patients received empiric therapy with activity against MRSA. Clinical non-response to initial antimicrobial therapy at Day 3 was 39.9%, 30.3%, and 60.7%, for all ABSSSI, cellulitis/abscess, and wound infection patients, respectively. The cost of care among non-responders was over 1.5 times that of responders (p < 0.0001). Non-response to initial therapy was associated with a 3.7 day increase in duration of antibiotic treatment (p < 0.0001).. Results of this study demonstrate that a significant percentage of ABSSSI patients, particularly those with wound infection, were not achieving clinical response at Day 3 of therapy. Failure to respond to drug therapy is associated with substantial increases in LOS, antibiotic treatment duration, and cost of care.. This had the inherent limitations associated with a retrospective chart review; because data was initially collected for clinical rather than research purposes, certain information may have been absent, incomplete, or missed by data abstractors.

Topics: Aged; Ampicillin; Anti-Bacterial Agents; Cefazolin; Female; Hospitalization; Humans; Male; Methicillin-Resistant Staphylococcus aureus; Penicillanic Acid; Piperacillin; Piperacillin, Tazobactam Drug Combination; Retrospective Studies; Skin Diseases, Bacterial; Skin Diseases, Infectious; Sulbactam; Treatment Outcome; Vancomycin

In recent years, carbapenem-resistant Acinetobacter baumannii infections have been responsible for outbreaks in medical facilities. A 35-year-old Japanese woman developed a skin and soft tissue infection due to carbapenem-resistant A. baumannii. The isolate was resistant to antibiotics other than ampicillin-sulbactam and colistin, suggesting drug resistance due to carbapenemase production by OXA-23. We selected a combination therapy consisting of intravenous ampicillin-sulbactam and meropenem. No changes were observed in aspartate aminotransferase, alanine aminotransferase, blood urea nitrogen, or serum creatinine during therapy, and carbapenem-resistant A. baumannii was not detected in wound exudates 3 days after therapy initiation. In our patient's case, combination therapy with ampicillin-sulbactam and meropenem was successful. Thus, combination therapy with ampicillin-sulbactam and meropenem is effective against skin and soft tissue infection due to carbapenem-resistant A. baumannii. Combination therapy with intravenous ampicillin-sulbactam and meropenem may be an option for skin and soft tissue infections due to carbapenem-resistant A. baumannii.

Topics: Acinetobacter baumannii; Acinetobacter Infections; Adult; Ampicillin; Anti-Bacterial Agents; beta-Lactam Resistance; Carbapenems; Drug Therapy, Combination; Female; Humans; Meropenem; Microbial Sensitivity Tests; Skin Diseases, Bacterial; Soft Tissue Infections; Sulbactam; Thienamycins; Treatment Outcome

Topics: Adult; Ampicillin; Drug Therapy, Combination; Humans; Middle Aged; Skin Diseases, Bacterial; Sulbactam; Suppuration

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