Dataset Information

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.

ABSTRACT:

Background

Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.

Methods

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).

Results

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.

Conclusions

Tigecycline was generally safe and effective in the treatment of cSSSIs.

Trial registration

ClinicalTrials.gov NCT00368537.

SUBMITTER: Matthews P

PROVIDER: S-EPMC3560230 | biostudies-literature | 2012 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.

Matthews Peter P Alpert Marc M Rahav Galia G Rill Denise D Zito Edward E Gardiner David D Pedersen Ron R Babinchak Timothy T McGovern Paul C PC

BMC infectious diseases 20121112

<h4>Background</h4>Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality.<h4>Methods</h4>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 inve ...[more]

PMID: 23145952

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Project description:ObjectivesThe primary aim of the RELIEF study was to evaluate the efficacy and safety of two sequential intravenous (iv)/oral regimens: moxifloxacin iv/oral versus piperacillin/tazobactam (TZP) iv followed by oral amoxicillin/clavulanate (AMC).Patients and methodsThe study had a prospective, randomized, double-dummy, double-blind, multicentre design. Patients ≥18 years were prospectively stratified according to complicated skin and skin structure infection (cSSSI) subtype/diagnosis (major abscess, diabetic foot infection, wound infection or infected ischaemic ulcer), surgical intervention and severity of illness. Diagnoses and disease severity were based on predetermined criteria, documented by repeated photographs, and confirmed by an independent data review committee. Patients were randomized to receive either 400 mg of moxifloxacin iv once daily followed by 400 mg of moxifloxacin orally once daily or 4.0/0.5 g of TZP iv thrice daily followed by 875/125 mg of AMC orally twice daily for 7-21 days. The primary efficacy variable was clinical response at test of cure (TOC) for the per-protocol (PP) population. Clinical efficacy was assessed by the data review committee based on repeated photographs and case descriptions. Clinical trials registry number: NCT 00402727.ResultsA total of 813 patients were randomized. Clinical success rates at TOC were similar for moxifloxacin and TZP-AMC in the PP [320/361 (88.6%) versus 275/307 (89.6%), respectively; P = 0.758] and intent-to-treat (ITT) [350/426 (82.2%) versus 305/377 (80.9%), respectively; P = 0.632] populations. Thus, moxifloxacin was non-inferior to TZP-AMC. Bacteriological success rates were high in both treatment arms [moxifloxacin: 432/497 (86.9%) versus TZP-AMC: 370/429 (86.2%), microbiologically valid (MBV) population]. Moxifloxacin was non-inferior to TZP-AMC at TOC in both the MBV and the ITT populations. Both treatments were well tolerated.ConclusionsOnce-daily iv/oral moxifloxacin monotherapy was clinically and bacteriologically non-inferior to iv TZP thrice daily followed by oral AMC twice daily in patients with cSSSIs.

Project description:ObjectiveTo compare the effectiveness of amoxicillin-clavulanate versus amoxicillin for adults diagnosed with acute sinusitis (AS). A secondary objective compared antibiotic effectiveness in patients meeting risk criteria for treatment failure.MethodsA retrospective cohort study of adults diagnosed with AS prescribed amoxicillin ± clavulanate within Veterans Affairs emergency departments from 2012-2019 was conducted. The primary outcome was sinusitis-related return visits for amoxicillin versus amoxicillin-clavulanate. Secondary outcomes included 30-day infectious complications, gastrointestinal-related adverse events (AEs), and hospitalizations. Propensity-score matching and logistic regression models adjusted for potential confounders.ResultsA total of 89,627 AS patient visits were identified: 18,576 prescribed amoxicillin and 71,051 amoxicillin-clavulanate. Most patients were male (75,604; 84.4%) and afebrile (80,624; 91.7%). The propensity score-matched cohort comprised 17,929 amoxicillin and 42,294 amoxicillin-clavulanate patient visits. There was no difference in sinusitis-related return visits between amoxicillin (4.9%) and amoxicillin-clavulanate (5.1%) (adjusted odds ratio [OR], 0.96; 95% confidence interval [CI], 0.88, 1.04; P = 0.317). Infectious complications (amoxicillin [0.3%] vs amoxicillin-clavulanate [0.4%]); (adjusted OR, 0.78; 95% CI, 0.57, 1.07; P = 0.124) and hospitalization (amoxicillin [2.0%] vs amoxicillin-clavulanate [2.4%]); (adjusted OR, 0.92; 95% CI, 0.81, 1.04; P = 0.173) were not different. Gastrointestinal-related AEs were lower with amoxicillin (0.5%) relative to amoxicillin-clavulanate (0.7%); (adjusted OR, 0.67; 95% CI, 0.53, 0.86; P = 0.002). Comorbidity was the only guideline-recommended risk factor that was a significant predictor of infectious complications with respect to treatment (amoxicillin vs amoxicillin-clavulanate, OR, 0.63; 95% CI, 0.40 to 0.94; P = 0.022).ConclusionAmoxicillin demonstrated similar efficacy to amoxicillin-clavulanate for AS with fewer gastrointestinal-related AEs. Amoxicillin is a viable option in adults with AS meeting criteria for antibiotic therapy.

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Dataset Information

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.

Background

Methods

Results

Conclusions

Trial registration

Publications

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.

Similar Datasets

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