Phase 4
Completed N=463
A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Source: ClinicalTrials.gov NCT01721408 ↗Enrolled (actual)
463
Serious AEs
10.3%
Results posted
Apr 2018
Primary outcomePrimary: Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population — 89.9; 96.6; 10.1; 3.4 percentage of participants — p=0.0008
◆ Published Evidence
Emerging
12citations · ~2 / year
A multicenter, double-blind, randomized, comparison study of the efficacy and safety of tigecycline to imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects in China.
Summary
This is a comparative study of the efficacy and safety of tigecycline to imipenem/cilastatin in hospitalized patients with a complicated intra-abdominal infection.
Linked Publications
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A multicenter, double-blind, randomized, comparison study of the efficacy and safety of tigecycline to imipenem/cilastatin to treat complicated intra-abdominal infections in hospitalized subjects in China.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Clinical Response at the Test-of-Cure (TOC) Assessment Within the Clinically Evaluable (CE) Population |
89.9; 96.6; 10.1; 3.4 | 0.0008 sig |
| PRIMARY Clinical Response at the TOC Assessment Within the Modified Intent-to-Treat (mITT) Population |
82.8; 88.7; 10.3; 3.5; 6.9; 7.8 | 0.0040 sig |
| SECONDARY Clinical Response at the TOC Assessment Within the Microbiologically Evaluable (ME) Population |
88.0; 95.3; 12.0; 4.7 | 0.0277 sig |
| SECONDARY Microbiological Response at the Subject Level in the ME Population at the TOC Assessment |
88.0; 95.3; 2.7; 0.0; 97.3; 100.0 | 0.0277 sig |
Eligibility Criteria
Inclusion Criteria
- Hospitalized male or female subjects, at least 18 year of age.
- Complicated intra-abdominal infection is present at most under two weeks duration.
- Minimal clinical criteria at the time of intra-abdominal infection diagnosis or highly suspected intra-abdominal infection.
Exclusion Criteria
- Anticipated length of antibiotic therapy less than 5 days or the likelihood that the subject will not complete the course of treatment.
- Intra-abdominal infection known to be caused by 1 or more bacterial pathogens not susceptible to both of the study drugs.
- Had accepted non-study antibiotics more than 24 hr within 72 hrs before enrollment except for subjects declared prior failures.
Data sourced from ClinicalTrials.gov (NCT01721408) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.