Phase 4
N=463
A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection
Intra-abdominal Infection
Bottom Line
View on ClinicalTrials.gov: NCT01721408 ↗Enrolled (actual)
463
Serious AEs
10.3%
Results posted
Apr 2018
Primary outcome: Primary: 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
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Tigecycline (Drug); Imipenem/cilastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Oct 2015
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 |
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.
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). 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.