Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia

Phase 3

Withdrawn

• Conditions: Community Acquired Bacterial Pneumonia; Complicated Intra-Abdominal Infection
• Interventions: Drug: Tigecycline

• Registration Number: NCT01602874
• Lead Sponsor: Pfizer

Brief Summary

The main purpose of this study is to compare the safety of tigecycline versus a ceftriaxone regimen in pediatric subjects (aged 8 to 17 years) with complicated intra-abdominal infections (cIAI) and community acquired pneumonia (CAP).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-05-17
• Study First Submitted QC: 2012-05-17
• Study First Posted: 2012-05-21
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-22
• Primary Completion: 2014-05
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Male or female subjects 8 to 17 years old. Children with bone maturation less than 8 years old should be enrolled with caution due to potential risk of tooth discoloration.
• Have a diagnosis of a serious infection (complicated intra-abdominal infections [cIAI] or community acquired pneumonia [CAP] as applicable) requiring hospitalization and administration of IV antibiotic therapy.
• Criteria related indication (cIAI or CAP - as applicable), e.g., sign of systemic infection, signs and symptom.

Exclusion Criteria

• Subject with any concomitant illness/condition that, in the investigator's judgment, will substantially increase the risk associated with the subject's participation in and/or completion of the study, or could preclude the evaluation of the subject's response (e.g., life expectancy <30 days).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A. Tigecycline	Tigecycline	-

Primary Outcome Measures

Name	Time	Method
Clinical efficacy response (cure, failure, or indeterminate) at the test of cure (TOC) visit for 2 co-primary populations: the clinically evaluable (CE) and clinical modified Intent-to-Treat (c-mITT) populations	2 to 7 weeks for cIAI and 2 to 5 weeks for CAP

Secondary Outcome Measures

Name	Time	Method
Clinical response at the IV last day of therapy (LDOT) for co-primary populations: the CE and c-mITT populations	5 days to 4 weeks for cIAI and 5 days to 2 weeks for CAP
Clinical response at follow up (FUP) visits for co-primary populations: the CE and c-mITT populations	5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Microbiological response at the subject and the pathogen level	5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Response rate by pathogen and minimum inhibitory concentration (MIC) value	5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations	5 to 9 weeks for cIAI and 5 to 7 weeks for CAP