Clinical trial NCT01602874: Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
Official title: Multicenter, Randomized, And Double-Blind Study To Evaluate The Safety Of Tigecycline Versus A Ceftriaxone Regimen In The Treatment Of Complicated Intra-Abdominal Infections And Community-Acquired Pneumonia In Subjects Of 8-17 Years
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Community Acquired Bacterial Pneumonia
Complicated Intra-Abdominal Infection
Keywords: children
pediatry
pneumonia
intra-abdominal
infection
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2012-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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).

Primary outcomes:
measure: 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
timeFrame: 2 to 7 weeks for cIAI and 2 to 5 weeks for CAP
Secondary outcomes:
measure: Clinical response at the IV last day of therapy (LDOT) for co-primary populations: the CE and c-mITT populations
timeFrame: 5 days to 4 weeks for cIAI and 5 days to 2 weeks for CAP
measure: Clinical response at follow up (FUP) visits for co-primary populations: the CE and c-mITT populations
timeFrame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
measure: Microbiological response at the subject and the pathogen level
timeFrame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
measure: Response rate by pathogen and minimum inhibitory concentration (MIC) value
timeFrame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
measure: Response rates for polymicrobial/monomicrobial infections, and susceptibility evaluations
timeFrame: 5 to 9 weeks for cIAI and 5 to 7 weeks for CAP
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: