NCT01602874WithdrawnPhase 3
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Withdrawn
- Sponsor
- Pfizer
- Primary Endpoint
- 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
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
A. Tigecycline
Experimental
Intervention: Tigecycline (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 2 to 7 weeks for cIAI and 2 to 5 weeks for CAP
Secondary Outcomes
- 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)
Investigators
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