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

NCT00914888 Phase 3 WITHDRAWN

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).

Details

Lead sponsor	Wyeth is now a wholly owned subsidiary of Pfizer
Phase	Phase 3
Status	WITHDRAWN
Start date	2011-01
Completion	2014-05

Conditions

• Community Acquired Bacterial Pneumonia
• Complicated Intra-Abdominal Infection

Interventions

• Tigecycline
• Tigecycline
• cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside
• CAP: Ceftriaxone, plus if applicable oral clarithromycin

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 — 2 to 7 weeks for cIAI and 2 to 5 weeks for CAP