Trial intelligence / Profile preview

Tigecycline vs Ceftriaxone in Pediatric cIAI and CAP

NCT00914888Phase 3

Key facts

Status: Withdrawn
Start: Jan 2011
Primary completion: May 2014
Sponsor: Pfizer
Modality: Orthosteric Ligands

Drugs: tigecycline
Conditions: Intra-abdominal infection (IAI)community acquired pneumonia (CAP)

Overview

Phase 3, randomised, double-blind trial of tigecycline in Intra-abdominal infection (IAI) and community acquired pneumonia (CAP) (2 arms), sponsored by Pfizer. Primary endpoint: Clinical efficacy response (cure, failure, or indeterminate). Planned start Jan 2011; status: withdrawn.

Design

2 arms

Study design: RandomizedDouble-blind

Tigecycline
Tigecycline IV
Ceftriaxone
Ceftriaxone IV (+/- Metronidazole/Clarithromycin)

Who it enrols

Pediatric patients (8-17 years) with cIAI or CAP requiring hospitalization and IV antibiotics.

Endpoints

Primary

Clinical efficacy response (cure, failure, or indeterminate)2 to 5 weeks

Secondary

Clinical response at the IV last day of therapy (LDOT)5 days to 2 weeks
Clinical response at follow up (FUP) visits5 to 7 weeks
Microbiological response at the subject and the pathogen level5 to 7 weeks

Beyond the preview

Go deeper on NCT00914888.

Full results, competitive context and analysis are in the Gosset platform.

Full results & analysis

Available in the Gosset platform where reported.

Competitive context

Available in the Gosset platform where reported.

Bring the full picture into focus.

See how Gosset can support your research on NCT00914888.