Overview

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

Status:
Withdrawn

Trial end date:
2014-05-01

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Treatments:

Amoxicillin-Potassium Clavulanate Combination
Ceftriaxone
Clarithromycin
Metronidazole
Minocycline
Tigecycline

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).