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Withdrawn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?
No
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).