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

Wyeth

Status and phase

Withdrawn

Phase 3

Conditions

Community Acquired Bacterial Pneumonia

Complicated Intra-Abdominal Infection

Treatments

Drug: CAP: Ceftriaxone, plus if applicable oral clarithromycin

Drug: cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside

Drug: Tigecycline

Study type

Interventional

Funder types

Industry

Identifiers

NCT00914888

3074K4-3340

B1811003

Details and patient eligibility

About

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).

Sex

All

Ages

8 to 17 years old

Volunteers

No Healthy Volunteers

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).