Status:
WITHDRAWN
Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia
Lead Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Community Acquired Bacterial Pneumonia
Complicated Intra-Abdominal Infection
Eligibility:
All Genders
8-17 years
Phase:
PHASE3
Brief 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 co...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00914888
Start Date
January 1 2011
End Date
May 1 2014
Last Update
June 7 2012
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