Study Evaluating Tigecycline Versus Ceftriaxone in Complicated Intra Abdominal Infections & Community Acquired Pneumonia
Information source: Wyeth
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Community Acquired Pneumonia; Intra-abdominal Infection
Intervention: Tigecycline (Drug); cIAI: Ceftriaxone plus metronidazole plus, if applicable, aminoglycoside. CAP: Ceftriaxone plus, if applicable, oral clarithromycin (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com
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).
Clinical Details
Official title: Multicenter, Randomized, and Double-blind Study to Evaluate the Safety of Tigecycline Versus a Ceftriaxone Regimen in the Treatment of Complicated Intra-abdominal Infections and Community-acquired Pneumonia in Subjects of 8-17 Years
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: The tolerability of tigecycline (safety) will be monitored by measuring vital signs, adverse event, laboratory values, ECG, and clinical signs and symptoms of the infection.
Secondary outcome: Tigecycline vs ceftriaxone clinical efficacy based on subject outcome: last day of intravenous therapy, test of cure, follow-up. Infection clearance: subject & pathogen response. Pharmacokinetic/pharmacodynamic. Susceptibility for a range of pathogens
Eligibility
Minimum age: 8 Years.
Maximum age: 17 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria (non exhaustive list):
1. 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.
2. Have a diagnosis of a serious infection (cIAI or CAP - as applicable) requiring
hospitalization and administration of IV antibiotic therapy.
3. Criteria related indication (cIAI or CAP - as applicable) eg sign of systemic
infection, signs and symptom.
Exclusion Criteria (non exhaustive list):
1. 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).
Locations and Contacts
Trial Manager, Email: clintrialparticipation@wyeth.com
Muscat 35, Oman; Recruiting
trial manager, Email: clintrialparticipation@wyeth.com
Doha 3050, Qatar; Recruiting
trial manager, Email: clintrialparticipation@wyeth.com
Jeddah 21423, Saudi Arabia; Recruiting
trial manager, Email: clintrialparticipation@wyeth.com
Riyadh 11426, Saudi Arabia; Recruiting
trial manager, Email: clintrialparticipation@wyeth.com
Richmond, Virginia 23298, United States; Recruiting
Additional Information
Starting date: June 2009
Ending date: June 2012
Last updated: August 21, 2009
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