Study Evaluating Tigecycline Versus Clindamycin on Complicated Skin and Skin Structure Infections Including Those Due to Methicillin-resistant Staphylococcus Aureus (MRSA)
Information source: Wyeth
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Skin Diseases; Infectious
Intervention: Tigecycline (Drug); Clindamycin (or Vancomycin if needed) (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 and efficacy of tigecycline versus
clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17
years) with complicated skin and skin structure infections (cSSSI), including those caused
by methicillin-resistant Staphylococcus aureus (MRSA).
Clinical Details
Official title: Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Tigecycline vs Clindamycin for the Treatment of Complicated Skin and Skin Structure Infections, Including Those Due to MRSA, in Pediatric Subject 8-17 Years
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
Primary outcome: Tigecycline vs comparators clinical efficacy based on subject outcome: last day of intravenous therapy, test of cure, follow-up. The tolerability (safety) monitored: vital signs, adverse event, lab values, ECG, clinical signs/symptoms of the infection.
Secondary outcome: 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):
- 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 requiring hospitalization and administration
of IV antibiotic therapy.
- cSSSI criteria related to sign of systemic infection, signs and symptoms.
Exclusion Criteria (non exhaustive list):
- 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
Seoul 138-736, Korea, Republic of; 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: September 25, 2009
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