Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
Recruitment status was Recruiting
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii|
- Effectiveness [ Time Frame: at the end of therapy (up to 28 days) ] [ Designated as safety issue: Yes ]Clinical response is classified as cure, improvement, failure, relapse, death.
- Microbiological outcomes [ Time Frame: At the end of therapy (up to 28 days) ] [ Designated as safety issue: Yes ]Microbiological outcome is classified as eradication, persistence, colonization, and superinfection.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||June 2012 (Final data collection date for primary outcome measure)|
Tigecycline 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 d
100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
Other Name: Tygacil
To determine effectiveness and safety of tigecycline for therapy of hospitalized patients with infections due to MDR A. baumannii.
Study Design Open label phase IV study
It is estimated that a favorable response rate in patients infected with MDR A. baumannii who received tigecycline is 60% +/- 20% with 5% type I error. Therefore the estimated sample size is 24 patients. This study will enroll 30 patients in order to compensate for some patients who may not be available to have a complete follow up.
All eligible patients will be identified through the pharmacy database and microbiology database on daily basis. The investigator will obtain written consent from each potential patient. Consent must be documented by the patient's dated signature on a consent form along with the dated signature of the person conducting the consent discussion. If the patient is in the state that can not make decision, the written consent of a parent, legal guardian or legal representative must be obtained. Intervention: The eligible patients will receive 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
Evaluation/Follow - Up:
Clinical outcomes on effectiveness and safety will be evaluated on daily basis up to 28 days. Follow-up culture of clinical specimen from the site of infection will be obtained on day 3 and at the end of tigecycline therapy. Clinical response is classified as cure, improvement, failure, relapse, death. Microbiological outcome is assessed at the end of treatment and classified as eradication, persistence, colonization, and superinfection. Adverse events, overall 28-day mortality and infection-related mortality will be determined. Length of stay will also be determined.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01342731
|Contact: Visanu Thamlikitkul, MDfirstname.lastname@example.org|
|Bangkok, Thailand, 10700|
|Contact: Visanu Thamlikitkul, MD 662-412-5994 email@example.com|
|Sub-Investigator: Peerawong Weerarak, MD|
|Principal Investigator:||Visanu Thamlikitkul, MD||Faculty of Medicine Siriraj Hospital|