Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
|ClinicalTrials.gov Identifier: NCT01342731|
Recruitment Status : Unknown
Verified January 2012 by Visanu Thamlikitkul, Mahidol University.
Recruitment status was: Recruiting
First Posted : April 27, 2011
Last Update Posted : January 18, 2012
|Condition or disease||Intervention/treatment||Phase|
|Antibiotic Resistant Infection||Drug: Tigecycline||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||June 2012|
|Estimated Study Completion Date :||December 2012|
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
- Effectiveness [ Time Frame: at the end of therapy (up to 28 days) ]Clinical response is classified as cure, improvement, failure, relapse, death.
- Microbiological outcomes [ Time Frame: At the end of therapy (up to 28 days) ]Microbiological outcome is classified as eradication, persistence, colonization, and superinfection.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01342731
|Contact: Visanu Thamlikitkul, MDemail@example.com|
|Bangkok, Thailand, 10700|
|Contact: Visanu Thamlikitkul, MD 662-412-5994 firstname.lastname@example.org|
|Sub-Investigator: Peerawong Weerarak, MD|
|Principal Investigator:||Visanu Thamlikitkul, MD||Faculty of Medicine Siriraj Hospital|