Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
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Purpose
30 adult hospitalized patients who have infections due to MDR Acinetobacter baumannii will be enrolled. 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. 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Antibiotic Resistant Infection |
Drug: Tigecycline |
Phase 4 |
| Study Type: | Interventional |
| 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.
| Estimated Enrollment: | 30 |
| 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) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tigecycline
Tigecycline 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 d
|
Drug: Tigecycline
100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
Other Name: Tygacil
|
Detailed Description:
Objectives:
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
Sample Size:
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.
Study Procedures:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Hospitalized male or female aged 18 years or older
- Has documented infection due to A. baumannii resistant to cephalosporins, beta-lactams/ beta-lactamase inhibitors, aminoglycosides, fluoroquinolones and carbapenems
- Willing to join the study by signing a written informed consent form
Exclusion Criteria:
- Pregnant or lactating woman
- Has contraindication for receiving tigecycline such as allergy to tetracycline
- Has received colistin for more than 24 hours
- Unable to receive tigecycline monotherapy
Contacts and Locations| Contact: Visanu Thamlikitkul, MD | 662-412-5994 | sivth@mahidol.ac.th |
| Thailand | |
| Siriraj Hospital | Recruiting |
| Bangkok, Thailand, 10700 | |
| Contact: Visanu Thamlikitkul, MD 662-412-5994 sivth@mahidol.ac.th | |
| Sub-Investigator: Peerawong Weerarak, MD | |
| Principal Investigator: | Visanu Thamlikitkul, MD | Faculty of Medicine Siriraj Hospital |
More Information
No publications provided
| Responsible Party: | Visanu Thamlikitkul, Faculty of Medicine Siriraj Hospital, Mahidol University |
| ClinicalTrials.gov Identifier: | NCT01342731 History of Changes |
| Other Study ID Numbers: | CEU 003-11 |
| Study First Received: | April 21, 2011 |
| Last Updated: | January 16, 2012 |
| Health Authority: | Thailand: Ethical Committee |
Keywords provided by Mahidol University:
|
Tigecycline A.baumannii Drug safety |
Additional relevant MeSH terms:
|
Tigecycline Minocycline Anti-Bacterial Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013