Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
Primary Purpose
Antibiotic Resistant Infection
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Tigecycline
Sponsored by
About this trial
This is an interventional treatment trial for Antibiotic Resistant Infection focused on measuring Tigecycline, A.baumannii, Drug safety
Eligibility Criteria
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
Sites / Locations
- Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tigecycline
Arm Description
Tigecycline 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 d
Outcomes
Primary Outcome Measures
Effectiveness
Clinical response is classified as cure, improvement, failure, relapse, death.
Secondary Outcome Measures
Microbiological outcomes
Microbiological outcome is classified as eradication, persistence, colonization, and superinfection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01342731
Brief Title
Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
Official Title
Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Antibiotic Resistant Infection
Keywords
Tigecycline, A.baumannii, Drug safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tigecycline
Arm Type
Experimental
Arm Description
Tigecycline 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 d
Intervention Type
Drug
Intervention Name(s)
Tigecycline
Other Intervention Name(s)
Tygacil
Intervention Description
100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
Primary Outcome Measure Information:
Title
Effectiveness
Description
Clinical response is classified as cure, improvement, failure, relapse, death.
Time Frame
at the end of therapy (up to 28 days)
Secondary Outcome Measure Information:
Title
Microbiological outcomes
Description
Microbiological outcome is classified as eradication, persistence, colonization, and superinfection.
Time Frame
At the end of therapy (up to 28 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Visanu Thamlikitkul, MD
Phone
662-412-5994
Email
sivth@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Visanu Thamlikitkul, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Siriraj Hospital
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Visanu Thamlikitkul, MD
Phone
662-412-5994
Email
sivth@mahidol.ac.th
First Name & Middle Initial & Last Name & Degree
Peerawong Weerarak, MD
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
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