Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jul 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 21, 2011
CompletedFirst Posted
Study publicly available on registry
April 27, 2011
CompletedStudy Start
First participant enrolled
July 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJanuary 18, 2012
January 1, 2012
11 months
April 21, 2011
January 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effectiveness
Clinical response is classified as cure, improvement, failure, relapse, death.
at the end of therapy (up to 28 days)
Secondary Outcomes (1)
Microbiological outcomes
At the end of therapy (up to 28 days)
Study Arms (1)
Tigecycline
EXPERIMENTALTigecycline 100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 d
Interventions
100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Siriraj Hospital
Bangkok, Bangkok, 10700, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Visanu Thamlikitkul, MD
Siriraj Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Faculty of Medicine Siriraj Hospital
Study Record Dates
First Submitted
April 21, 2011
First Posted
April 27, 2011
Study Start
July 1, 2011
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
January 18, 2012
Record last verified: 2012-01