Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
Information source: Mahidol University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Antibiotic Resistant Infection
Intervention: Tigecycline (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Mahidol University Official(s) and/or principal investigator(s):
Visanu Thamlikitkul, MD, Principal Investigator, Affiliation: Faculty of Medicine Siriraj Hospital
Overall contact:
Visanu Thamlikitkul, MD, Phone: 662-412-5994, Email: sivth@mahidol.ac.th
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.
Clinical Details
Official title: Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Effectiveness
Secondary outcome: Microbiological outcomes
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Visanu Thamlikitkul, MD, Phone: 662-412-5994, Email: sivth@mahidol.ac.th
Siriraj Hospital, Bangkok 10700, Thailand; Recruiting
Visanu Thamlikitkul, MD, Phone: 662-412-5994, Email: sivth@mahidol.ac.th
Peerawong Weerarak, MD, Sub-Investigator
Additional Information
Starting date: July 2011
Last updated: January 16, 2012
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