Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Mahidol University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Visanu Thamlikitkul, Mahidol University
ClinicalTrials.gov Identifier:
NCT01342731
First received: April 21, 2011
Last updated: January 16, 2012
Last verified: January 2012
  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

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01342731

Contacts
Contact: Visanu Thamlikitkul, MD 662-412-5994 sivth@mahidol.ac.th

Locations
Thailand
Siriraj Hospital Recruiting
Bangkok, Thailand, 10700
Contact: Visanu Thamlikitkul, MD    662-412-5994    sivth@mahidol.ac.th   
Sub-Investigator: Peerawong Weerarak, MD         
Sponsors and Collaborators
Mahidol University
Investigators
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 August 28, 2014