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Metronidazole for Pulmonary Tuberculosis (South Korea)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier:
NCT00425113
First received: January 19, 2007
Last updated: May 10, 2013
Last verified: May 2013
Results First Received: February 7, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Tuberculosis
Multi-Drug Resistant Tuberculosis
Interventions: Drug: Metronidazole
Procedure: Blood Draw
Procedure: CT Scan
Procedure: PET Scan

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pulmonary multidrug-resistant tuberculosis subjects were recruited from the National Masan Hospital, Masan, South Korea from 2009-2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metronidazole Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
Placebo No text entered.

Participant Flow:   Overall Study
    Metronidazole     Placebo  
STARTED     17     18  
Exposed to Study Drug     16     17  
COMPLETED     15 [1]   16 [1]
NOT COMPLETED     2     2  
uncontrolled diabetes mellitus                 1                 0  
diagnosis of abdominal TB                 0                 1  
missing study drug more than 14 days                 0                 1  
Withdrawal by Subject                 1                 0  
[1] Included in modified intent-to-treat analysis



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
2 subjects excluded: 1 for uncontrolled diabetes mellitus and 1 for diagnosis of extrapulmonary TB. 2 additional subjects withdrew: 1 self- withdrew and the other was withdrawn for missing >14 days of study drug.

Reporting Groups
  Description
Metronidazole Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Metronidazole     Placebo     Total  
Number of Participants  
[units: participants]
  15     16     31  
Age  
[units: years]
Median ( Inter-Quartile Range )
  36  
  ( 28 to 39 )  
  38  
  ( 31 to 44 )  
  37  
  ( 30 to 43 )  
Gender  
[units: participants]
     
Female     2     4     6  
Male     13     12     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes in TB Lesion Sizes Using High Resolution Computed Tomography (HRCT).   [ Time Frame: 6 months. ]

2.  Secondary:   Time to Sputum Culture Conversion to Negative on Solid Medium   [ Time Frame: 2 months ]


  Serious Adverse Events


  Other Adverse Events


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Major limitation of our study was the small sample size. Planned enrollment was 80 subjects but DSMB recommended closing the study to new enrollment after 35 subjects due to increased peripheral neuropathy in the metronidazole arm.  


Results Point of Contact:  
Name/Title: Ray Chen
Organization: National Institute of Allergy and Infectious Diseases
phone: 301-443-5816
e-mail: ray.chen@nih.gov


Publications:

Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT00425113     History of Changes
Other Study ID Numbers: 999907041, 07-I-N041
Study First Received: January 19, 2007
Results First Received: February 7, 2013
Last Updated: May 10, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Data and Safety Monitoring Board
Korea: Institutional Review Board