Status:
COMPLETED
Brief Bactericidal Activity of Anti-Tuberculosis Drugs
Lead Sponsor:
Centers for Disease Control and Prevention
Collaborating Sponsors:
Kenya Medical Research Institute
Conditions:
Tuberculosis
Drug-resistant Tuberculosis
Eligibility:
All Genders
8-99 years
Phase:
PHASE1
Brief Summary
The investigators will determine the bactericidal activity of high-dose isoniazid against M. tuberculosis isolates that are (1) susceptible to isoniazid at 2.0 mcg/ml but resistant at 0.1 and 0.4 mcg/...
Eligibility Criteria
Inclusion
- Written informed consent
- INH resistance by approved molecular genetic test
- Phenotypic drug susceptibility test results match one of the required patterns
- Sputum microscopy positive for acid fast bacilli
Exclusion
- Ineligible for MDR TB treatment according to national guidelines
- HIV infection with CD4 count less than 50
- Pregnancy
- Incarceration
- Too sick to participate (Karnofsky score \<60, arterial pO2\<90, respiratory rate repeatedly \>25/min, clinician's judgment)
- Hepatic enzymes \>3x normal
- Estimated glomerular filtration rate \<60 mL/min/1.73 m2
- Unable to provide adequate sputum specimen
Key Trial Info
Start Date :
November 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2020
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT02236078
Start Date
November 1 2015
End Date
September 30 2020
Last Update
October 19 2020
Active Locations (1)
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1
National Institute for Research on Tuberculosis
Chennai, Tamil Nadu, India