Status:
COMPLETED
Latency in Pulmonary Tuberculosis
Lead Sponsor:
Tuberculosis Research Centre, India
Collaborating Sponsors:
National Institutes of Health (NIH)
Conditions:
Pulmonary Tuberculosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The immune responses in latent tuberculosis are poorly understood. While it is difficult to define the onset of latency during natural infection, patients undergoing treatment for tuberculosis are dri...
Detailed Description
Although Mycobacterium tuberculosis (Mtb) infects approximately 2 billion people worldwide, 90% of Mtb infected individuals are able to resist overt disease (active tuberculosis) development and manif...
Eligibility Criteria
Inclusion
- Age 18 years and above
- Residing in or around Chennai or Madurai
- No anti-TB treatment in the past or should have had less than one month of treatment (but less than one week in the preceding one month before enrollment in the study)
- At least two sputum smears should be positive for tubercle bacilli by fluorescent microscopy
- Express willingness to attend the treatment centre for supervised treatment
- Express willingness for home visits by the staff of the centre
- Express willingness to give written informed consent
Exclusion
- Body weight less than 30 kg
- Hepatic or renal disease as evidenced by clinical or biochemical abnormalities
- Diabetes mellitus
- A history of seizure or loss of consciousness
- Psychiatric illness
- An abnormal electrocardiogram or anti-arrhythmic medication
- Those in a moribund state
- Sero-positive for HIV antibodies
- Pregnancy or lactation
- Visual disorders other than refractory error
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT01154959
Start Date
February 1 2010
End Date
July 1 2016
Last Update
April 19 2021
Active Locations (1)
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1
Tuberculosis Research Centre
Chennai, Tamil Nadu, India, 600031