Effect of food rations to prevent TB in household contacts of patients with TB
Not Applicable
Completed
- Conditions
- Health Condition 1: A15-A19- Tuberculosis
- Registration Number
- CTRI/2019/08/020490
- Lead Sponsor
- Dr Anurag Bhargava
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2800
Inclusion Criteria
Patients who are microbiologically positive pulmonary tuberculosis who have household contacts will be the index cases. Household contact is defined as a person of any age living in the same house as the index patient for one or more nights or for frequent or extended periods during the day with the index case for at least 3 months prior to the diagnosis.
Exclusion Criteria
Main exclusion criteria for household contacts: Current smear or CB-NAAT or LPA or culture-confirmed or clinically diagnosed pulmonary or extra-pulmonary TB or currently receiving anti-TB treatment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method TB incidence in household contacts of patients with microbiologically confirmed pulmonary tuberculosisTimepoint: Any case of active TB diagnosed beyond 2 months after diagnosis of the index case up to follow-up period of 24 months after completion of therapy of index case
- Secondary Outcome Measures
Name Time Method In all patients: treatment success rate, relapse, mortality during treatment and F/U and change in anthropometry, performance status. <br/ ><br>In all contacts: change in anthropometric indices, select morbidities and mortality <br/ ><br>In a sub-sample of patients and contacts: Calories and protein intakes, body composition, grip strength <br/ ><br>Immune function assessed by CD4, CD8 counts and Interferon-gamma release assays in undernourished patients and contacts <br/ ><br>Timepoint: Baseline and end of treatment