Rapid urine-based Screening for Tuberculosis to reduce AIDS-related Mortality in hospitalized Patients in Africa (STAMP) trial
Completed
- Conditions
- HIV-associated tuberculosisInfections and Infestations
- Registration Number
- ISRCTN71603869
- Lead Sponsor
- ondon School of Hygiene & Tropical Medicine
- Brief Summary
2016 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/27659507 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30032978
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 2600
Inclusion Criteria
1. Requires acute admission to a hospital medical ward
2. Have confirmed HIV-infection
3. Willing and able to provide informed consent
Exclusion Criteria
1. Aged <18 years
2. Has been admitted to a medical ward for longer than 48 hours
3. Has received treatment for TB within the preceding 12 months, or has received isoniazid preventative therapy (IPT) within the last 6 months
4. Residence does not lie within a pre-defined geographic area or plans to leave this area during the period of trial follow-up
5. Unable or unwilling to provide informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Risk of all-cause mortality at 56 days after randomization from any cause, compared between arms.
- Secondary Outcome Measures
Name Time Method 1. Time to all-cause mortality<br>2. Proportions of patients with:<br>2.1. Microbiologically confirmed diagnosis of TB<br>2.2. Clinically diagnosed TB disease<br>3. Time from randomisation to:<br>3.1. TB diagnosis<br>3.2. Start of TB treatment in days<br>4. Proportion of patients receiving:<br>4.1. Antibacterial treatment<br>4.2. In ART naïve patients, proportion starting ART and time to ART initiation in days<br>5.1. Duration of hospital stay in days<br>5.2. Cumulative incidence of hospital readmission (c) cumulative incidence of loss to follow-up<br><br>All measured at 56 days after randomization