Hospital versus community management during the intensive phase of the tuberculosis (TB) re-treatment regime
Not Applicable
Completed
- Conditions
- Community management of patients requiring injectable therapy as part of the TB re-treatment regimenTuberculosisInfections and Infestations
- Registration Number
- ISRCTN05815615
- Lead Sponsor
- iverpool School of Tropical Medicine (UK)
- Brief Summary
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31676719 (added 06/11/2019)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 204
Inclusion Criteria
1. Adults = 16 years of age starting TB re-treatment regimen
2. Patients who are able to give informed consent
3. Patients who are able to identify a suitable treatment supporter
Exclusion Criteria
1. Patients identified as having Multi-drug-resistant tuberculosis (MDR-TB) on GXP or drug sensitivity testing using culture (these patients will be referred to the NTP MDR programme)
2. Pregnant women
3. Patients not planning to stay in Blantyre/Lilongwe for the 2-month duration of the intervention
4. Patients unable to give informed consent
5. Patients unable to identify a suitable treatment supporter
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patient still alive and on TB treatment at the end of the two-month intervention period
- Secondary Outcome Measures
Name Time Method <br> 1. 2-month culture conversion in those culture positive at baseline<br> 2. 8-month programmatic TB outcome<br> 3. Serious adverse events during the intensive phase of treatment<br> 4. Karnofsky score 1, 3, 5, and 7 weeks post randomisation<br> 5. Mental health status at 2 months using a Chichewa validated self-reporting questionnaire (SRQ)<br>