Multi-drug resistant tuberculosis (MDR-TB) Infections and Infestations Tuberculosis
Conditions
Interventions
In arm 1 (hospitalisation) each patient will be hospitalized for initial about two months, and hospital inpatient staff will administer daily drugs under supervision. After two months, they will be re
Sponsors
University of Leeds - COMDIS-HSD (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All sputum positive confirmed adult cases of MDR-TB, of both gender, registered at selected treating hospitals, residents of the same district as that of the strengthened MDR TB DOTS Plus clinics
Exclusion criteria
Exclusion criteria: 1. Patients who require hospitalisation for medical reasons other than MDR-TB, before or after registration, as these patients cannot be randomized 2. Patient belongs to a family from which one patient has already been recruited in the trial 3. Is less than twelve years old and 4. Patient does not consent to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of treatment success (cure and treatment completion rate) of MDR-TB treatment for community-based care as compared to hospital-based care | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Intermediary outcomes like sputum and culture conversion will be assessed 2. The feasibility assessment, through economic and qualitative studies, will address both the patients abilities to cope with care requirements (both for hospital-based and community-based options) and the programme?s ability to manage the services including cost and quality of care 3. We will include the indicators - such as treatment adherence and reasons for default. We will investigate patient and provider opinion on these issues, including side effects, influencing adherence and outcomes in the qualitative study. However, the drug regimens have already been decided by the decision of the NTP, and are not a focus of this trial. | — |
Countries
Pakistan
Outcome results
None listed