Drug-susceptible and drug-resistant pulmonary tuberculosis Infections and Infestations Respiratory tuberculosis, not confirmed bacteriologically or histologically
Conditions
Interventions
Pragmatic cluster randomised controlled superiority trial with two parallel groups, fixed number of clusters of unequal size and a primary endpoint of adherence to outpatient TB treatment of patients
Sponsors
Curatio International Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged =18 2. All new or previously treated patients with pulmonary TB 3. Assigned to outpatient TB treatment not more than one month prior to enrolment in the study; This restriction (not more than one month treatment) does not refer to patients whose most recent treatment outcome was failure and who were assigned to a new treatment regimen 4. Assigned to outpatient TB treatment at outpatient facility or at home (through DOT) according to the national TB treatment guidelines 5. TB diagnosis established by a direct sputum smear microscopy, culture or Gene Xpert MTB/RIF (bacteriologically confirmed case), OR TB diagnosis established by an X-ray, histological or morphological changes (clinically diagnosed case)
Exclusion criteria
Exclusion criteria: 1. TB outpatient treatment started more than one month prior to enrolment in the study 2. Patients with extra-pulmonary TB 3. Patients with DS-TB with more than two months of hospitalisation or patients with DR-TB with more than 6 months of hospitalisation 4. Patients known at the start of treatment to require the treatment longer than it is recommended by the Georgian TB Management Guidelines for the appropriate type of TB 5. Custody patients 6. Patients involved in other clinical studies related to TB treatment 7. Patients with intention to leave the place within next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Loss to follow-up of patients with DS-TB or DR-TB, defined as the difference between the two intervention arms in the proportion of patients who did not start treatment or whose treatment was interrupted for 2 consecutive months or more. The trial will collect and compare loss to follow-up as follows: 1.1. Loss-to-follow-up for patients with pulmonary DS-TB at 3 months 1.2. Loss-to-follow-up for patients with pulmonary DS-TB at 6 months 1.3. Loss-to-follow-up for patients with pulmonary DR-TB at 3 months 1.4. Loss-to-follow-up for patients with pulmonary DR-TB at 6 months 1.5. Loss-to-follow-up for patients with pulmonary DR-TB at 9 months 1.6. Loss-to-follow-up for patients with pulmonary DR-TB at 12 months 1.7. Loss-to-follow-up for patients with pulmonary DR-TB at 15 months 1.8. Loss-to-follow-up for patients with pulmonary DR-TB at 18 months 1.9. Loss-to-follow-up for patients with pulmonary DR-TB at 21 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.1. Secondary outcome: treatment success rate among patients with DS-TB, defined as per WHO 2014, calculated as the difference in the proportion of patients classed as successfully treated between trial arms annually or bi-annually. 1.2. Adherence to TB treatment among patients with DS-TB and DR-TB, defined as difference between intervention and control arm in the proportion of patients who remained on treatment six months after the treatment was initiated (regardless where the treatment was initiated, outpatient or inpatient). The trial will collect and compare adherence outcomes as follows: 1.2.1. Adherence to DOT for patients with pulmonary DS-TB after 3 months 1.2.2. Adherence to DOT for patients with pulmonary DS-TB at 6 months 1.2.3. Adherence to DOT for patients with pulmonary DR-TB at 6 months 1.2.4. Adherence to DOT for patients with pulmonary DR-TB at 9 months 1.2.5. Adherence to DOT for patients with pulmonary DR-TB at 12 months 1.2.6. Adherence to DOT for patients with pulmonary DR-TB at 15 months 1.2.7. Adherence to DOT for patients with pulmonary DR-TB at 18 months 1.2.8. Adherence to DOT for patients with pulmonary DR-TB at 21 months 1.2.9. Adherence to DOT for patients with pulmonary DR-TB at 24 months The definition of adherence to DOT for patients with pulmonary DS-TB is as follows: 1. From the start of the treatment up to the treatment completion, not more than one missing day per month if patient visits a facility 8-12 –times during a month to fulfil DOT (DOT is performed 2 or 3 days per week. Every other day patient receives drugs at home) 2. From the start of the treatment up to the treatment completion, no single missing day per month if patient visits a facility 4 – times during a month to fulfil DOT (some patients visit | — |
Countries
Georgia
Contacts
Public ContactMaia Uchaneishvili
Outcome results
None listed