AN INTERNATIONAL MULTICENTRE CONTROLLED CLINICAL TRIAL TO EVALUATE 1200MG AND 1800MG RIFAMPICIN DAILY IN THE REDUCTION OF TREATMENT DURATION FOR PULMONARY TUBERCULOSIS FROM 6 MONTHS TO 4 MONTHS (RIFASHORT)

Not Applicable

• Conditions: -A150 Tuberculosis of lung, confirmed by sputum microscopy with or without culture; Tuberculosis of lung, confirmed by sputum microscopy with or without culture; A150

• Registration Number: PER-007-17
• Lead Sponsor: St Georges University of London,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-06-26
• Study Completion: 2021-08-23
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

Patient inclusion criteria
1. Patients with:
a) Newly diagnosed, smear microscopy positive, pulmonary tuberculosis, rifampicin susceptible MTBC confirmed by Xpert MTB/RIF
OR
b) Smear microscopy negative, suspected pulmonary tuberculosis, confirmed by Xpert MTB/RIF as sputum MTBC positive and rifampicin susceptible
2. No more than one week of previous treatment for tuberculosis, for either active TB or treatment of confirmed or presumed latent TB infection.
3. Patients ≥ 18 years old
4. Consent to participation in the trial and to HIV testing
5. Provide informed consent.
6. Patient has a stable home address within easy reach of the treatment facility and likely to remain there for the entire treatment and follow-up period.
7. Women who are pre-menopausal or of a child-bearing age must be using a barrier form of contraception (condoms, diaphragms, cervical caps, or contraceptive sponges), be surgically sterilised or have an intrauterine coil device (IUCD) in place for the duration of the treatment phase, alternatively they should agree to abstain from sexual activity during the treatment phase.

Exclusion Criteria

1. Patients with rifampicin resistance identified by Xpert MTB/RIF or by direct susceptibility testing (late exclusions).
2. Patient is in a moribund phase.
3. Has TB meningitis or extra-pulmonary TB.
4. Is female and known to be pregnant, or breast feeding.
5. Is suffering from a condition likely to lead to uncooperative behaviour such as psychiatric illness or alcoholism.
6. Has a history of seizures
7. Has contraindications to any medications in the study regimens
8. Is HIV positive according to local testing algorithm
9. Has a blood disorder (including grade 4 or above thrombocytopenia)
10. Haemoglobin <7g/dl
11. Has peripheral neuritis
12. Has pre-existing liver disease
13. ALT > 5 times the upper limit of normal (ULN) for that laboratory
14. Raised Bilirubin (grade 4 or above)
15. Has kidney disease
16. Estimated Creatinine clearance of < 30mls/min. Calculated using the Cockcroft Gault Formula: CrCl (mL/min) = N x [140-age (years)] x weight (kg) Serum creatinine (micromol/L) Where N = 1.23 males, 1.04 females
17. Previously diagnosed diabetes mellitus (non-insulin dependent or insulin dependent)
18. HbA1C >48mmol/mol
19. Weight < 35kg
20. Patient is taking any of the excluded medications listed in the Summary of Product Characteristics (SmPC) for any trial drugs
21. Has other pre-existing non-tuberculous disease likely to prejudice the response to, or assessment of, treatment as judged by the Principal Investigator.

Study & Design

• Study Type: Interventional
• Study Design: Not specified