UnknownPhase 2

Rifampicin at High Dose for Difficult-to-Treat Tuberculosis

Netherlands, Paraguay, Portugal130 participantsStarted 2021-04-01

Plain-language summary

The purpose of this study is to assess the safety of rifampicin given at a dose three times as the standard one, in persons with tuberculosis that belong to groups that have not been widely included in previous trials.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Subjects with confirmed or probable pulmonary or extra pulmonary DS-TB.
✓. Informed consent provided.
✓. Positive smear, positive Xpert® MTB/RIF test, positive M. tuberculosis culture (confirmed cases) OR histological study compatible with necrotizing granulomas OR a liquid biochemistry (pleural, pericardial, ascites or cerebrospinal fluid) suggestive of TB together with clinical symptoms resembling TB disease in the absence of any other possible cause (probable cases).
✓. Female participants of childbearing age must have a negative pregnancy test at baseline.
✓. Age ≥ 60 years old. OR
✓. Age ≥ 18 years AND one of the following
✓. Body mass index ≤ 18.5
✓. Human Immunodeficiency Virus (HIV) infection.

Exclusion criteria

✕. Rifampicin resistance confirmation.
✕. Barthel index \<40 for subjects older than 60 years old.
✕. Signs of significant liver disease:
✕. Subjects with known allergy or sensitivity to rifampicin, or any of the other components of DS-TB treatment.
✕. Treatment with any of the following: rifampicin, isoniazid, pyrazinamide, ethambutol, levofloxacin, or moxifloxacin within the last month for at least 14 days or current TB treatment for more than 7 days.
✕. The subject is enrolled in any other investigational trial that includes a drug intervention.
✕. Subjects with solid organ transplantation or bone marrow transplantation.
✕. Subjects with an active onco-hematological neoplasm requiring chemotherapy or immune therapy.

What they're measuring

Safety of rifampicin at 35mg/kg/day

Timeframe: During the first 8 weeks after treatment start

Trial details

NCT IDNCT04768231

SponsorHospital Universitari Vall d'Hebron Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-12-31

Contact for this trial

Adrián Sánchez-Montalvá, PhD

+34 934893000 adrian.sanchez.montalva@gmail.com

View on ClinicalTrials.gov More Tuberculosis trials