Pulmonary Tuberculosis (TB) Clinical Trial
Official title:
A Phase IIA Dose Ranging Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of Higher Doses of Rifampicin in Adult Subjects With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis
This is the first trial in a series of clinical trials that aim to bring the concept of high
dose rifampicin beyond phase II of clinical development.
The safety, tolerability, extended early bactericidal activity (EBA) and pharmacokinetics of
several doses of Rifampicin with or without standard doses of Isoniazid, Pyrazinamide and
Ethambutol in adults with newly diagnosed, uncomplicated, smear positive, pulmonary TB will
be assessed. The objective of this study is to find the maximum tolerable dose of Rifampicin
as monotherapy and in combination with the currently available Isoniazid, Pyrazinamide and
Ethambutol.
The subjects will be in the study for 24-31 days. After a screening period of 9-3 days, the
subjects will receive treatment with Rifampicin as single drug during 7 days (monotherapy).
This treatment will be followed by treatment with 7 days of Rifampicin and Isoniazid,
Pyrazinamide and Ethambutol (combination therapy), and 7-8 days treatment with standard TB
medication.
All subjects will be closely monitored for side effects. This monitoring will include daily
interviews and physical examination, and ECG evaluation and blood and urine analyses at
specific intervals.
During the 7 days of monotherapy, after the second day of the combination therapy and at the
end of the combination therapy, overnight sputum will be collected from the patients to
investigate the potency of high dose rifampicin to reduce this number of bacilli.
The Rifampicin dose will be increased step by step and group by group. The control group will
receive the standard dose of 10 mg Rifampicin/kg, whereas the first treatment group will
receive 20 mg/kg. The Rifampicin dose will only be further increased for a next group of
patients, if this is expected to be safe.
Rifampicin is widely available and not expensive. Physicians all over the world have
experience with this drug and its adverse effects. Should this study be successful, the
highest dose of Rifampicin that this safe and tolerable will be given to a larger group of
patients. in the next study.
If increasing the dose of Rifampicin proves to be safe and effective, a higher dose of
Rifampicin could be implemented broadly and quickly, and it would benefit many patients
worldwide.
n/a
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01698476 -
Immune Reconstitution in Tuberculosis Disease
|
Phase 2 |