An international multicentre controlled clinical trial to evaluate high dose rifapentine and a quinolone in the treatment of pulmonary tuberculosis
Can people who have TB in their lungs take less drugs for a shorter time or less frequently?
What was this study about?
The current treatment of tuberculosis involves taking drugs daily for 6 or 8 months. Although the drugs are free to patients in low income countries, this still involves a substantial cost, in terms of time and administration, to both the patient and the treatment services. If the length of treatment could be shortened to 4 months, or treatment administration simplified by, for example, being given once or twice weekly rather than daily, this would be of great benefit to the patients and the treatment services.
In this trial, we are assessing whether rifapentine (a rifamycin) and moxifloxacin (a quinolone), when given together, can achieve these objectives. Shortening of simplifying treatment may improve overall patient adherence to treatment and therefore outcome.
What difference did this study make?
The results in the 4-month regimen with a twice -weekly continuation phase were disappointing; relapse rates were significantly higher than those in the 6-month control regimen. This finding is consistent with the REMoxTB trial which also failed to demonstrate that moxifloxacin could shorten treatment without loss of efficacy.
In contrast the 6-month regimen was as effective as the control regimen. It offers the prospect of a new regimen requiring considerably fewer days of treatment in the two month continuation phase, which was administered once-weekly, as compared to the control regimen, which was given daily throughout the treatment.
Another important advantage of the 6-month regimen is that it should be equally effective in patients with tuberculosis that is resistant to isoniazid alone, as it doesn't contain this drug.
Type of study
Who funded the study?
This trial is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP).
When did it take place?
The trial started recruitment in August 2008.
The last patient visit took place at the end of July 2012. Database lock is scheduled for December 2012 and we expect to release the trial results publicly in the early part of 2013.
Where did it take place?
In 6 sites across Southern Africa – in South Africa, Zambia, Botswana and Zimbabwe.
Who was included?
Adults with pulmonary TB which has been recently diagnosed. We aim to recruit 1100 people.