Controlled comparison of two moxifloxacin containing treatment shortening regimens in pulmonary tuberculosis
Can we shorten the amount of time people have to take drugs to treat TB?
What was this study about?
People who have tuberculosis in their lungs (pulmonary TB) are usually treated with a number of drugs for six to eight months. But this is a long time for people to take these drugs, and some people find it hard to keep taking the drugs until their course of treatment is finished. This means that the TB may come back, or that they still carry the TB bacteria in their sputum – so they can pass the disease to other people.
The commonly used drugs to treat TB are rifampicin, isoniazid, ethambutol and pyrazinamide. Research done in mice and on humans suggests that a drug called moxifloxacin which is already licensed to treat other infectious diseases may be used substituted for one of these drugs to treat TB effectively. The trial will test whether a course of treatment including moxifloxacin taken for four months, will be no less effective than the currently used combination of drugs, taken for six to eight months
What difference did this study make?
The two moxifloxacin-containing regimens, given for 4-months, produced a more rapid initial decline in bacterial load when compared with the 6-month control group.
However, neither of these regimens was as effective as the control regimen in terms of long-term outcomes. The failure to demonstrate non-inferiority was consistent across a wide range of sub-groups and with the results of the 4-month moxifloxacin and rifapentine based regimen studied in the RIFAQUIN trial.
The study provided valuable information on the use of alternative culture media namely Lowenstein-Jensen solid medium and liquid medium in a Mycobacteria Growth Indicator Tube (MGIT)
Type of study
Who funded the study?
This trial is funded by the European and Developing Countries Clinical Trials Partnership (EDCTP), the TB Alliance in the USA and by two pharmaceutical companies - Bayer HealthCare Pharmaceuticals and Sanofi-Aventis.
When did it take place?
This trial began recruitment in January 2008 and completed recruitment in January 2012.
Where did it take place?
Initially in five centres in South and East Africa – Lusaka in Zambia; Durban, Stellenbosch and Cape Town in South Africa and Moshi in Tanzania although additional centres were added in South Africa, Tanzania, Kenya, Thailand, Malaysia, Mexico, India and China.
Who was included?
This trial successfully completed recruitment of 1931 patients with pulmonary TB.