Controlled platform trial to evaluate experimental arms - "MAMS STEP2C"

The project's full title is: “A multiple arms, multiple stages (MAMS) PHASE 2b/c, Open Label, randomized controlled platform trial to evaluate experimental arms including an increased dose of rifampicin, an optimized dose of pyrazinamide, moxifloxacin, and sutezolid, in adults with newly diagnosed, drug-sensitive, smear-positive pulmonary tuberculosis.” 

The aim of the project as a step 2C trial, is to investigate the safety and tolerability of a new drug called Sutezolid drugs and also test the efficacy of the combination of drugs in treating patients with Pulmonary Tuberculosis. Normally, TB treatment usually takes up to 6 months and one objective of the study is to shorten the treatment period to at least 3 months.

As a Multicentric study, implementation will be conducted in six African countries - Tanzania, South Africa, Malawi, Mozambique Uganda, and Gabon.

In Tanzania, the study sites will include Mbeya, Kilimanjaro (Kilimanjaro Clinical Research Institute, KCRI), and Dar es Salaam (Mwananyamala Hospital) and will also involve collaborators from Palestina Hospital and Tandale Hospital, who will be taking patients from Zakiem.

Additionally, satellite clinics will also be used during the study to accommodate patients recruited to participate in the study. They will include Bunju Hospital and Mbweni, Kiwangwa in Bagamoyo, as well as others in Mlandizi, and Kibaha.  

The study duration is 36 months (from April 2023 to April 2026) and will be funded by EDCTP through Klinikum der Universitat Munchen and Stitching Radboud universitair medisch centrum.