Trials · 2026
A pragmatic trial with an optimized dose of rifampicin and moxifloxacin for the treatment of drug-susceptible pulmonary tuberculosis: a study protocol for open-label, randomized phase III trial (OptiRiMoxTB).
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Mlyuka Hamu J, Liyoyo Alphonce, Nyaulingo Belinda, Mpolya Emmanuel, Kaswaga Oscar L, Semvua Hadija, Lwambura Samwel, McHugh Tim D, Wildner Leticia, Sabiiti Wilber, Adegbite Bayode R, Nliwasa Marriot, Khosa Celso, Mbelele Peter, Mbeya Benno, Jeremiah Kidola, Boeree Martin J, Gillespie Stephen H, Sloan Derek J, Mpagama Stellah G, SimpliciTB Consortium
Аннотация
BACKGROUND: Current combination antibiotic treatment for drug-susceptible tuberculosis (DS-TB) usually takes 6 months to complete. This long duration can compromise clinical outcomes. Although a 4-month regimen including an optimized dose of rifapentine plus moxifloxacin is non-inferior to standard therapy, rifapentine is hard to source globally and adoption of this regimen has been slow. This trial investigates the efficacy and safety of a 4-month DS-TB treatment including the more readily available rifamycin, rifampicin 35 mg/kg, with or without moxifloxacin 400 mg.
METHODS: This multi-centre phase III randomized open-label clinical trial will be conducted across four African countries (Gabon, Malawi, Mozambique and Tanzania). A total of 414 newly diagnosed consenting adult participants will be block randomized, after stratification by chest radiograph cavitation, to two experimental and one control arm at a ratio of 1:1:1. The first experimental group will receive optimized dose rifampicin (35 mg/kg) with routine weight-banded doses of isoniazid, pyrazinamide, and ethambutol once daily for 4 months. The second experimental group will receive optimized dose rifampicin (35 mg/kg) and moxifloxacin 400 mg once daily alongside routine doses of isoniazid and pyrazinamide. The control group will receive 6-month standard of care therapy: rifampicin (10 mg/kg) plus weight-banded dose of isoniazid, pyrazinamide, and ethambutol for 2 months, followed by the same doses of rifampicin and isoniazid for 4 months. Participants will be followed until the allocation of efficacy (TB-free survival) and safety (proportion of severe adverse events) outcomes. Secondary outcomes will also include the evaluation of the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) for microbiological treatment monitoring.
DISCUSSION: This study will evaluate whether 4-month duration multi-drug treatment including an optimized dose of rifampicin with or without moxifloxacin has non-inferior efficacy and safety outcomes compared to standard of care DS-TB therapy in Africa.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05575518. Registered on 10th October 2022.
METHODS: This multi-centre phase III randomized open-label clinical trial will be conducted across four African countries (Gabon, Malawi, Mozambique and Tanzania). A total of 414 newly diagnosed consenting adult participants will be block randomized, after stratification by chest radiograph cavitation, to two experimental and one control arm at a ratio of 1:1:1. The first experimental group will receive optimized dose rifampicin (35 mg/kg) with routine weight-banded doses of isoniazid, pyrazinamide, and ethambutol once daily for 4 months. The second experimental group will receive optimized dose rifampicin (35 mg/kg) and moxifloxacin 400 mg once daily alongside routine doses of isoniazid and pyrazinamide. The control group will receive 6-month standard of care therapy: rifampicin (10 mg/kg) plus weight-banded dose of isoniazid, pyrazinamide, and ethambutol for 2 months, followed by the same doses of rifampicin and isoniazid for 4 months. Participants will be followed until the allocation of efficacy (TB-free survival) and safety (proportion of severe adverse events) outcomes. Secondary outcomes will also include the evaluation of the Tuberculosis Molecular Bacterial Load Assay (TB-MBLA) for microbiological treatment monitoring.
DISCUSSION: This study will evaluate whether 4-month duration multi-drug treatment including an optimized dose of rifampicin with or without moxifloxacin has non-inferior efficacy and safety outcomes compared to standard of care DS-TB therapy in Africa.
TRIAL REGISTRATION: ClinicalTrials.gov NCT05575518. Registered on 10th October 2022.
Предметные рубрики MeSH
AdultFemaleHumansMaleAntibiotics, AntitubercularAntitubercular AgentsClinical Trials, Phase III as TopicDrug Therapy, CombinationEthambutolIsoniazidMoxifloxacinMulticenter Studies as TopicPyrazinamideRandomized Controlled Trials as TopicRifampinTime FactorsTreatment OutcomeTuberculosis, PulmonaryPragmatic Clinical Trials as Topic