PanACEA has a strong history of well conducted clinical trials to evaluate new regimens for the treatment of drug sensitive TB. Our studies range from small two-center early Phase IIA studies through to large-scale Phase III studies in a multitude of sites and countries. At the start of the consortium, separate development programmes were conducted for each of the drugs in our portfolio (at the time moxifloxacin, rifampicin and SQ109). These programmes have since come together with a particular emphasis on regimen development and, introducing the Multi-Arm Multi-Stage (MAMS) study design, has set a new standard in TB combination therapy research, investigating all three drugs in different regimes in one trial. We continue to employ innovative methodology and biomarkers to design more efficient trials and speed the development of new regimens.

AcronymStudy IdentifierFirst Patient RecruitedTotal PatientsDrugs/Regimens StudiedTrial Design
REMoxStephen GillespieNCT0086438318 January 20081931 patientsRapid Evaluation of Moxifloxacin in Tuberculosis in cooperation with GTBAPhase III
HR1Martin Boeree Rob Aarnoutse NCT0139291109 June 201181 patientsRapid Evaluation of High-Dose Rifampicin and other Rifamycins in TuberculosisPhase IIA
HR2Rob Aarnoutse Martin Boeree NCT0076014913 August 2010150 patientsRapid Evaluation of High-Dose Rifampicin and other Rifamycins in TuberculosisPhase IIB
SQ109 EBAMichael HölscherNCT01218217201090 patientsEvaluation of a Novel TB Drug (SQ109) to Shorten and Simplify Tuberculosis TreatmentPhase IIA
MAMS-TBMartin Boeree Michael HölscherNCT0178518607 May 2013365 patientsA multiple arm, multiple stage (MAMS) trial to evaluate four treatment regimens including SQ109, two increased doses of rifampicin and moxifloxacinPhase IIB
BTZ-043-02Michael Hölscher Patrick PhilipsNCT0404400115 November 201977 patientsEvaluation of the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of Multiple Oral Doses of BTZ-043 Tablets in Subjects With Newly Diagnosed, Uncomplicated, Smear-positive, Drug-susceptible Pulmonary TuberculosisPhase IB/IIA
PHENORIFRob Aarnoutse--25 patientsThe Effect of High Dose Rifampicin on the Activity of Cytochrome P450 Enzymes and P-glycoprotein in Subjects With Pulmonary Tuberculosis: a Cocktail Phenotyping StudyDrug-drug interaction study
SUDOCUNorbert HeinrichNCT03959566-75 patientsOpen-Label, Randomized Controlled Dose Ranging Multi-Center Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Exposure-
Response Relationship of different doses of Sutezolid in combination with Bedaquiline, Delamanid and Moxifloxacin in Adult Subjects with Newly Diagnosed, Uncomplicated, Smear-Positive, Drug-sensitive Pulmonary Tuberculosis
Phase IIB
DECODE Norbert HeinrichNCT04550832February 202275 patients Delpazolid dose-finding and combination development Phase II
STEP2CMichael Hölscher
Martin Boeree
--360 patientsMultiple arm trial to evaluate treatment regimens high dose RIF, high dose PZA in addition to an arm including an optimized dose of sutezolid.Phase IIC Selection Trial with Extended Post-treatment follow-up (STEP) trial design

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