PanACEA - STEP2C -01

Pulmonary Tuberculosis Clinical Trial

Official title: A Multiple Arm, Multiple Stage (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 BTZ-043, in Adults With Newly Diagnosed, Drug Sensitive, Smear-positive Pulmonary Tuberculosis.

Status Recruiting

Clinical Trial Summary

This is a phase 2B/C, open label platform study that will compare the efficacy, safety of 3 experimental regimens with a standard control regimen in participants with newly diagnosed, drug sensitive pulmonary tuberculosis. In stage 1, participants will be randomly allocated to the control or one of the 2 rifampicin-containing experimental regimens in the ratio 1:1:1. In stage 2, the experimental arm 4 containing BTZ-043 will be added. The allocation ratio will be changed to co-enrol the remaining participants in arms 1- 3 simultaneously with arm 4. When arms 1-2 are fully enrolled and arm 4 is not, further participants will be randomized 1:1 to control and experimental arm 4. Not all countries will participate in stage 2.

Clinical Trial Description

This open label, phase 2B/C , randomized, controlled platform trial, will evaluate experimental arms including an increased dose of rifampicin, on optimized dose of pyrazinamide, moxifloxacin and BTZ-043, in adults with newly diagnosed, drug sensitive, smear-positive pulmonary tuberculosis A total of up to 270 adult (≥ 18 years of age) participants will be enrolled. In case of a high number of dropouts or non-evaluable participants, it may be necessary to recruit more participants into the study. Also, if the stage 2 starts later than stage 1, it may be necessary to increase the number of control arm participants to achieve a 1:1 ratio of concomitantly recruited control and arm 4 participants until the recruitment for arm 4 is completed (see sample size considerations). ;

Related Conditions & MeSH terms

• Other Specified Pulmonary Tuberculosis
• Pulmonary Tuberculosis
• Tuberculosis
• Tuberculosis, Pulmonary

• NCT number: NCT05807399
• Study type: Interventional
• Source: Ludwig-Maximilians - University of Munich
• Contact: Norbert Heinrich, PD Dr.
• Phone: +49894400
• Email: Norbert.Heinrich@med.uni-muenchen.de
• Status: Recruiting
• Phase: Phase 2
• Start date: April 14, 2023
• Completion date: February 23, 2025