Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05807399
Status:
RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-02-14
Brief Title:
PanACEA - STEP2C -01
Sponsor:
Michael Hoelscher
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
A Multiple Arm Multiple Stage MAMS Phase 2BC 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
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a phase 2BC 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 111 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 11 to control and experimental arm 4 Not all countries will participate in stage 2
Detailed Description:
This open label phase 2BC 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 11 ratio of concomitantly recruited control and arm 4 participants until the recruitment for arm 4 is completed see sample size considerations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None