Ignite Creation Date:
2024-05-06 @ 2:45 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02114684
Status:
COMPLETED
Last Update Posted:
2019-08-05
First Post:
2014-01-29
Brief Title:
Improving Retreatment Success IMPRESS
Sponsor:
Centre for the AIDS Programme of Research in South Africa
Organization:
Centre for the AIDS Programme of Research in South Africa
Study Overview
Official Title:
An Open Label Randomized Controlled Clinical Trial Comparing a 24Week Oral Regimen Containing Moxifloxacin With a 24 Week Standard Drug Regimen for the Treatment of Smear-positive Pulmonary Tuberculosis in Patients Previously Treated for TB
Status:
COMPLETED
Status Verified Date:
2019-06
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:
IMPRESS
Brief Summary:
This is an open label randomized controlled clinical trial comparing two regimens for treatment of smear-positive pulmonary TB among patients previously treated for TB The primary objective is to determine if a moxifloxacin-containing regimen substituting moxifloxacin for ethambutol of 24 weeks duration is superior to a control regimen of 24 weeks duration in improving treatment outcomes in patients with recurrent TB and shortens the duration of TB treatment
Detailed Description:
Intervention Arm 12 months 6 months treatment 12 months post treatment follow up Control Arm 12 months 6 months treatment 12 months post treatment follow up Total sample size is 330
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None