NCT02114684

Improving Retreatment Success (IMPRESS)

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 197 (actual)
• Sponsor: Centre for the AIDS Programme of Research in South Africa · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Recurrent Tuberculosis

Interventions

Type	Name	Description
DRUG	moxifloxacin	\[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)\]

Timeline

• Start date: 2013-11-01
• Primary completion: 2017-07-01
• Completion: 2017-07-17
• First posted: 2014-04-15
• Last updated: 2019-08-05
• Results posted: 2019-08-05

Locations

1 site across 1 country: South Africa