Phase 2
N=196
Improving Retreatment Success (IMPRESS)
Recurrent Tuberculosis
Bottom Line
View on ClinicalTrials.gov: NCT02114684 ↗Enrolled (actual)
196
Serious AEs
19.9%
Results posted
Aug 2019
Primary outcome: Primary: Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation — 78; 73; 84; 92 Participants — p=0.46
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- moxifloxacin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Centre for the AIDS Programme of Research in South Africa
- Primary completion
- Jul 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation |
78; 73; 84; 92 | 0.46 |
| SECONDARY Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen |
6.0; 7.9 | 0.018 sig |
| SECONDARY Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms |
43; 25 | 0.011 sig |
| SECONDARY Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients |
30; 19; 13; 6; 57; 51 | 0.01 sig |
| SECONDARY Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm. |
13; 6 | 0.15 |
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.
Eligibility Criteria
Inclusion Criteria
- Adults ≥ 18 years of age
- Previous history of anti-TB chemotherapy
- HIV status: HIV infected and uninfected patients are allowed in the study:
- All patients must agree to HIV testing to confirm HIV status.
- Patients already on ARVs will be allowed in the study provided that the ART regimen is not contraindicated with any of the study agents .
- HIV infected patients at any CD4 count irrespective of ART commencement and duration will be included in the study
- Smear positive or Gene Xpert positive pulmonary tuberculosis
- Rifampicin susceptible as determined by Gene Xpert at screening. Gene Xpert will be used to determine rifampicin resistance, hence the study team will made aware of resistance within 48 hours and prior to study enrolment.
- Karnofsky score greater than 70
- Female candidates of reproductive potential must agree to use two reliable methods of contraception while on study: a barrier method of contraception (condoms or cervical cap) together with another reliable form of contraceptive (condoms with a spermicidal agent, a diaphragm or cervical cap with spermicide, an Intrauterine Device (IUD), or hormone-based contraceptive)
- A negative pregnancy test
- Laboratory parameters done at, or 14 days prior to, screening:
- Haemoglobin level of at least 7.0 g/dL
- Serum aspartate transaminase (AST) and alanine transaminase (ALT) activity less than 3 times the upper limit of normal
- Serum total bilirubin level less than 2.5 times upper limit of normal
- Creatinine clearance (CrCl) level greater than 60 mls/min
- Platelet count of at least 50 x109cells/L
- Serum potassium greater than 3.0 mmol/L
Exclusion Criteria
- Patients on a Nevirapine (NVP)-containing ART regimen at screening
- Pregnant or breastfeeding
- Received an antibiotic active against M. tuberculosis in the last 14 days (e.g. fluoroquinolones, macrolides, standard anti-tuberculosis drugs).
- Patients with known M. tuberculosis resistance to any of the study drugs at screening
- History of prolonged QT syndrome or current or planned therapy with quinidine, procainamide, amiodarone, sotalol, or ziprasidone during the intensive phase of tuberculosis treatment.
- Known allergies or intolerance to any of the study drugs.
Data sourced from ClinicalTrials.gov (NCT02114684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.