Improving Retreatment Success (IMPRESS)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2017-07-17

Brief Summary

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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.

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Detailed Description

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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

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Recurrent Tuberculosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Moxifloxacin

A Moxifloxacin-containing oral regimen of Isoniazid (H), Rifampicin (R), Pyrazinamide (Z), Moxifloxacin (M), substituting Moxifloxacin for Ethambutol, daily for 24 weeks, see information below.

Intensive phase 7 days a week for 8 weeks Continuation phase - 7 days a week for 16 weeks

RH(150,75mg), Z (500mg), M (400mg) Dosage and number of tablets dispensed is dependent on participants weight band.

Group Type ACTIVE_COMPARATOR

moxifloxacin

Intervention Type DRUG

\[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)\]

Ethambutol

An Ethambutol oral regimen of Isoniazid (H), Rifampicin(R), Pyrazinamide (Z), Ethambutol(E), daily for 24 weeks duration, substituting Ethambutol for Moxifloxacin.

Intensive phase 7 days a week for 8 weeks Continuation phase - 7 days a week for 16 weeks.See details below.

(150,75,400,275 mg) RHZE Dosage and number of tablets dispensed is dependent on participants weight band.

Group Type ACTIVE_COMPARATOR

moxifloxacin

Intervention Type DRUG

\[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)\]

Interventions

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moxifloxacin

\[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)\]

Intervention Type DRUG

Other Intervention Names

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AVELON

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No