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Improving Retreatment Success (IMPRESS) (IMPRESS)

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ClinicalTrials.gov Identifier: NCT02114684
Recruitment Status : Completed
First Posted : April 15, 2014
Results First Posted : August 5, 2019
Last Update Posted : August 5, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Nesri Padayatchi, Centre for the AIDS Programme of Research in South Africa

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.

Condition or disease Intervention/treatment Phase
Recurrent Tuberculosis Drug: moxifloxacin Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : November 2013
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 17, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Arm Intervention/treatment
Active Comparator: 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.

Drug: moxifloxacin
[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)]
Other Name: AVELON

Active Comparator: 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.

Drug: moxifloxacin
[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)]
Other Name: AVELON




Primary Outcome Measures :
  1. Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation [ Time Frame: 24 weeks ]
    The proportion of patients with negative sputum cultures at the end of the intensive phase (8 weeks) and the proportion of patients with negative sputum cultures at 6 months were compared between the two study arms. All participants with sputum culture results at week 8 and month 6 were included in the analysis.


Secondary Outcome Measures :
  1. Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen [ Time Frame: Up to 2 years ]
    To determine the time to culture-conversion of the moxifloxacin regimen and the ethambutol regimen.

  2. Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms [ Time Frame: Up to 2 years ]
    To compare the proportion of patients with any Grade 3 or 4 adverse reactions in the two study arms. Outcome measured in terms of number of participants with at least one grade 3 or 4 events, and not in number of events.

  3. Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients [ Time Frame: up to 2 years for adverse events and 8 weeks for culture conversion rates ]
    To compare adverse events and 8-week culture conversion rates among HIV-infected patients vs. HIV-uninfected patients. The proportion of participants with at least one grade 3 or 4 adverse event was measured.

  4. Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm. [ Time Frame: up to 2 years ]
    A patient was defined as having an unfavourable outcome if he/she was not cured at the end of treatment or did not successfully complete treatment. Recurrence after completion of treatment was defined as two positive cultures within a period of four months without an intervening negative culture.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02114684


Locations
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South Africa
CAPRISA eThekwini Clinical Research Site (eCRS)
Durban, KwaZulu Natal, South Africa, 4001
Sponsors and Collaborators
Centre for the AIDS Programme of Research in South Africa
Investigators
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Principal Investigator: Nesri Padayatchi, MBChB, MSc Centre for the AIDS Programme of Research in South Africa
Study Director: Kogieleum Naidoo, MBChB Centre for the AIDS Programme of Research in South Africa
  Study Documents (Full-Text)

Documents provided by Dr Nesri Padayatchi, Centre for the AIDS Programme of Research in South Africa:
Study Protocol  [PDF] May 11, 2015
Statistical Analysis Plan  [PDF] November 2, 2018


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Nesri Padayatchi, Principle Investigator, Centre for the AIDS Programme of Research in South Africa
ClinicalTrials.gov Identifier: NCT02114684     History of Changes
Other Study ID Numbers: CAP 011
First Posted: April 15, 2014    Key Record Dates
Results First Posted: August 5, 2019
Last Update Posted: August 5, 2019
Last Verified: June 2019
Additional relevant MeSH terms:
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Moxifloxacin
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Isoniazid
Pyrazinamide
Ethambutol
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antitubercular Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents