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Recurrent TuberculosisPhase 1/2IMPRESSNCT02114684

Improving Retreatment Success (IMPRESS)

A Phase 1/2 study testing moxifloxacin in people with Recurrent Tuberculosis, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent Tuberculosis
What is being tested?
moxifloxacin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
197 participants
Where
1 siteSouth Africa
Study dates
Nov 2013to 17 Jul 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Africa1 site

  • CAPRISA eThekwini Clinical Research Site (eCRS)

    Durban, KwaZulu-Natal, 4001

Other trials in South Africa

About this study

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

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.

Read the 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.

Being tested
moxifloxacin
Medical subject headings
Tuberculosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • moxifloxacinDrug

    Also called AVELON

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

Study groups in NCT02114684
Study groupRoleWhat they receive
MoxifloxacinActive comparatorA 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.
Receives: Drug: moxifloxacin
EthambutolActive comparatorAn 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.
Receives: Drug: moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation

    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.

    Measured: 24 weeks

Secondary outcomes (4)

  1. Time to Culture-conversion of the Moxifloxacin Regimen and the Ethambutol Regimen

    To determine the time to culture-conversion of the moxifloxacin regimen and the ethambutol regimen.

    Measured: Up to 2 years

  2. Proportion of Patients With Any Grade 3 or 4 Adverse Reactions in the Two Study Arms

    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.

    Measured: Up to 2 years

  3. Number of Participants With Adverse Events and 8-week Culture Conversion Rates Among HIV-infected Patients vs. HIV-uninfected Patients

    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.

    Measured: up to 2 years for adverse events and 8 weeks for culture conversion rates

  4. Proportion of Patients With Unfavourable Outcomes or Tuberculosis Recurrence in the Moxifloxacin and Control Arm.

    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.

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Apr 2014 (estimated)
  2. Study startNov 2013
  3. Primary completionJul 2017
  4. Study completion17 Jul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
197 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02114684
Sponsor's protocol ID
CAP 011
Acronym
IMPRESS
Status last verified
Jun 2019
First submitted
29 Jan 2014
Last updated
5 Aug 2019
Data monitoring committee
No

Publications

  • Rambaran S, Maseko TG, Lewis L, Hassan-Moosa R, Archary D, Ngcapu S, Garrett N, McKinnon LR, Padayatchi N, Naidoo K, Sivro A. Blood monocyte and dendritic cell profiles among people living with HIV with Mycobacterium tuberculosis co-infection. BMC Immunol. 2023 Jul 21;24(1):21. doi: 10.1186/s12865-023-00558-z.

    PubMed 37480005

  • Perumal R, Padayatchi N, Yende-Zuma N, Naidoo A, Govender D, Naidoo K. A Moxifloxacin-based Regimen for the Treatment of Recurrent, Drug-sensitive Pulmonary Tuberculosis: An Open-label, Randomized, Controlled Trial. Clin Infect Dis. 2020 Jan 1;70(1):90-98. doi: 10.1093/cid/ciz152.

    PubMed 30809633

  • Naidoo A, Chirehwa M, Ramsuran V, McIlleron H, Naidoo K, Yende-Zuma N, Singh R, Ncgapu S, Adamson J, Govender K, Denti P, Padayatchi N. Effects of genetic variability on rifampicin and isoniazid pharmacokinetics in South African patients with recurrent tuberculosis. Pharmacogenomics. 2019 Mar;20(4):225-240. doi: 10.2217/pgs-2018-0166. Epub 2019 Feb 15.

    PubMed 30767706

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing moxifloxacin in people with Recurrent Tuberculosis, run by Centre for the AIDS Programme of Research in South Africa at 1 site in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sputum Culture Conversion Rates at Week 8 and Month 6 Post Tuberculosis Treatment Initiation (time frame: 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02114684, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2019.

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