Trial | NCT03942354  Report issue

Official Title

Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    54
PRACTECAL-PRO is a sub-study of a TB-PRACTECAL clinical trial for multidrug resistant Tuberculosis. It evaluates the effectiveness of TB-PRACTECAL interventions from the patient perspective in terms of their quality of life, shared decision making and satisfaction with services.
Tolerability of drugs for TB is a complex and dynamic course for patients with drug resistance and can be affected by many different factors. A deeper understanding of the perspectives and experience of men and women participating in novel TB treatment trials will add to the understanding of the safety and efficacy of treatment.

TB-PRACTECAL is a multicentre, open label, phase 2-3 randomised controlled trial evaluating exclusively oral 6 months regimens containing bedaquiline, pretomanid, linezolid +/- moxifloxacin or clofazimine for the treatment of microbiologically confirmed pulmonary M/XDR-TB. It is registered with the ClinicalTrials.gov with identifier number NCT02589782. The trial aims to recruit 630 adults from two sites in Uzbekistan (Nukus and Tashkent) and one site each from Belarus and South Africa.

The TB-PRACTECAL trial assumes that even if the investigational arms would have non-inferior efficacy and safety compared to the standard of care outcomes, patients would prefer a shorter, exclusively oral regimen with a lower pill count. This study therefore aims to describe patient experiences (i.e. the quality of the treatment experience as opposed to the quantity of treatment or the amount of time spent on it).

The PRACTECAL-PRO sub-study aims to answer the question: "What are the perceptions, expectations and experiences of novel TB treatment for adult patients participating in a six-month regimen clinical trial in Uzbekistan, South Africa and Belarus?"

The objectives for the analysis are:

To compare baseline scores between trial patients (all interventional arm patients plus standard of care patients) with healthy controls.
To assess changes in scores over time in patients on the intervention arms and patients on the standard of care arm.
To assess the utility of the SF 12 and SGRQ in a TB clinical trial.
Study Started
Sep 01
2019
Primary Completion
Sep 30
2022
Anticipated
Study Completion
Oct 31
2022
Anticipated
Last Update
May 13
2021

Drug Bedaquiline

Bedaquiline is a diarylquinoline class antimicrobial which blocks the proton pump for ATP synthase of mycobacteria. This in turn blocks the ATP production required for cellular energy production and leading to cell death.

  • Other names: Sirturo, R207910, TMC207

Drug Pretomanid

Pretomanid is a nitroimidazole class antimicrobial which interferes with cell wall biosynthesis in mycobacteria. It may have other mechanisms of action as well in non-replicating mycobacteria.

  • Other names: PA-824

Drug Moxifloxacin

Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria

  • Other names: Avelox, BAY 12-8039

Drug Linezolid

Linezolid, an oxazolidinone class antimicrobial which works by inhibiting ribosomal protein synthesis. It is approved for Gram-positive bacterial infections, and is increasingly being used for drug resistant TB disease.

  • Other names: Zyvox

Drug Clofazimine

Clofazimine is a lipophilic riminophenazine licensed for treatment of leprosy. Its mechanism(s) of action remains unclear, but existing evidence suggests production of reactive oxygen species within Mycobacterium tuberculosis is one mechanism.

  • Other names: Lamprene

Drug Directly observed therapy (DOT)

Standard therapy

Intervention arm Experimental

A total of 72 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan.

Standard therapy Active Comparator

72 standard therapy trial patients (from TB-PRACTECAL trial) will be recruited across all three sites. Patients will complete measures at baseline, 3 months, 6 months and 12 months.

Criteria 

Inclusion Criteria:

Patients recruited into the TB-PRACTECAL trial in the approved sites OR
Local healthy-controls of a similar profile in terms of age and gender aged ≥18 years AND
Literate in the study questionnaire languages
Able to sign the sub-study informed consent form after agreeing to the additional interviews and completion of questionnaires.

Exclusion Criteria:

TB patients excluded from TB-PRACTECAL clinical trial
Healthy volenteers with co-morbidities
Healthy volenteers found to have TB
No Results Posted