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

Medecins Sans Frontieres, Netherlands

Status and phase: Completed; Phase 3; Phase 2

Conditions: Multidrug Resistant Tuberculosis

Treatments: Drug: Clofazimine; Drug: Pretomanid; Drug: Directly observed therapy (DOT); Drug: Bedaquiline; Drug: Moxifloxacin; Drug: Linezolid

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT03942354

PRACTECAL-PRO

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 137 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

137 participants in 2 patient groups

Intervention arm

Description:

A total of 54 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan. 54 matched healthy controls are anticipated.

Treatment:

Drug: Linezolid

Drug: Moxifloxacin

Drug: Bedaquiline

Drug: Clofazimine

Drug: Pretomanid

Standard therapy

Description:

54 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. 54 matched healthy controls are anticipated.

Treatment:

Drug: Directly observed therapy (DOT)