Patient-reported Experiences & Quality of Life Outcomes in

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Multidrug Resistant Tuberculosis
Tuberculosis
Tuberculosis, Multidrug-Resistant

Clinical Trial Details

NCT number	NCT03942354
Study type	Interventional
Source	Medecins Sans Frontieres, Netherlands
Contact	Nicola James, MSc
Phone	+44 2070674255
Email	nicola.james@london.msf.org
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	September 1, 2019
Completion date	October 31, 2022

View Details

See also
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Recruiting	`NCT05081401` - Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
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Completed	`NCT00727844` - Linezolid to Treat Extensively-Drug Resistant Tuberculosis	Phase 2
Completed	`NCT01859923` - A 6-Month Safety, Efficacy, and Pharmacokinetic (PK) Trial of Delamanid in Pediatric Participants With Multidrug Resistant Tuberculosis (MDR-TB)	Phase 2
Active, not recruiting	`NCT04421495` - Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China	Phase 4
Active, not recruiting	`NCT04717908` - Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T)-PLUS	N/A
Not yet recruiting	`NCT03604848` - NGS-Guided(G) Regimens(R) of Anti-tuberculosis(A) Drugs for the Control(C) and Eradication(E) of MDR-TB	N/A
Recruiting	`NCT02120638` - Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide	Phase 3
Recruiting	`NCT05534750` - Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)	Phase 2

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms