Clinical Trials Logo
  1. Home
  2. Multidrug Resistant Tuberculosis
  3. NCT03942354

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

Multidrug Resistant Tuberculosis Clinical Trial

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

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

Clinical Trial Details
NCT number NCT03942354
Study type Observational
Source Medecins Sans Frontieres, Netherlands
Contact
Status Completed
Phase
Start date September 1, 2019
Completion date May 10, 2022
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT05017324 - Sequencing Mycobacteria and Algorithm-determined Resistant Tuberculosis Treatment Trial N/A
Active, not recruiting NCT02496572 - Effectiveness of a Simplified Short Regimen for Multidrug Resistant Tuberculosis in Uzbekistan Phase 3
Completed NCT02454205 - An Open-label RCT to Evaluate a New Treatment Regimen for Patients With Multi-drug Resistant Tuberculosis Phase 2/Phase 3
Recruiting NCT05081401 - Innovating(IN) Shorter(S), All- Oral, Precised(P), Individualized(I) Treatment Regimen(RE) for Rifampicin Resistant Tuberculosis(INSPIRE-TB)
Completed NCT01856634 - Pharmacokinetic and Safety Trial to Determine the Appropriate Dose for Pediatric Patients With Multidrug Resistant Tuberculosis Phase 1
Active, not recruiting NCT03867136 - Refining MDR-TB Treatment (T) Regimens (R) for Ultra(U) Short(S) Therapy(T) Phase 4
Not yet recruiting NCT04484129 - MDR-TB Close Contacts Tracing in China (TCCT Study)
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