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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/16/2021.

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

Clinicaltrials.gov identifier NCT03942354

Recruitment Status Not yet recruiting

First Posted May 8, 2019

Last update posted August 30, 2019

Study Description

Brief 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.

  • Condition or Disease:Multidrug Resistant Tuberculosis
  • Intervention/Treatment: Drug: Bedaquiline
    Drug: Pretomanid
    Drug: Moxifloxacin
    Drug: Linezolid
    Drug: Clofazimine
    Drug: Directly observed therapy (DOT)
  • Phase: Phase 2/Phase 3
Detailed 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
  • Study Type: Interventional
  • Estimated Enrollment: 54 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
  • Estimated Study Start Date: September 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: March 2021
Arms and interventions
Arm Intervention/treatment
Experimental: Intervention arm
A total of 72 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan.
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.

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.

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

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.

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.
Active Comparator: Standard therapy
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.
Drug: Directly observed therapy (DOT)
Standard therapy
Outcome Measures
  • Primary Outcome Measures: 1. Change in St George's respiratory questionnaire SGRQ survey questionnaire from baseline to 12 months [ Time Frame: 12 months ]
    To assess the quality of life (QoL) of trial patients from baseline to 12 months: both those treated in the investigational arms and the standard of care arm. For the SGRQ, a change of 4 points is suggested to indicate a clinically significant change, although the questionnaire was developed with patients who had COPD rather than TB. In the sub-study with a relatively small sample we cannot be confident about whether a change of 4 points represents a similarly significant change, but we will be mindful to assess this possibility. Ultimate aim is to determine whether disease-specific patient quality of life scores improve in investigational arm patients from baseline to successful completion of treatment.
  • 2. Changes in Short form 12 survey questionnaire (patient satisfaction and experience) from baseline to 12 months [ Time Frame: 12 months ]
    Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations). Ultimate aim is to determine whether disease-specific patient satisfaction scores improve in investigational arm patients from baseline to successful completion of treatment.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: Yes
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

Contacts and Locations
Contacts

Contact: Emma Douch +4402074046600 ext +4402074046600 emma.douch@london.msf.org

Locations

Belarus
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital
Minsk

South Africa, KwaZulu Natal
Doris Goodwin Hospital
Pietermaritzburg

South Africa, KwaZulu-Natal
Don McKenzie Hospital
Durban

Uzbekistan, Karakalpakstan
Republican TB Hospital No. 2
Nukus

Uzbekistan
Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital
Tashkent

Sponsors and Collaborators

Medecins Sans Frontieres, Netherlands

University of Sussex

London School of Hygiene and Tropical Medicine

Doris Goodwin Hospitals, Kwazulu Natal, South Africa

Don McKenzie Hospitals, Kwazulu Natal, South Africa

Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital

Republican specialised scientific-practical medical centre, Tashkent

Republican TB Hospital No. 2, Nukus

Investigators

Principal Investigator: Beverly Stringer MSF

More Information
  • Responsible Party: Medecins Sans Frontieres, Netherlands
  • ClinicalTrials.gov Identifier: NCT03942354 History of Changes
  • Other Study ID Numbers: PRACTECAL-PRO
  • First Posted: May 8, 2019 Key Record Dates
  • Last Update Posted: August 30, 2019
  • Last Verified: August 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Medecins Sans Frontieres, Netherlands: Quality of life, drug-resistant tuberculosis
  • Additional relevant MeSH terms: Tuberculosis Tuberculosis, Multidrug-Resistant