Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
NCT ID: NCT03942354
Last Updated: 2024-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
137 participants
OBSERVATIONAL
2019-09-01
2022-05-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Intervention arm
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.
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.
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.
Moxifloxacin
Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria
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.
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.
Standard therapy
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.
Directly observed therapy (DOT)
Standard therapy
Interventions
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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.
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.
Moxifloxacin
Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria
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.
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.
Directly observed therapy (DOT)
Standard therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Healthy volenteers with co-morbidities
* Healthy volenteers found to have TB
18 Years
ALL
Yes
Sponsors
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University of Sussex
OTHER
London School of Hygiene and Tropical Medicine
OTHER
THINK TB & HIV Investigative Network
NETWORK
Wits Health Consortium (Pty) Ltd
OTHER
Ministry of Public Health, Republic of Belarus
OTHER_GOV
Ministry of Health, Republic of Uzbekistan
OTHER_GOV
Medecins Sans Frontieres, Netherlands
OTHER
Responsible Party
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Principal Investigators
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Beverley Stringer
Role: PRINCIPAL_INVESTIGATOR
MSF
Locations
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Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital
Minsk, , Belarus
THINK Clinical Trial Unit, Hillcrest
Durban, KwaZulu-Natal, South Africa
Doris Goodwin Hospital
Pietermaritzburg, KwaZulu-Natal, South Africa
Helen Jospeh Hospital
Johannesburg, , South Africa
Republican TB Hospital No. 2
Nukus, Karakalpakstan, Uzbekistan
Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital
Tashkent, , Uzbekistan
Countries
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References
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Stringer B, Lowton K, James N, Nyang'wa BT. Capturing patient-reported and quality of life outcomes with use of shorter regimens for drug-resistant tuberculosis: mixed-methods substudy protocol, TB PRACTECAL-PRO. BMJ Open. 2021 Sep 6;11(9):e043954. doi: 10.1136/bmjopen-2020-043954.
Other Identifiers
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PRACTECAL-PRO
Identifier Type: -
Identifier Source: org_study_id
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