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

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

Sponsors

Lead Sponsor: Medecins Sans Frontieres, Netherlands

Collaborator: University of Sussex
London School of Hygiene and Tropical Medicine
THINK TB & HIV Investigative Network
Wits Health Consortium (Pty) Ltd
Ministry of Public Health, Republic of Belarus
Ministry of Health, Republic of Uzbekistan

Source Medecins Sans Frontieres, Netherlands
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.

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.

Overall Status Recruiting
Start Date 2019-09-01
Completion Date 2022-10-31
Primary Completion Date 2022-09-30
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in St George's respiratory questionnaire SGRQ survey questionnaire from baseline to 12 months 12 months
Changes in Short form 12 survey questionnaire (patient satisfaction and experience) from baseline to 12 months 12 months
Enrollment 54
Condition
Intervention

Intervention Type: Drug

Intervention Name: Bedaquiline

Description: 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.

Arm Group Label: Intervention arm

Intervention Type: Drug

Intervention Name: Pretomanid

Description: 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.

Arm Group Label: Intervention arm

Other Name: PA-824

Intervention Type: Drug

Intervention Name: Moxifloxacin

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

Arm Group Label: Intervention arm

Other Name: Avelox, BAY 12-8039

Intervention Type: Drug

Intervention Name: Linezolid

Description: 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.

Arm Group Label: Intervention arm

Other Name: Zyvox

Intervention Type: Drug

Intervention Name: Clofazimine

Description: 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.

Arm Group Label: Intervention arm

Other Name: Lamprene

Intervention Type: Drug

Intervention Name: Directly observed therapy (DOT)

Description: Standard therapy

Arm Group Label: Standard therapy

Eligibility

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Beverley Stringer Principal Investigator MSF
Overall Contact

Last Name: Nicola James, MSc

Phone: +44 2070674255

Email: [email protected]

Location
Facility: Status: Contact: Investigator:
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital | Minsk, Belarus Recruiting Ernest Nshimiyimana, MD +375336486008 [email protected] Varvara Solodovnikova, MD Principal Investigator
Doris Goodwin Hospital | Pietermaritzburg, KwaZulu Natal, South Africa Recruiting Odette van Amsterdam 033 398 0054 [email protected] Ronelle Moodliar, MBBS, MMed Principal Investigator
THINK Clinical Trial Unit, Hillcrest | Durban, KwaZulu-Natal, 3650, South Africa Recruiting Seshni Moorgas 0317771009 [email protected] Ronelle Moodliar, MBBS,MMed Principal Investigator
Helen Jospeh Hospital | Johannesburg, South Africa Recruiting Sharon Motlhako +27 11 276 8800 [email protected] Mohammed Rassool, MBChB Principal Investigator
Republican TB Hospital No. 2 | Nukus, Karakalpakstan, Uzbekistan Recruiting Soe Moe, MD +998939200344 [email protected] Tigay N Zinaida, MD Principal Investigator
Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital | Tashkent, Uzbekistan Recruiting Pei Sun Aw, MD +998 933881121 [email protected] Irina Liverko, MD Principal Investigator
Location Countries

Belarus

South Africa

Uzbekistan

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Intervention arm

Type: Experimental

Description: A total of 72 intervention arm trial patients (from TB-PRACTECAL trial) are anticipated across all three sites: South Africa, Belarus, and Karakalpakstan.

Label: Standard therapy

Type: Active Comparator

Description: 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.

Acronym PRACTECAL-PRO
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

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