Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial (PRACTECAL-PRO)
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|ClinicalTrials.gov Identifier: NCT03942354|
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : October 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Multidrug Resistant Tuberculosis||Drug: Bedaquiline Drug: Pretomanid Drug: Moxifloxacin Drug: Linezolid Drug: Clofazimine Drug: Directly observed therapy (DOT)||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||July 31, 2022|
|Estimated Study Completion Date :||July 31, 2022|
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.
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 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.
Other Name: PA-824
Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria
Other Name: Avelox, BAY 12-8039
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.
Other Name: Zyvox
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.
Other Name: Lamprene
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)
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03942354
|Contact: Nicola James, MSc||+44 firstname.lastname@example.org|
|Contact: Charlotte Batts|
|Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital||Recruiting|
|Contact: Shahwar Kazmi email@example.com|
|Principal Investigator: Varvara Solodovnikova, MD|
|Doris Goodwin Hospital||Recruiting|
|Pietermaritzburg, KwaZulu Natal, South Africa|
|Contact: Odette van Amsterdam 033 398 0054 O.Amsterdam@thinksa.org.za|
|Principal Investigator: Ronelle Moodliar, MBBS, MMed|
|Don McKenzie Hospital||Recruiting|
|Durban, KwaZulu-Natal, South Africa|
|Contact: Seshni Moorgas 0317771009 firstname.lastname@example.org|
|Principal Investigator: Ronelle Moodliar, MBBS,MMed|
|Helen Jospeh Hospital||Not yet recruiting|
|Johannesburg, South Africa|
|Contact: Sharon Motlhako +27 11 276 8800 email@example.com|
|Principal Investigator: Mohammed Rassool, MBChB|
|Republican TB Hospital No. 2||Recruiting|
|Nukus, Karakalpakstan, Uzbekistan|
|Contact: Gulayim Allanazarova NukusCT-CTC@oca.msf.org|
|Principal Investigator: Tigay N Zinaida, MD|
|Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital||Not yet recruiting|
|Contact: Kyi Pyar Min Htike firstname.lastname@example.org|
|Principal Investigator: Irina Liverko, MD|
|Principal Investigator:||Beverley Stringer||MSF|