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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 : Not yet recruiting
First Posted : May 8, 2019
Last Update Posted : August 30, 2019
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
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.

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

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.

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Study Type : Interventional  (Clinical Trial)
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 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

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.
Other Names:
  • Sirturo
  • R207910
  • TMC207

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.
Other Name: PA-824

Drug: Moxifloxacin
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

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.
Other Name: Zyvox

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.
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)
Standard therapy




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.



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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

Information from the National Library of Medicine

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


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

Locations
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Belarus
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital Not yet recruiting
Minsk, Belarus
Contact: Animesh Sinha, MD    +375 297030902    minsk-ct-mtl@oca.msf.org   
Principal Investigator: Varvara Solodovnikova, MD         
South Africa
Doris Goodwin Hospital Not yet recruiting
Pietermaritzburg, KwaZulu Natal, South Africa
Contact: Ronelle Moodliar    0333980054    R.moodliar@thinksa.org.za   
Principal Investigator: Ronelle Moodliar, MBBS, MMed         
Don McKenzie Hospital Not yet recruiting
Durban, KwaZulu-Natal, South Africa
Contact: Ronelle Moodliar    033 3980054    R.moodliar@thinksa.org.za   
Principal Investigator: Ronelle Moodliar, MBBS,MMed         
Uzbekistan
Republican TB Hospital No. 2 Not yet recruiting
Nukus, Karakalpakstan, Uzbekistan
Contact: Misa Sha       NukusCT-crc@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
Tashkent, Uzbekistan
Contact: Mateus Sahani    +998 93 388 11 21    tashkent-crc-msf-oca <tashkent-crc@oca.msf.org>   
Principal Investigator: Irina Liverko, MD         
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
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Principal Investigator: Beverly Stringer MSF

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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

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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:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Moxifloxacin
Linezolid
Bedaquiline
Clofazimine
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Protein Synthesis Inhibitors
Antitubercular Agents
Anti-Inflammatory Agents
Leprostatic Agents