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

NCT03942354 | Completed DMC

• 1 other identifier: PRACTECAL-PRO
• Study Type: observational
• Target: 137
• Locations: 3 countries
• Sites: 6

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.

Conditions

Multidrug Resistant Tuberculosis

Keywords

Quality of life, drug-resistant tuberculosis

Outcome Measures

Primary Outcomes (2)

• Change in St George's respiratory questionnaire SGRQ survey questionnaire from baseline to 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.

  12 months

• Changes in Short form 12 survey questionnaire (patient satisfaction and experience) from baseline to 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.

  12 months

Study Arms (2)

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.

Drug: Bedaquiline; Drug: Pretomanid; Drug: Moxifloxacin; Drug: Linezolid; Drug: Clofazimine

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.

Drug: Directly observed therapy (DOT)

Interventions

Bedaquiline DRUG

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.

Also known as: Sirturo, R207910, TMC207

Intervention arm

Pretomanid DRUG

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.

Also known as: PA-824

Intervention arm

Moxifloxacin DRUG

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

Also known as: Avelox, BAY 12-8039

Intervention arm

Linezolid DRUG

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.

Also known as: Zyvox

Intervention arm

Clofazimine DRUG

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.

Also known as: Lamprene

Intervention arm

Directly observed therapy (DOT) DRUG

Standard therapy

Standard therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This is an observational sub-study of parent RCT TB-PRACTECAL (NCT02589782. Arms 1 \& are the study population, and a sub-set of the main RCT cohort. Local healthy-controls of a similar profile in terms of age and gender aged ≥18 years are also included.

You may qualify if:

• 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.

You may not qualify if:

• TB patients excluded from TB-PRACTECAL clinical trial
• Healthy volenteers with co-morbidities
• Healthy volenteers found to have TB

Sponsors & Collaborators

• Medecins Sans Frontieres, Netherlands: lead
• University of Sussex: collaborator
• London School of Hygiene and Tropical Medicine: collaborator
• THINK TB & HIV Investigative Network: collaborator
• Wits Health Consortium (Pty) Ltd: collaborator
• Ministry of Public Health, Republic of Belarus: collaborator
• Ministry of Health, Republic of Uzbekistan: collaborator

Study Sites (6)

Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital

Minsk, Belarus

Location

THINK Clinical Trial Unit, Hillcrest

Durban, KwaZulu-Natal, 3650, South Africa

Location

Doris Goodwin Hospital

Pietermaritzburg, KwaZulu-Natal, South Africa

Location

Helen Jospeh Hospital

Johannesburg, South Africa

Location

Republican TB Hospital No. 2

Nukus, Karakalpakstan, Uzbekistan

Location

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

Tashkent, Uzbekistan

Location

Related Publications (1)

• 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.

  PMID: 34489263 DERIVED

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Interventions

bedaquiline; pretomanid; Moxifloxacin; Linezolid; Clofazimine

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Oxazolidinones; Oxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Phenazines; Heterocyclic Compounds, 3-Ring

Study Officials

• Beverley Stringer

  MSF

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2019
• First Posted: May 8, 2019
• Study Start: September 1, 2019
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: May 29, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (3); BE (1); UZ (2)