Clinical trial

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

Name

PRACTECAL-PRO

Description

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.

Trial arms

Trial start

2019-09-01

Estimated PCD

2022-05-10

Trial end

2022-05-10

Status

Completed

Treatment

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.

Arms:

Intervention arm

Other names:

Sirturo, R207910, TMC207

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.

Arms:

Intervention arm

Other names:

PA-824

Moxifloxacin

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

Arms:

Intervention arm

Other names:

Avelox, BAY 12-8039

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.

Arms:

Intervention arm

Other names:

Zyvox

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.

Arms:

Intervention arm

Other names:

Lamprene

Directly observed therapy (DOT)

Standard therapy

Arms:

Standard therapy

Size

137

Primary endpoint

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

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 137, 'type': 'ACTUAL'}}

Updated at

2024-05-29

1 organization

6 products

1 indication

Organization

Médecins Sans Frontières

Product

Bedaquiline

Indication

Multidrug-resistant tuberculosis

Product