Multidrug Resistant TuberculosisPRACTECAL-PRONCT03942354
Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
An observational study of Multidrug Resistant Tuberculosis, run by Medecins Sans Frontieres, Netherlands at 6 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multidrug Resistant Tuberculosis
- What is being tested?
- Bedaquiline, Pretomanid and Moxifloxacin
- Type of treatment
- Injection or infusion
- How many people
- 137 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 1 Sep 2019to 10 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- TB patients excluded from TB-PRACTECAL clinical trial
- Healthy volenteers with co-morbidities
- Healthy volenteers found to have TB
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
South Africa3 sites
THINK Clinical Trial Unit, Hillcrest
Durban, KwaZulu-Natal, 3650
Helen Jospeh Hospital
Johannesburg
Doris Goodwin Hospital
Pietermaritzburg, KwaZulu-Natal
Uzbekistan2 sites
Republican TB Hospital No. 2
Nukus, Karakalpakstan
Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital
Tashkent
Belarus1 site
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital
Minsk
About this study
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.
Read the 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.
- Conditions
- Multidrug Resistant Tuberculosis
- Being tested
- Bedaquiline, Pretomanid, Moxifloxacin, Linezolid, Clofazimine
- Keywords
- Quality of life, drug-resistant tuberculosis
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BedaquilineDrug
Also called Sirturo, R207910, TMC207
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.
PretomanidDrug
Also called PA-824
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.
MoxifloxacinDrug
Also called Avelox, BAY 12-8039
Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria
LinezolidDrug
Also called Zyvox
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.
ClofazimineDrug
Also called Lamprene
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.
Directly observed therapy (DOT)Drug
Standard therapy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Directly observed therapy (DOT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start1 Sep 2019
- Primary completion10 May 2022
- Study completion10 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multidrug Resistant TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medecins Sans Frontieres, Netherlands
- Sponsor type
- University, hospital or other
- Collaborators
- 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
- Responsible party
- Sponsor
- Investigators
- Beverley Stringer, Principal investigator, MSF
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942354
- Sponsor's protocol ID
- PRACTECAL-PRO
- Acronym
- PRACTECAL-PRO
- Status last verified
- May 2024
- First submitted
- 22 Feb 2019
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34489263
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Experiences and Quality of Life Outcomes in the TB-PRACTECAL Clinical Trial
- ClinicalTrials.gov ID
- NCT03942354
- Acronym / sponsor ID
- PRACTECAL-PRO / PRACTECAL-PRO
- Conditions
- Multidrug Resistant Tuberculosis
- Keywords
- Quality of life, drug-resistant tuberculosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- Medecins Sans Frontieres, NetherlandsUniversity, hospital or other
- Collaborators
- 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
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 10 May 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 8 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | – | Drug: Bedaquiline, Drug: Pretomanid, Drug: Moxifloxacin, Drug: Linezolid, Drug: ClofazimineA 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. |
| Standard therapy | – | Drug: Directly observed therapy (DOT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- TB patients excluded from TB-PRACTECAL clinical trial
- Healthy volenteers with co-morbidities
- Healthy volenteers found to have TB
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BedaquilineAlso: Sirturo, R207910, TMC207Bedaquiline 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. | Drug | Intervention arm |
| PretomanidAlso: PA-824Pretomanid 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. | Drug | Intervention arm |
| MoxifloxacinAlso: Avelox, BAY 12-8039Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria | Drug | Intervention arm |
| LinezolidAlso: ZyvoxLinezolid, 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. | Drug | Intervention arm |
| ClofazimineAlso: LampreneClofazimine 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. | Drug | Intervention arm |
| Directly observed therapy (DOT)Standard therapy | Drug | Standard therapy |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 34489263Stringer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beverley Stringer principal investigator
MSF
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multidrug Resistant Tuberculosis, run by Medecins Sans Frontieres, Netherlands at 6 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in South Africa, Uzbekistan, Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in St George's respiratory questionnaire SGRQ survey questionnaire from baseline to 12 months (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03942354, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.