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Economic Evaluation of New MDR TB Regimens (PRACTECAL-EE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04207112
Recruitment Status : Not yet recruiting
First Posted : December 20, 2019
Last Update Posted : October 19, 2020
Sponsor:
Collaborators:
London School of Hygiene and Tropical Medicine
Ministry of Health, Republic of Uzbekistan
Ministry of Health, Belarus
TB & HIV Investigative Network (THINK)
Liverpool School of Tropical Medicine
Clinical HIV Reserach Unit, Wits Health Consortium
LSHTM Clinical Research Department
Information provided by (Responsible Party):
Medecins Sans Frontieres, Netherlands

Brief Summary:
The current treatment regimen for MDR-TB has poor outcomes and costs of treating MDR-TB are greater than treating drug susceptible TB, both in terms of health service and patient-incurred costs. Urgent action is needed to Identify short, effective and tolerable treatments for people with MDR-TB. The PRACTECAL economic evaluation sub-study (PRACTECAL-EE) will take place alongside the TB PRACTECAL trial, aiming to assess the costs to patients and providers of such regimens and to estimate the cost-effectiveness and poverty impact of an introduction of new MDR-TB regimens in the three countries participating in the main study.

Condition or disease Intervention/treatment Phase
Multi-drug Resistant Tuberculosis Extensively Drug-Resistant Tuberculosis Pulmonary Tuberculoses Drug: Bedaquiline Drug: Pretomanid Drug: Moxifloxacin Drug: Linezolid Drug: Clofazimine Drug: Standard Drugs Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Economic Evaluation of New MDR TB Regimens (PRACTECAL EE)
Estimated Study Start Date : October 20, 2020
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Bedaquiline

Arm Intervention/treatment
Experimental: Regimen 1: Bedaquiline, Pretomanid, Linezolid, Moxifloxacin
Bedaquiline: 400 mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks Pretomanid: 200mg once daily for 24 weeks Moxifloxacin: 400 mg once daily for 24 weeks Linezolid: 600mg daily for 16 weeks then 300mg daily (or 600mg x3/wk) for the remaining 8 weeks or earlier when moderately tolerated 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.
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 an 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 Names:
  • 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

Experimental: Regimen 2: Bedaquiline, Pretomanid, Linezolid, Clofazimine
Bedaquiline: 400 mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks Pretomanid: 200mg once daily for 24 weeks Linezolid: 600mg daily for 16 weeks then 300mg daily (or 600mg x3/wk) for the remaining 8 weeks or earlier when moderately tolerated Clofazimine: 50 mg (less than 33 kg), 100 mg (more than 33 kg) for 24 weeks
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 an 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: 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 (Cfz) 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

Experimental: Regimen 3: Bedaquiline, Pretomanid, Linezolid
Bedaquiline: 400 mg once daily for 2 weeks followed by 200 mg 3 times per week for 22 weeks Pretomanid: 200mg once daily for 24 weeks Linezolid: 600mg daily for 16 weeks then 300mg daily (or 600mg x3/wk) for the remaining 8 weeks or earlier when moderately tolerated)
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 an 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: 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

Active Comparator: Control regimen
Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB
Drug: Standard Drugs
Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.




Primary Outcome Measures :
  1. Incremental cost incurred per disability adjusted life year (DALY) averted: Societal Perspective [ Time Frame: 108 weeks post randomisation ]
    Incremental cost incurred per disability adjusted life year (DALY) averted with the intervention regimen compared to the standard of care from societal perspective. DALYs will be modelled up to a life time horizon using a markov model.

  2. Incremental cost per disability adjusted life year (DALY) averted: Provider Perspective [ Time Frame: 108 weeks post randomisation ]
    Incremental cost per disability adjusted life year (DALY) averted with the intervention regimen compared to the standard of care from provider perspective. DALYs will be modelled up to a life time horizon using a markov model.


Secondary Outcome Measures :
  1. Mean cost per month of treatment [ Time Frame: 108 weeks post randomisation ]
    Mean cost per month of treatment for different regimens and type of patient (MDR-TB, pre-XDR-TB (resistant to fluoroquinolone) and XDR-TB)

  2. Mean cost per course of treatment for different types of patients [ Time Frame: 108 weeks post randomisation ]
    Mean cost per course of treatment for different types of patients (MDR-TB, pre-XDR-TB (resistant to fluoroquinolone), XDR-TB) and by category (training, monitoring, service delivery and drugs)

  3. Incremental total cost of intervention for the trial population [ Time Frame: 108 weeks post randomisation ]
    Incremental total cost of intervention for the trial population, over the trial duration

  4. Incremental total cost of intervention for the modelling cohort [ Time Frame: 108 weeks post randomisation ]
    Incremental total cost of intervention for the modelling cohort, over a life time horizon



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adults with Mycobacterium tuberculosis resistant to at least rifampicin by either molecular or phenotypic drug susceptibility test.

Exclusion Criteria:

-


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): NCT04207112


Contacts
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Contact: Nicola James, MSc +44 (0) 207 0674 255 nicola.james@london.msf.org
Contact: Charlotte Batts Charlotte.Batts@london.msf.org

Locations
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Belarus
Republican Scientific and Practical Centre for Pulmonology and Tuberculosis hospital
Minsk, Belarus
Contact: Shahwar Kazmi, MD       minsk-ct-mtl@oca.msf.org   
Principal Investigator: Varvara Solodovnikova,, MD         
South Africa
Helen Joseph Hospital
Johannesburg, Gauteng, South Africa, 2092
Doris Goodwin Hospital
Pietermaritzburg, KwaZulu Natal, South Africa
Contact: Odette van Amsterdam    033 398 0054    O.Amsterdam@think.org.za   
Principal Investigator: Ronelle Moodliar, MBBS, MMed         
King DinuZulu Hospital
Durban, KwaZulu-Natal, South Africa, 4091
Contact: Londiwe Luthuli    +27 87 702 2581    lluthuli@witshealth.co.za   
Principal Investigator: Nosipho Ngubane, MBChB         
Don McKenzie Hospital
Durban, KwaZulu-Natal, South Africa
Contact: Seshni Moorgas    0317771009    s.moorgas@think.org.za   
Principal Investigator: Ronelle Moodliar, MBBS,MMed         
Uzbekistan
Republican TB Hospital No. 2
Nukus, Karakalpakstan, Uzbekistan
Contact: Gulayim Allanazarova       NukusCT-crc@oca.msf.org   
Principal Investigator: Tigay N Zinaida, MD         
Sh Alimov Republican Specialised Scientific-Practical Medical Centre for Phthysiology and Pulmonology Hospital
Tashkent, Uzbekistan
Contact: Kyi Pyar Min Htike       tashkent-crc@oca.msf.org   
Principal Investigator: Irina Liverko, MD         
Sponsors and Collaborators
Medecins Sans Frontieres, Netherlands
London School of Hygiene and Tropical Medicine
Ministry of Health, Republic of Uzbekistan
Ministry of Health, Belarus
TB & HIV Investigative Network (THINK)
Liverpool School of Tropical Medicine
Clinical HIV Reserach Unit, Wits Health Consortium
LSHTM Clinical Research Department
Investigators
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Principal Investigator: Sedona Sweeny London School of Hygiene and Tropical Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medecins Sans Frontieres, Netherlands
ClinicalTrials.gov Identifier: NCT04207112    
Other Study ID Numbers: PRACTECAL-EE
First Posted: December 20, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
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:
Bedaquiline
Pretomanid
Linezolid
Clofazimine
Moxifloxacin
Economic Evaluation
Pharmacoeconomics
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Pulmonary
Tuberculosis, Multidrug-Resistant
Extensively Drug-Resistant Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Moxifloxacin
Linezolid
Bedaquiline
Clofazimine
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Protein Synthesis Inhibitors
Antitubercular Agents
Anti-Inflammatory Agents
Leprostatic Agents