Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More
NCT ID: NCT03862248
Last Updated: 2020-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2019-09-30
2022-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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High-Dose Isoniazid
New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg
6EH³RZ
New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg
High-Dose Rifampicin
New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg
6EHR³Z
New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg
World Health Organisation (WHO) regimen
WHO levofloxacin-strengthened regimen (6EHRZLfx)
6EHRZLfx
WHO levofloxacin-strengthened regimen (6EHRZLfx)
Interventions
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6EH³RZ
New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg
6EHR³Z
New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg
6EHRZLfx
WHO levofloxacin-strengthened regimen (6EHRZLfx)
Eligibility Criteria
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Inclusion Criteria
* Adults as well as children (no age limit)
* Able and willing to provide written informed consent
Exclusion Criteria
ALL
No
Sponsors
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Damien Foundation
OTHER
Institute of Tropical Medicine, Belgium
OTHER
Responsible Party
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Principal Investigators
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Tom Decroo, MD
Role: PRINCIPAL_INVESTIGATOR
Insitute of Tropical Medicine Antwerp
Locations
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Damien Foundation
Dhaka, , Bangladesh
Countries
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Other Identifiers
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TriDoRe
Identifier Type: -
Identifier Source: org_study_id
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