Novel Triple-dose Tuberculosis Retreatment Regimens: How to Overcome Resistance Without Creating More

NCT ID: NCT03862248

Last Updated: 2020-01-21

Study Results

Results pending

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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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-30

Study Completion Date

2022-10-01

Brief Summary

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Drug-resistance is a major challenge for tuberculosis (TB) care programs. The new WHO guideline recommends adding levofloxacin in previously treated patients with isoniazid-resistant rifampicin-susceptible TB. The investigators believe that such a retreatment regimen may result in acquired resistance to fluoroquinolone, the core drug of multidrug-resistant TB (MDR-TB) regimen, and thus threaten the effectiveness of the fluoroquinolone-based MDR-TB treatment regimen. Therefore the investigators propose to study if regimens strengthened by using high-dose first-line drugs, either a triple dose of isoniazid or a triple dose of rifampicin, are non-inferior to the WHO recommended levofloxacin-strengthened regimen. If one of both high-dose regimens would be non-inferior, it could replace the levofloxacin-strengthened regimen.

Detailed Description

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Conditions

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Tuberculosis, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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High-Dose Isoniazid

New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg

Group Type EXPERIMENTAL

6EH³RZ

Intervention Type DRUG

New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg

High-Dose Rifampicin

New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg

Group Type EXPERIMENTAL

6EHR³Z

Intervention Type DRUG

New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg

World Health Organisation (WHO) regimen

WHO levofloxacin-strengthened regimen (6EHRZLfx)

Group Type ACTIVE_COMPARATOR

6EHRZLfx

Intervention Type DRUG

WHO levofloxacin-strengthened regimen (6EHRZLfx)

Interventions

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6EH³RZ

New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg

Intervention Type DRUG

6EHR³Z

New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg

Intervention Type DRUG

6EHRZLfx

WHO levofloxacin-strengthened regimen (6EHRZLfx)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All newly registered patients with smear-positive recurrent pulmonary TB
* Adults as well as children (no age limit)
* Able and willing to provide written informed consent

Exclusion Criteria

* Patients transferred to a health facility not supported by Damien Foundation will be excluded. This includes patients diagnosed with HIV/TB-coinfection.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damien Foundation

OTHER

Sponsor Role collaborator

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Bangladesh

Other Identifiers

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TriDoRe

Identifier Type: -

Identifier Source: org_study_id

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