MedTrace Logo

Rifampicin at High Dose for Difficult-to-Treat Tuberculosis

NCT04768231 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2021-02-24

No results posted yet for this study

Summary

The purpose of this study is to assess the safety of rifampicin given at a dose three times as the standard one, in persons with tuberculosis that belong to groups that have not been widely included in previous trials.

Conditions

Interventions

DRUG

Rifampin

The target dose of 35mg/kg will be reached supplementing fixed-dose combination tablets (standard dose) with rifampin-only tablets.

Sponsors & Collaborators

  • University Medical Center Groningen

    collaborator OTHER

  • Radboud University Medical Center

    collaborator OTHER

  • Centro Hospitalar De São João, E.P.E.

    collaborator OTHER

  • Instituto Nacional de Enfermedades Respiratorias y del Ambiente, Paraguay

    collaborator UNKNOWN

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Adrián Sánchez-Montalvá, PhD · Vall d'Hebron University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-01
Primary Completion
2022-12-31
Completion
2023-12-31

Countries

  • Netherlands
  • Paraguay
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04768231 on ClinicalTrials.gov