Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance (TB-MR)

March 16, 2026 updated by: Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné

Nine Months' Short Course Regimen Protocol for the Treatment of Multidrug Resistance-tuberculosis (MDR-TB) Patients in Gabon

The principal objective is to evaluate a cure rate and number of adverse events of with confirmed multidrug-resistant tuberculosis patient treated with a 9months regimen.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study participants will be followed up, under existing protocol derived from a study protocol developed by the "Union internationale contre les maladies respiratoires" and carried out already in 9 Africans countries. Participants will be hospitalised for at least four month, period which they will be given treatments, assessed for adverse events, monitored for TB-MR strains using culture techniques, at the monthly basis. If patients found with negative sputum culture at month four they will be dischrged from the hospital, and then treated four an additional five montns and then follow up, clinically and biologically for an additional six months before being declared as cured.

Study Type

Observational

Enrollment (Actual)

23

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Gabon
    • Please Select
      • Lambaréné, Please Select, Gabon, BP 242
        • Centre de Recherches Médicales de Lambaréné

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

study population will consist of all consecutive patients with bacteriologically proven MDR-TB who fulfil the inclusion criteria .

Description

Inclusion criteria:

  • Aged 15 years and above
  • Never been treated with second line anti-TB drugs for more than one month,
  • Give written consent to participate
  • Agree to be hospitalised for at least four months in specialised healthcare
  • Willing to adhere to ambulatory directly observed treatment by a healthcare worker;

Exclusion criteria:

  • Pregnant during inclusion process
  • Presented with altered clinical status condition as judged by the clinician
  • Knowing of history of hypersensitivity reaction to any of the drugs to be used
  • Baseline ECG does not show a QT space superior to 500ms
  • Refusal to participate into study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TB-MR patients
Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z
Combination product: Km+ Mfx+ Pto + H + Cfz +E+Z
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
cure rate post treatment
Time Frame: Six months post treatment
Proportion of participants alive and presented with negative sputum culture for TB and with the absence of clinical, X-Ray and biological disorders related to TB
Six months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
TB-culture
Time Frame: 4 months after start of the treatment
First TB culture negative time
4 months after start of the treatment
Regimen tolorability
Time Frame: Throughout treatment period (9months)
treatment, safety through clinical and biological assessment
Throughout treatment period (9months)
Adverse events
Time Frame: duration of participant in the study (15months)
solicited and unsolicited adverse events
duration of participant in the study (15months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre de Recherche Médicale de Lambaréné

Collaborators

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Institute of Tropical Medicine, University of Tuebingen

Investigators

  • Principal Investigator: Ayola A Adegnika, MD, PhD, Centre de Recherches Médicales de Lambaréné

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2015

Primary Completion (Actual)

April 4, 2023

Study Completion (Actual)

May 1, 2023

Study Registration Dates

First Submitted

February 13, 2017

First Submitted That Met QC Criteria

February 15, 2017

First Posted (Actual)

February 20, 2017

Study Record Updates

Last Update Posted (Actual)

March 17, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TB-MR 001/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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