Skip to main content
OpenTrials
Completed

NCT Number: NCT03057756

Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre de Recherches Médicales de Lambaréné

Lambaréné, Please Select, BP 242, Gabon

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Km+ Mfx+ Pto + H + Cfz +E+Z

Combination Product

Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide

Primary outcomes

  1. 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

Secondary outcomes

  1. TB-culture

    Time frame: 4 months after start of the treatment

    First TB culture negative time

  2. Regimen tolorability

    Time frame: Throughout treatment period (9months)

    treatment, safety through clinical and biological assessment

  3. Adverse events

    Time frame: duration of participant in the study (15months)

    solicited and unsolicited adverse events

Sponsors and collaborators

Lead sponsor

Centre de Recherche Médicale de Lambaréné

Other

Collaborators

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

Registry information

Official study title

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

Acronym: TB-MR

Important dates

Study start
2015
Primary completion
2023
Study completion
2023
First posted
Feb 20, 2017
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.