Multi-drug Resistant TuberculosisTB-MRNCT03057756
Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
An observational study of Multi-drug Resistant Tuberculosis, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multi-drug Resistant Tuberculosis
- What is being tested?
- Km+ Mfx+ Pto + H + Cfz +E+Z
- How many people
- 23 participants
- Where
- 1 siteGabon
- Study dates
- 11 Sep 2015to 1 May 2023
- How long will I take part?
- 15 Months
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: study population will consist of all consecutive patients with bacteriologically proven MDR-TB who fulfil the inclusion criteria .
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Gabon1 site
Centre de Recherches Médicales de Lambaréné
Lambaréné, Please Select, BP 242
About this study
Official title: 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.
Read the 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.
- Conditions
- Multi-drug Resistant Tuberculosis
- Being tested
- Km+ Mfx+ Pto + H + Cfz +E+Z
- Keywords
- Multi-drug Resistant Tuberculosis, short course regimen protocol
- Medical subject headings
- Tuberculosis, Multidrug-Resistant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Km+ Mfx+ Pto + H + Cfz +E+ZCombination product
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide
| Study group | Role | What they receive |
|---|---|---|
| TB-MR patients | Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z Receives: Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z |
What is being measured
The primary outcome is the main question the study is designed to answer.
cure rate 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
Measured: Six months post treatment
Secondary outcomes (3)
TB-culture
First TB culture negative time
Measured: 4 months after start of the treatment
Regimen tolorability
treatment, safety through clinical and biological assessment
Measured: Throughout treatment period (9months)
Adverse events
solicited and unsolicited adverse events
Measured: duration of participant in the study (15months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start11 Sep 2015
- Primary completion4 Apr 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Multi-drug Resistant TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
- Target duration
- 15 Months
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Tropical Medicine, University of Tuebingen, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Responsible party
- Principal investigator, Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné
- Investigators
- Ayola A Adegnika, MD, PhD, Principal investigator, Centre de Recherches Médicales de Lambaréné
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057756
- Sponsor's protocol ID
- TB-MR 001/2015
- Acronym
- TB-MR
- Status last verified
- Mar 2026
- First submitted
- 13 Feb 2017
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eurosurveillance editorial team. WHO revised definitions and reporting framework for tuberculosis. Euro Surveill. 2013 Apr 18;18(16):20455. No abstract available.
PubMed 23611033Pablos-Mendez A, Raviglione MC, Laszlo A, Binkin N, Rieder HL, Bustreo F, Cohn DL, Lambregts-van Weezenbeek CS, Kim SJ, Chaulet P, Nunn P. Global surveillance for antituberculosis-drug resistance, 1994-1997. World Health Organization-International Union against Tuberculosis and Lung Disease Working Group on Anti-Tuberculosis Drug Resistance Surveillance. N Engl J Med. 1998 Jun 4;338(23):1641-9. doi: 10.1056/NEJM199806043382301.
PubMed 9614254Falzon D, Jaramillo E, Schunemann HJ, Arentz M, Bauer M, Bayona J, Blanc L, Caminero JA, Daley CL, Duncombe C, Fitzpatrick C, Gebhard A, Getahun H, Henkens M, Holtz TH, Keravec J, Keshavjee S, Khan AJ, Kulier R, Leimane V, Lienhardt C, Lu C, Mariandyshev A, Migliori GB, Mirzayev F, Mitnick CD, Nunn P, Nwagboniwe G, Oxlade O, Palmero D, Pavlinac P, Quelapio MI, Raviglione MC, Rich ML, Royce S, Rusch-Gerdes S, Salakaia A, Sarin R, Sculier D, Varaine F, Vitoria M, Walson JL, Wares F, Weyer K, White RA, Zignol M. WHO guidelines for the programmatic management of drug-resistant tuberculosis: 2011 update. Eur Respir J. 2011 Sep;38(3):516-28. doi: 10.1183/09031936.00073611. Epub 2011 Aug 4.
PubMed 21828024Stolp SM, Huson MA, Janssen S, Beyeme JO, Grobusch MP. Tuberculosis patients hospitalized in the Albert Schweitzer Hospital, Lambarene, Gabon-a retrospective observational study. Clin Microbiol Infect. 2013 Nov;19(11):E499-501. doi: 10.1111/1469-0691.12278. Epub 2013 Jul 4.
PubMed 23826878Van Deun A, Maug AK, Salim MA, Das PK, Sarker MR, Daru P, Rieder HL. Short, highly effective, and inexpensive standardized treatment of multidrug-resistant tuberculosis. Am J Respir Crit Care Med. 2010 Sep 1;182(5):684-92. doi: 10.1164/rccm.201001-0077OC. Epub 2010 May 4.
PubMed 20442432Laserson KF, Thorpe LE, Leimane V, Weyer K, Mitnick CD, Riekstina V, Zarovska E, Rich ML, Fraser HS, Alarcon E, Cegielski JP, Grzemska M, Gupta R, Espinal M. Speaking the same language: treatment outcome definitions for multidrug-resistant tuberculosis. Int J Tuberc Lung Dis. 2005 Jun;9(6):640-5.
PubMed 15971391Chiang CY, Caminero JA, Enarson DA. Reporting on multidrug-resistant tuberculosis: a proposed definition for the treatment outcome 'failed'. Int J Tuberc Lung Dis. 2009 May;13(5):548-50. No abstract available.
PubMed 19383184World Health Organization; International Union Against Tuberculosis and Lung Disease; Royal Netherlands Tuberculosis Association. Revised international definitions in tuberculosis control. Int J Tuberc Lung Dis. 2001 Mar;5(3):213-5. No abstract available.
PubMed 11326818