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

• ClinicalTrials.gov Identifier: NCT03057756
• Recruitment Status: Active, not recruiting
• First Posted: February 20, 2017
• Last Update Posted: July 23, 2019
• Sponsor: Centre de Recherche Médicale de Lambaréné
• Collaborators: Institute of Tropical Medicine, University of Tuebingen; Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Information provided by (Responsible Party): Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné

Study Description

Brief 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.

Condition or disease	Intervention/treatment
Multi-drug Resistant Tuberculosis	Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z

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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 23 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Target Follow-Up Duration: 15 Months
• Official Title: Nine Months' Short Course Regimen Protocol for the Treatment of Multidrug Resistance-tuberculosis (MDR-TB) Patients in Gabon
• Actual Study Start Date: September 11, 2015
• Estimated Primary Completion Date: April 4, 2021
• Estimated Study Completion Date: July 1, 2022

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 15 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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 .

Criteria

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.

Contacts and Locations

Locations

Gabon

Centre de Recherches Médicales de Lambaréné

Lambarene, Please Select, Gabon, BP 242

Sponsors and Collaborators

Centre de Recherche Médicale de Lambaréné

Institute of Tropical Medicine, University of Tuebingen

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigators

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

More Information

Additional Information:

web based information 

Publications of Results:

Eurosurveillance editorial team. WHO revised definitions and reporting framework for tuberculosis. Euro Surveill. 2013 Apr 18;18(16):20455.

Pablos-Méndez 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. Erratum in: N England J Med 1998 Jul 9;339(2):139.

Falzon D, Jaramillo E, Schünemann 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, Rüsch-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.

Stolp SM, Huson MA, Janssen S, Beyeme JO, Grobusch MP. Tuberculosis patients hospitalized in the Albert Schweitzer Hospital, Lambaréné, Gabon-a retrospective observational study. Clin Microbiol Infect. 2013 Nov;19(11):E499-501. doi: 10.1111/1469-0691.12278. Epub 2013 Jul 4.

Van 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.

Laserson KF, Thorpe LE, Leimane V, Weyer K, Mitnick CD, Riekstina V, Zarovska E, Rich ML, Fraser HS, Alarcón 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.

Chiang 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. Review.

World 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.

• Responsible Party: Prof. Ayola Akim ADEGNIKA, Professor, Centre de Recherche Médicale de Lambaréné
• ClinicalTrials.gov Identifier: NCT03057756 History of Changes
• Other Study ID Numbers: TB-MR 001/2015
• First Posted: February 20, 2017
• Last Update Posted: July 23, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné:

Multi-drug Resistant Tuberculosis; short course regimen protocol

Additional relevant MeSH terms:

Tuberculosis; Tuberculosis, Multidrug-Resistant; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections