Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance

Multi-drug Resistant Tuberculosis Clinical Trial

— TB-MR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03057756
• Other study ID #: TB-MR 001/2015
• Status: Recruiting
• Start date: September 11, 2015
• Est. completion date: July 1, 2023

Study information

• Verified date: July 2021
• Source: Centre de Recherche Médicale de Lambaréné
• Contact: Ayola A Adegnika, MD, PhD
• Phone: +24107406464
• Email: aadegnika[@]cermel.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 23
• Est. completion date: July 1, 2023
• Est. primary completion date: April 4, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multi-drug Resistant Tuberculosis
• Tuberculosis
• Tuberculosis, Multidrug-Resistant

Intervention

Combination Product:
• Km+ Mfx+ Pto + H + Cfz +E+Z
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide

Locations

Country	Name	City	State
Gabon	Centre de Recherches Médicales de Lambaréné	Lambarene	Please Select

Sponsors (3)

Lead Sponsor	Collaborator
Centre de Recherche Médicale de Lambaréné	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Institute of Tropical Medicine, University of Tuebingen

Country where clinical trial is conducted

Gabon, 

References & Publications (8)

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. — View Citation

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

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 — View Citation

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. I — View Citation

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 a — View Citation

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: 10.1111/1469-0691.1227 — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six months post treatment
Secondary	TB-culture	First TB culture negative time	4 months after start of the treatment
Secondary	Regimen tolorability	treatment, safety through clinical and biological assessment	Throughout treatment period (9months)
Secondary	Adverse events	solicited and unsolicited adverse events	duration of participant in the study (15months)

External Links

•   web based information