Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
NCT ID: NCT03057756
Last Updated: 2021-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
23 participants
OBSERVATIONAL
2015-09-11
2023-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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TB-MR patients
Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z
Km+ Mfx+ Pto + H + Cfz +E+Z
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide
Interventions
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Km+ Mfx+ Pto + H + Cfz +E+Z
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
15 Years
ALL
Yes
Sponsors
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Institute of Tropical Medicine, University of Tuebingen
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Centre de Recherche Médicale de Lambaréné
OTHER
Responsible Party
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Prof. Ayola Akim ADEGNIKA
Professor
Principal Investigators
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Ayola A Adegnika, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre de Recherches Médicales de Lambaréné
Locations
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Centre de Recherches Médicales de Lambaréné
Lambaréné, Please Select, Gabon
Countries
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Central Contacts
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Facility Contacts
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References
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Eurosurveillance editorial team. WHO revised definitions and reporting framework for tuberculosis. Euro Surveill. 2013 Apr 18;18(16):20455. No abstract available.
Pablos-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.
Falzon 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.
Stolp 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.
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, 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.
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. No abstract available.
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. No abstract available.
Related Links
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web based information
Other Identifiers
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TB-MR 001/2015
Identifier Type: -
Identifier Source: org_study_id
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