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| Name | Class |
|---|---|
| Institute of Tropical Medicine, University of Tuebingen | OTHER |
| Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TB-MR patients | Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Km+ Mfx+ Pto + H + Cfz +E+Z | Combination Product | Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| TB-culture | First TB culture negative time | 4 months after start of the treatment |
| Regimen tolorability | treatment, safety through clinical and biological assessment |
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Inclusion criteria:
Exclusion criteria:
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study population will consist of all consecutive patients with bacteriologically proven MDR-TB who fulfil the inclusion criteria .
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| Name | Affiliation | Role |
|---|---|---|
| Ayola A Adegnika, MD, PhD | Centre de Recherches Médicales de Lambaréné | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de Recherches Médicales de Lambaréné | Lambaréné | Please Select | BP 242 | Gabon |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23611033 | Result | Eurosurveillance editorial team. WHO revised definitions and reporting framework for tuberculosis. Euro Surveill. 2013 Apr 18;18(16):20455. No abstract available. | |
| 9614254 | Result | 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. |
| Label | URL |
|---|---|
| web based information | View source |
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| ID | Term |
|---|---|
| D018088 | Tuberculosis, Multidrug-Resistant |
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
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| ID | Term |
|---|---|
| D011522 | Protons |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 |
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| Throughout treatment period (9months) |
| Adverse events | solicited and unsolicited adverse events | duration of participant in the study (15months) |
| 21828024 | Result | 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. |
| 23826878 | Result | 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. |
| 20442432 | Result | 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. |
| 15971391 | Result | 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. |
| 19383184 | Result | 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. |
| 11326818 | Result | 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. |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |