Multi-drug Resistant Tuberculosis Clinical Trial
— TB-MROfficial 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.
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. |
Country | Name | City | State |
---|---|---|---|
Gabon | Centre de Recherches Médicales de Lambaréné | Lambarene | Please Select |
Lead Sponsor | Collaborator |
---|---|
Centre de Recherche Médicale de Lambaréné | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Institute of Tropical Medicine, University of Tuebingen |
Gabon,
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
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) |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04207112 -
Economic Evaluation of New MDR TB Regimens
|
Phase 2/Phase 3 | |
Completed |
NCT03000517 -
PK of Levofloxacin in MDR-TB Patients
|
N/A | |
Completed |
NCT03470233 -
Post Marketing Registry to Assess Usage, Safety and Effectiveness of Deltyba Tablets in Korean Patients With MDR-TB
|
||
Completed |
NCT03830671 -
The Effect of 18-month Regimen Containing 6 Anti-tuberculosis Drugs for Patients With MDR-TB
|
Phase 4 | |
Withdrawn |
NCT01600963 -
A Study to Evaluate the Efficacy and Safety of TMC207 in Patients With Pulmonary Infection With Multi-drug Resistant Mycobacterium Tuberculosis
|
Phase 3 | |
Recruiting |
NCT03575299 -
Clinical Study on Adoptive Treatment of MDR-TB With Allogeneic γδT Cells
|
Phase 1 | |
Recruiting |
NCT03827811 -
Pharmacometrics to Advance Novel Regimens for Drug-resistant Tuberculosis-PandrTB Tuberculosis
|
||
Completed |
NCT04342598 -
Case Control Study of Vitamin D Status and Adult Multidrug-resistant Pulmonary Tuberculosis in Maharashtra, India
|
||
Completed |
NCT04309656 -
A Study in Two Panels of Healthy Adult Participants to Assess Single-Dose Immediate-Release and Single-Dose Dispersible Formulations of Pretomanid
|
Phase 1 | |
Completed |
NCT03822156 -
Clinical Analysis of the Patients With Cavitary Pulmonary TB and Endobronchial TB in the PPM-UUH Cohort
|
||
Completed |
NCT00425113 -
Metronidazole for Pulmonary Tuberculosis (South Korea)
|
Phase 2 | |
Active, not recruiting |
NCT04081077 -
PRACTECAL-PKPD Sub Study
|
Phase 2/Phase 3 | |
Recruiting |
NCT04397536 -
New Genomic Techniques and Management of Multidrug-resistant Tuberculosis
|
||
Completed |
NCT00691392 -
Linezolid Pharmacokinetics (PK) in Multi-Drug Resistant (MDR)/Extensively-Drug Resistant (XDR) Tuberculosis (TB)
|
Phase 1/Phase 2 | |
Completed |
NCT00664313 -
TBTC Study 30: Safety and Tolerability of Low Dose Linezolid in MDR TB
|
Phase 1/Phase 2 |