Clinical trial NCT03057756: Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance
Official title: Nine Months' Short Course Regimen Protocol for the Treatment of Multidrug Resistance-tuberculosis (MDR-TB) Patients in Gabon
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multi-drug Resistant Tuberculosis
Keywords: Multi-drug Resistant Tuberculosis
short course regimen protocol
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
Collaborators: name: Institute of Tropical Medicine, University of Tuebingen
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
First posted: 2017-02-20
Enrollment: 23
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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 .

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.

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.

Eligibility 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.

Primary outcomes:
measure: cure rate post treatment
timeFrame: Six months post treatment
Secondary outcomes:
measure: TB-culture
timeFrame: 4 months after start of the treatment
measure: Regimen tolorability
timeFrame: Throughout treatment period (9months)
measure: Adverse events
timeFrame: duration of participant in the study (15months)
Other outcomes:
Locations:
city: Lambarene
country: Gabon
facility: Centre de Recherches Médicales de Lambaréné
state: Please Select
Study officials:
affiliation: Centre de Recherches Médicales de Lambaréné
name: Ayola A Adegnika, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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. Epub 2010 May 4.
citation: 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.
citation: 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.
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. No abstract available.