NCT03057756

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2015

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 20, 2017

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

7.6 years

First QC Date

February 13, 2017

Last Update Submit

March 16, 2026

Conditions

Multi-drug Resistant Tuberculosis

Keywords

Multi-drug Resistant Tuberculosisshort course regimen protocol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • TB-culture

    4 months after start of the treatment

  • Regimen tolorability

    Throughout treatment period (9months)

  • Adverse events

    duration of participant in the study (15months)

Study Arms (1)

TB-MR patients

Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z

Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z

Interventions

Km+ Mfx+ Pto + H + Cfz +E+ZCOMBINATION_PRODUCT

Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide

TB-MR patients

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

study population will consist of all consecutive patients with bacteriologically proven MDR-TB who fulfil the inclusion criteria .

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherches Médicales de Lambaréné

Lambaréné, Please Select, BP 242, Gabon

Location

Related Publications (8)

  • Eurosurveillance editorial team. WHO revised definitions and reporting framework for tuberculosis. Euro Surveill. 2013 Apr 18;18(16):20455. No abstract available.

    PMID: 23611033RESULT

  • 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.

    PMID: 9614254RESULT

  • 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.

    PMID: 21828024RESULT

  • 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.

    PMID: 23826878RESULT

  • 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.

    PMID: 20442432RESULT

  • 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.

    PMID: 15971391RESULT

  • 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.

    PMID: 19383184RESULT

  • 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.

    PMID: 11326818RESULT

Related Links

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Interventions

Protons

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Cations, MonovalentCationsIonsElectrolytesInorganic ChemicalsHydrogenElementsGasesNucleonsElementary ParticlesPhysical Phenomena

Study Officials

  • Ayola A Adegnika, MD, PhD

    Centre de Recherches Médicales de Lambaréné

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
15 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 20, 2017

Study Start

September 11, 2015

Primary Completion

April 4, 2023

Study Completion

May 1, 2023

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

GA(1)