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Trial record 6 of 51 for:    ( Map: Gabon )

Treatment of Tuberculosis Multidrug Resistance Treatment of Tuberculosis Multidrug Resistance (TB-MR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03057756
Recruitment Status : Active, not recruiting
First Posted : February 20, 2017
Last Update Posted : July 23, 2019
Sponsor:
Collaborators:
Institute of Tropical Medicine, University of Tuebingen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Information provided by (Responsible Party):
Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné

Tracking Information
First Submitted Date February 13, 2017
First Posted Date February 20, 2017
Last Update Posted Date July 23, 2019
Actual Study Start Date September 11, 2015
Estimated Primary Completion Date April 4, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 15, 2017)
cure rate post treatment [ Time Frame: Six months 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 15, 2017)
  • TB-culture [ Time Frame: 4 months after start of the treatment ]
    First TB culture negative time
  • Regimen tolorability [ Time Frame: Throughout treatment period (9months) ]
    treatment, safety through clinical and biological assessment
  • Adverse events [ Time Frame: duration of participant in the study (15months) ]
    solicited and unsolicited adverse events
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 15 Months
Biospecimen Not Provided
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 .
Condition Multi-drug Resistant Tuberculosis
Intervention Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide
Study Groups/Cohorts TB-MR patients
Patients older than 15 years old receiving Km+ Mfx+ Pto + H + Cfz +E+Z
Intervention: Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: January 29, 2019)
23
Original Estimated Enrollment
 (submitted: February 15, 2017)
30
Estimated Study Completion Date July 1, 2022
Estimated Primary Completion Date April 4, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Gabon
Removed Location Countries  
 
Administrative Information
NCT Number NCT03057756
Other Study ID Numbers TB-MR 001/2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné
Study Sponsor Centre de Recherche Médicale de Lambaréné
Collaborators
  • Institute of Tropical Medicine, University of Tuebingen
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Principal Investigator: Ayola A Adegnika, MD, PhD Centre de Recherches Médicales de Lambaréné
PRS Account Centre de Recherche Médicale de Lambaréné
Verification Date July 2019