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Trial record 3 of 48 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

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.

Condition or disease Intervention/treatment
Multi-drug Resistant Tuberculosis Combination Product: Km+ Mfx+ Pto + H + Cfz +E+Z

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 23 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 15 Months
Official Title: Nine Months' Short Course Regimen Protocol for the Treatment of Multidrug Resistance-tuberculosis (MDR-TB) Patients in Gabon
Actual Study Start Date : September 11, 2015
Estimated Primary Completion Date : April 4, 2021
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Group/Cohort Intervention/treatment
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
Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. TB-culture [ Time Frame: 4 months after start of the treatment ]
    First TB culture negative time

  2. Regimen tolorability [ Time Frame: Throughout treatment period (9months) ]
    treatment, safety through clinical and biological assessment

  3. Adverse events [ Time Frame: duration of participant in the study (15months) ]
    solicited and unsolicited adverse events



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 .
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057756


Locations
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Gabon
Centre de Recherches Médicales de Lambaréné
Lambarene, Please Select, Gabon, BP 242
Sponsors and Collaborators
Centre de Recherche Médicale de Lambaréné
Institute of Tropical Medicine, University of Tuebingen
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Ayola A Adegnika, MD, PhD Centre de Recherches Médicales de Lambaréné

Additional Information:
Publications of Results:

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Responsible Party: Prof. Ayola Akim ADEGNIKA, Professor, Centre de Recherche Médicale de Lambaréné
ClinicalTrials.gov Identifier: NCT03057756     History of Changes
Other Study ID Numbers: TB-MR 001/2015
First Posted: February 20, 2017    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Ayola Akim ADEGNIKA, Centre de Recherche Médicale de Lambaréné:
Multi-drug Resistant Tuberculosis
short course regimen protocol
Additional relevant MeSH terms:
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Tuberculosis
Tuberculosis, Multidrug-Resistant
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections