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Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis

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: NCT03498534
Recruitment Status : Withdrawn (Due to administrative procedures)
First Posted : April 13, 2018
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico

Tracking Information
First Submitted Date  ICMJE March 28, 2012
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date April 18, 2018
Study Start Date  ICMJE September 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 7, 2018)
Development of active TB [ Time Frame: 6 months ]
Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Diabetes Control and Effect on Transmission and Development of Tuberculosis
Official Title  ICMJE Evaluation of the Impact of Diabetes Control on Transmission and Development of Tuberculosis in the General Population
Brief Summary

Clinical test (essay) randomized to evaluate the toxicity adherence and efficiency of the chemoprophylaxis of tuberculosis (TB) in subjects with Diabetes Mellitus (DM) and latent TB. (600 subjects followed(continued) by 15 months). 3rd stage. Patients with DM and TB will be included to determine if the strict control of the dm achieved in clinics of the first level of attention improves clinical manifestations of tb, the result of treatment, the frequency of relapses, the mortality and the transmission to contacts.

Elispot will be used to measure TB development and the time for the bacteriological negativization and biochemical parameters as well as tuberculin skin test (TST), quantiferon, in contacts. (160 patients 600 contacts followed(continued) for 12 months). additional there will be evaluated the socioeconomic impact of both diseases and his(her) control. 1er year: transverse study and recruitment years 2 and 3 participants' follow-ups in clinical tests(essays).

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Latent Tuberculosis
  • Diabetes Mellitus
Intervention  ICMJE
  • Drug: Isoniazid 300Mg Tab
    -TST tests will receive isoniazid 300Mg Tab for 6 months
    Other Name: Isoniazid 300 mgs.
  • Drug: Isoniazid 300 MG
    + TST test will receive isoniazid 300MG Tab for 6 months
    Other Name: Isoniazid
  • Drug: Isoniazid 300 MG
    HIV positive patient will receive isoniazid 300MGTab for 6 months
    Other Name: Isoniazid 300 mg per day
Study Arms  ICMJE
  • Active Comparator: Patients with a -TST
    In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months
    Intervention: Drug: Isoniazid 300Mg Tab
  • Active Comparator: Patients with a +TST
    In patients with a +TST test researchers will test for HIV, hepatic function and we will take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months
    Intervention: Drug: Isoniazid 300 MG
  • Active Comparator: HIV positive patients
    The researchers will test hepatic function and take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months
    Intervention: Drug: Isoniazid 300 MG
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 7, 2018)
0
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Positive HIV TST tuberculin

Exclusion Criteria:

  • Previous TB treatment Hepatic failure AIDS
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03498534
Other Study ID Numbers  ICMJE CI-543
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico
Study Sponsor  ICMJE Instituto Nacional de Salud Publica, Mexico
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Garcia-Garcia Lourdes, Doctor National Institute of public Health
PRS Account Instituto Nacional de Salud Publica, Mexico
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP