Evaluation of Diabetes Control and Effect on Transmission... | NCT03498534

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

NCT03498534

Sponsor

Instituto Nacional de Salud Publica, Mexico

Status

Withdrawn

Last Update Posted

Apr 17, 2018Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Latent Tuberculosis
Diabetes Mellitus

Interventions

Isoniazid 300Mg Tab
Isoniazid 300 MG
Isoniazid 300 MG

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to administrative procedures

Expanded Access Info

Start Date

Sep 2012

Primary Completion Date

Dec 2012Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Mar 28, 2012

First Submission Date that Met QC Criteria

Apr 7, 2018

First Posted Date

Apr 13, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2018

Last Update Posted Date

Apr 17, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ma. de Lourdes Garcia Garcia, Director of the Center of Research in Infectious Diseases, Instituto Nacional de Salud Publica, MexicoPrincipal Investigator

Lead Sponsor

Instituto Nacional de Salud Publica, MexicoOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with a -TST	Active Comparator	In all patients with a negative TST test, Isoniazid 300 mg per day will be administered for 6 months	Drug: Isoniazid 300Mg Tab
Patients with a +TST	Active Comparator	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	Drug: Isoniazid 300 MG
HIV positive patients	Active Comparator	The researchers will test hepatic function and take a chest x-ray. Isoniazid 300 mg per day will be administered for 6 months	Drug: Isoniazid 300 MG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Isoniazid 300Mg Tab	Drug	-TST tests will receive isoniazid 300Mg Tab for 6 months	Patients with a -TST

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Development of active TB	Researchers will test patients at day 0 and day 180 of treatment to detect the development of active TB	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Positive HIV TST tuberculin

Exclusion Criteria:

Previous TB treatment Hepatic failure AIDS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Garcia-Garcia Lourdes, Doctor	National Institute of public Health	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055985	Latent Tuberculosis
D003920	Diabetes Mellitus
D000085343	Latent Infection
D014376	Tuberculosis

Ancestor Terms

ID	Term
D009164	Mycobacterium Infections
D000193	Actinomycetales Infections
D016908	Gram-Positive Bacterial Infections
D001424	Bacterial Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D007538	Isoniazid

Ancestor Terms

ID	Term
D006834	Hydrazines
D009930	Organic Chemicals
D007539	Isonicotinic Acids
D000147	Acids, Heterocyclic

Browse Leaves

Not provided

Browse Branches

Not provided