ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy, Security, Adherence, Tolerability and Cost Effectiveness of Latent TB Treatment in Patients With TB/DM2 (TBL) (TBL)

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: NCT03278483
Recruitment Status : Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
Sponsor:
Collaborators:
Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Ciencias Medicas y Nutrición
Information provided by (Responsible Party):
Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico

Brief Summary:

Researchers will evaluate the efficacy, toxicity, adherence and cost effectiveness of treatment with isoniazid or rifampicin in patients with diabetes mellitus type two (DM2) and latent TB (LTB).

This is a collaborative study with participation from three national institutes (Instituto Nacional de Salud Pública (INSP), Instituto Nacional de Enfermedades Respiratorias (INER) and the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubiran (INCMNSZ)).

The study will take place in the VII sanitary jurisdiction of Orizaba and the INCMNSZ that has the necessary infrastructure and human resources. Researchers will evaluate 3000 patients with diabetes using a standardized questionnaire and a tuberculin skin test (TST) test. Eligible patients will be invited to participate and from those that agree to participate and sign a written informed consent we will obtain clinical, epidemiological, nutritional and metabolic information. Patients with altered liver function tests will be excluded.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Tuberculin (Skin Test) Positive Drug: Isoniazid 300 mg Oral Tablet Drug: Rifampin 600 mg Oral Tablet Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • Arm Isoniacid Diabetic patients with a positive TST of >10mm, who wil be randomly assigned to receive treatment with isoniazid tablets 300mg daily plus pyridoxine 50mg daily
  • Arm B Diabetic patients with a positive TST of >10mm, who wil be randomly assigned to receive treatment with rifampin capsules 600mg daily
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy, Security, Adherence, Tolerability and Cost Effectiveness of Latent TB Treatment in Patients With TB/DM2
Actual Study Start Date : July 10, 2017
Estimated Primary Completion Date : December 16, 2018
Estimated Study Completion Date : July 15, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Isoniazid
Diabetic patients with a positive TST of >10mm, will be randomly assigned to receive treatment with isoniazid 300mg Oral Tablet daily plus pyridoxine 50mg daily for six months
Drug: Isoniazid 300 mg Oral Tablet
Isoniazid tablets 300mg daily plus pyridoxine 50mg daily
Other Name: Isonicotinic acid
Active Comparator: Rifampin
Diabetic patients with a positive TST of >10mm, who wil be randomly assigned to receive treatment with rifampin 600mg Oral Tablets daily for three months
Drug: Rifampin 600 mg Oral Tablet
Rifampin capsules 600mg daily
Other Name: Rifadin



Primary Outcome Measures :
  1. Efficacy of treatment with rifampicin compared to efficacy of treatment with isoniazid [ Time Frame: Up to 18 months ]
    Researchers will measure with ELISA in vitro production of interferon gamma of peripheric mononuclear cels as a response to stimuli by RV0849 and RV1737 antigens. The cut of value is of >100pg/ml.

  2. Toxicity (neuropathy) [ Time Frame: Up to 6 months ]
    Neurological alterations will be assessed using the Michigan questionnaire and in a subsample they will evaluate neuropathy using electroneurography.

  3. Adherence [ Time Frame: Up to 6 months ]
    Counting the number of administered pills, adequate adherence is more than 80% of administered pills.

  4. Toxicity (liver function) [ Time Frame: Up to 6 months ]
    Liver function tests



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes mellitus (DM2) diagnosed based on the National Official Norm
  2. respiratory symptoms
  3. Tuberculin Skin Test (TST) >10mm of induration
  4. chest X ray without pleural, lung or mediastinal lesions
  5. hemoglobin < 8 gm/dl
  6. platelets > 60,000 per microliter
  7. bilirubin < 2.5 mg/dl
  8. Aspartate aminotransferase (AST) , Glutamic oxalacetic transaminases (SGOT) and alkaline phosphatase less than twice the normal value
  9. negative pregnancy test
  10. negative Human immunodeficiency virus infection test (HIV test)
  11. signed written informed consent.

Exclusion Criteria:

  1. Attending selected cites
  2. Respiratory symptoms defined as cough with or without sputum for more than 2 weeks
  3. Evidence or clinical suspicion of active tuberculosis (TB)
  4. Current treatment with antituberculous drugs
  5. History of having received more than one month's treatment for latent Tuberculosis (LTB) or antituberculous drugs
  6. Hypersensitivity or intolerance to isoniazid or rifampicin
  7. Active hepatopathy
  8. Grade III or higher peripheral neuropathy
  9. Chronic alcohol ingestion
  10. Contacts of patients with isoniazid or rifampicin drug resistance

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): NCT03278483


Locations
Mexico
Instituto Nacional de Ciencias Medicas y Nutrición
Mexico City, Mexico, 14000
Sponsors and Collaborators
Instituto Nacional de Salud Publica, Mexico
Instituto Nacional de Enfermedades Respiratorias
Instituto Nacional de Ciencias Medicas y Nutrición
Investigators
Principal Investigator: Jose JS Sifuentes -Osornio, Dr Instituto Nacional de Ciencias Médcias y Nutrición
Principal Investigator: Martha MT Torres-Rojas, DCs Instituto Nacional de Enfermedades Respiratorias

Publications of Results:
Responsible Party: Ma. de Lourdes Garcia Garcia, Director of prevention of infectious diseases, Instituto Nacional de Salud Publica, Mexico
ClinicalTrials.gov Identifier: NCT03278483     History of Changes
Other Study ID Numbers: 1341
First Posted: September 11, 2017    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ma. de Lourdes Garcia Garcia, Instituto Nacional de Salud Publica, Mexico:
Latent tuberculosis, ,
isoniazid, rifampin,
rifampin,
adverse,
diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rifampin
Isoniazid
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP2C8 Inducers
Cytochrome P-450 CYP2C19 Inducers
Cytochrome P-450 CYP2C9 Inducers
Cytochrome P-450 CYP3A Inducers
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents