Efficacy, Security, Adherence, Tolerability and Cost Effectiveness of Latent TB Treatment in Patients With TB/DM2 (TBL) (TBL)
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|ClinicalTrials.gov Identifier: NCT03278483|
Recruitment Status : Active, not recruiting
First Posted : September 11, 2017
Last Update Posted : September 11, 2017
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|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- Adherence [ Time Frame: Up to 6 months ]Counting the number of administered pills, adequate adherence is more than 80% of administered pills.
- Toxicity (liver function) [ Time Frame: Up to 6 months ]Liver function tests
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
|Instituto Nacional de Ciencias Medicas y Nutrición|
|Mexico City, Mexico, 14000|
|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|