Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis

Study Overview
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Brief Summary
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This study was a randomized controlled trial studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients between metformin with pulmonary tuberculosis standard treatment group and placebo drug with pulmonary tuberculosis standard treatment.

Detailed Description
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Pulmonary tuberculosis Patients with presence of at least one acid-fast bacillus in the sputum will be examined by an internist. Collect the necessary basic information of patients who agree to participate in the treatment such as complete blood count, blood urea nitrogen, creatinine, liver function test, fasting plasma glucose, hemoglobinA1C, lactate, and gene expression signature for tuberculosis. Patients will be randomized into 2 groups: those who will receive metformin with pulmonary tuberculosis standard treatment and those who will receive placebo drug with pulmonary tuberculosis standard treatment. Patients will get a chest x-ray and collect sputum acid fast bacillus, sputum culture for tuberculosis and collect blood sample laboratory such as complete blood count, liver function test, creatinine, fasting plasma glucose, lactate, and gene expression signature for tuberculosis at second week. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at second month. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at fifth month. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at sixth month. After collecting all information of patients, Investigators will analyze in clinical and statistical analysis.

Official Title
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Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis: A Randomized Controlled Trial

Conditions
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Tuberculosis, Pulmonary

Intervention / Treatment
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* Drug: MetFORMIN 500 Mg Oral Tablet
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age more than 18 years old Be diagnosed pulmonary tuberculosis compatible with clinical and chest x ray by an internist Presence of at least one acid -fast bacillus in the sputum Recieve pulmonary tuberculosis standard treatment compose of isoniazid, rifampicin, pyrazinamide and ethambutol BMI more than 18.5 kg/m2 Reserach participants were diagnosed diabetes or non diabetes. Research participants or representatives are welcome to join the project by signing. Exclusion Criteria: Pregnancy Organ transplants eGFR less than 45 ml/min/1.73 m2 AST, ALT or total bilirubin more than three times Researh participants have received metformin at least 2 weeks before joining the project. Immunocompromised host such as patient receive systemic immunosuppressive drugs or systemic chemotherapy. Research participant or his representative refuses or requests to withdraw,

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patient receive metformin with pulmonary tuberculosis standard treatment.<br>Patient receive pulmonary tuberculosis standard treatment: isoniazid, rifampicin, pyrazinamide, and ethambutol in first and second month(weight adjusted dose), then in third to sixth month switch tuberculosis standard treatment to isoniazid and rifampicin(weight adjusted dose). In all 6 months, patient receive metformin (500 mg) 1 tablet simultaneously. | Drug: MetFORMIN 500 Mg Oral Tablet<br>* studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients receive metformin with pulmonary tuberculosis standard treatment group in second week, second, fifth, and sixth month.<br>|
| Placebo Comparator: Patient receive placebo drug with pulmonary tuberculosis standard treatment.<br>Patient receive pulmonary tuberculosis standard treatment: isoniazid, rifampicin, pyrazinamide, and ethambutol in first and second month(weight adjusted dose), then in third to sixth month switch tuberculosis standard treatment to isoniazid and rifampicin(weight adjusted dose). In all 6 months, patient receive placebo drug 1 tablet simultaneously. | Drug: Placebo<br>* studying about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients receive placebo drug with pulmonary tuberculosis standard treatment group in second week, second, fifth, and sixth month.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study about acid-fast bacillus sputum conversion ratio from positive to negative of pulmonary tuberculosis patients between metformin and placebo drug with pulmonary tuberculosis standard treatment. | patient will be collected sputum acid fast bacillus and sputum culture for tuberculosis in second week, second, fifth, sixth month. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study about side effect such as nausea, vomit, hepatitis between patients use metformin with pulmonary tuberculosis standard treatment and patients use placebo drug with pulmonary tuberculosis standard treatment. | To compare incidence rate of side effect between patients use metformin with pulmonary tuberculosis standard treatment and patients use placebo drug with pulmonary tuberculosis standard treatment. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, Metformin