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

Sponsor
Mahidol University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05215990
Collaborator
Ministry of Health, Thailand (Other)
80
1
2
14.5
5.5

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: MetFORMIN 500 Mg Oral Tablet
  • Drug: Placebo
Phase 1/Phase 2

Detailed Description

  1. Pulmonary tuberculosis Patients with presence of at least one acid-fast bacillus in the sputum will be examined by an internist.

  2. 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.

  3. 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.

  4. 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.

  5. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at second month.

  6. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at fifth month.

  7. Patients will get a chest x-ray and collect sputum acid fast bacillus, and sputum culture for tuberculosis at sixth month.

  8. After collecting all information of patients, Investigators will analyze in clinical and statistical analysis.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis: A Randomized Controlled Trial
Actual Study Start Date :
Jan 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Patient receive metformin with pulmonary tuberculosis standard treatment.

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
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.

Placebo Comparator: Patient receive placebo drug with pulmonary tuberculosis standard treatment.

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
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.

Outcome Measures

Primary Outcome Measures

  1. 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. [6 months]

    patient will be collected sputum acid fast bacillus and sputum culture for tuberculosis in second week, second, fifth, sixth month.

Secondary Outcome Measures

  1. 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. [6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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,

Contacts and Locations

Locations

Site City State Country Postal Code
1 Angsana Phuphuakrat Ratchathewi ฺBangkok Thailand 10400

Sponsors and Collaborators

  • Mahidol University
  • Ministry of Health, Thailand

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Angsana Phuphuakrat, Principal investigator, Mahidol University
ClinicalTrials.gov Identifier:
NCT05215990
Other Study ID Numbers:
  • MURA2021/816
First Posted:
Jan 31, 2022
Last Update Posted:
Feb 14, 2022
Last Verified:
Jan 1, 2022
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 Angsana Phuphuakrat, Principal investigator, Mahidol University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 14, 2022