Clinical trial NCT05215990: Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis
Official title: Efficacy of Metformin for Sputum Conversion in Patients With Active Pulmonary Tuberculosis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Tuberculosis, Pulmonary
Keywords: Tuberculosis
Metformin
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Thailand
First posted: 2022-01-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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,

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: 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.
timeFrame: 6 months
Other outcomes:
Locations:
city: Ratchathewi
country: Thailand
facility: Angsana Phuphuakrat
state: ฺBangkok
Study officials:
References:
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citation: Novita BD, Ali M, Pranoto A, Soediono EI, Mertaniasih NM. Metformin induced autophagy in diabetes mellitus - Tuberculosis co-infection patients: A case study. Indian J Tuberc. 2019 Jan;66(1):64-69. doi: 10.1016/j.ijtb.2018.04.003. Epub 2018 Apr 17.
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