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

NCT05215990 | Unknown Phase 1

• 1 other identifier: MURA2021/816
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Tuberculosis, Pulmonary

Keywords

Tuberculosis; Metformin

Outcome Measures

Primary Outcomes (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.

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

  6 months

Secondary Outcomes (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

Study Arms (2)

Patient receive metformin with pulmonary tuberculosis standard treatment.

ACTIVE COMPARATOR

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

Patient receive placebo drug with pulmonary tuberculosis standard treatment.

PLACEBO COMPARATOR

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

Interventions

MetFORMIN 500 Mg Oral Tablet DRUG

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.

Patient receive metformin with pulmonary tuberculosis standard treatment.

Placebo DRUG

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.

Patient receive placebo drug with pulmonary tuberculosis standard treatment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Mahidol University: lead
• Ministry of Health, Thailand: collaborator

Study Sites (1)

Angsana Phuphuakrat

Ratchathewi, ฺBangkok, 10400, Thailand

RECRUITING

Related Publications (8)

• Singhal A, Jie L, Kumar P, Hong GS, Leow MK, Paleja B, Tsenova L, Kurepina N, Chen J, Zolezzi F, Kreiswirth B, Poidinger M, Chee C, Kaplan G, Wang YT, De Libero G. Metformin as adjunct antituberculosis therapy. Sci Transl Med. 2014 Nov 19;6(263):263ra159. doi: 10.1126/scitranslmed.3009885.

  PMID: 25411472 BACKGROUND

• Lee YJ, Han SK, Park JH, Lee JK, Kim DK, Chung HS, Heo EY. The effect of metformin on culture conversion in tuberculosis patients with diabetes mellitus. Korean J Intern Med. 2018 Sep;33(5):933-940. doi: 10.3904/kjim.2017.249. Epub 2018 Mar 16.

  PMID: 29540054 BACKGROUND

• Degner NR, Wang JY, Golub JE, Karakousis PC. Metformin Use Reverses the Increased Mortality Associated With Diabetes Mellitus During Tuberculosis Treatment. Clin Infect Dis. 2018 Jan 6;66(2):198-205. doi: 10.1093/cid/cix819.

  PMID: 29325084 BACKGROUND

• Yu X, Li L, Xia L, Feng X, Chen F, Cao S, Wei X. Impact of metformin on the risk and treatment outcomes of tuberculosis in diabetics: a systematic review. BMC Infect Dis. 2019 Oct 17;19(1):859. doi: 10.1186/s12879-019-4548-4.

  PMID: 31623569 BACKGROUND

• Lashen H. Role of metformin in the management of polycystic ovary syndrome. Ther Adv Endocrinol Metab. 2010 Jun;1(3):117-28. doi: 10.1177/2042018810380215.

  PMID: 23148156 BACKGROUND

• Ning HH, Le J, Wang Q, Young CA, Deng B, Gao PX, Zhang HQ, Qin SL. The effects of metformin on simple obesity: a meta-analysis. Endocrine. 2018 Dec;62(3):528-534. doi: 10.1007/s12020-018-1717-y. Epub 2018 Aug 27.

  PMID: 30151735 BACKGROUND

• 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.

  PMID: 30797286 BACKGROUND

• Vashisht R, Brahmachari SK. Metformin as a potential combination therapy with existing front-line antibiotics for Tuberculosis. J Transl Med. 2015 Mar 7;13:83. doi: 10.1186/s12967-015-0443-y.

  PMID: 25880846 RESULT

Related Links

• Clinical Evaluation of Efficacy and Safety of Metformin add-on Therapy to Standard ATT in Newly Diagnosed Pulmonary Tuberculosis Patients

MeSH Terms

Conditions

Tuberculosis, Pulmonary; Tuberculosis

Interventions

Metformin; Tablets

Condition Hierarchy (Ancestors)

Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Angsana Phuphuakrat, MD, PhD

CONTACT

6622011581; angsana.phu@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: January 31, 2022
• Study Start: January 15, 2022
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: February 14, 2022

Record last verified: 2022-01

Locations

TH (1)