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

  • STATUS
    Recruiting
  • End date
    Mar 31, 2023
  • participants needed
    80
  • sponsor
    Mahidol University
Updated on 23 March 2022

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.

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.

Details
Condition Tuberculosis, Pulmonary
Treatment Placebo, MetFORMIN 500 Mg Oral Tablet
Clinical Study IdentifierNCT05215990
SponsorMahidol University
Last Modified on23 March 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note