Early Bactericidal Activity of Standard Drugs Used to Treat Mycobacterium Avium Complex: a Pilot Study

  • STATUS
    Recruiting
  • participants needed
    30
  • sponsor
    Johns Hopkins University
Send
Updated on 16 February 2024
See if I qualify
pulmonary disease
azithromycin
lung disease
mycobacterium avium complex
azithormycin
mycobacterial infections
mycobacterium avium complex infection
mycobacterium avium-intracellulare infection

Summary

To assess the early bactericidal activity of Azithromycin 250mg by mouth daily over the first 14 days of treatment for Mycobacterium avium complex (MAC) lung disease.

Description

This research is being done to better understand several important aspects of treatment of Mycobacterium avium complex (MAC) lung infections using an early bactericidal activity (EBA) study design. MAC is an environmental bacteria that can cause chronic lung infection. Early bactericidal activity is the amount of bacterial killing that occurs during the first few weeks of antibiotic treatment. By collecting information about the EBA of azithromycin for MAC, the investigators will quantify the efficacy of azithromycin against pulmonary MAC.

Details
Condition Mycobacterium avium-intracellulare Infection, Mycobacterium avium Complex
Age 18years - 100years
Treatment Azithromycin
Clinical Study IdentifierNCT04287049
SponsorJohns Hopkins University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age 18 years
Isolation of M. avium intracellulare complex from a respiratory specimen in the preceding 6 months
Fulfill American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) criteria for MAC lung disease
Intention by the treating clinician to treat for MAC lung disease
Ability to produce a sputum sample of at least 10mL in a 16 hour period
Signed informed consent by the subject

Exclusion Criteria

Prior treatment for pulmonary MAC within the past 6 months
Pregnancy
HIV with a cluster of differentiation 4 (CD4) <350
History of solid organ or hematologic transplant
Contraindication to azithromycin
Has any other condition that, in the opinion of the PI, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

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

Browse trials for

pulmonary disease
azithromycin
lung disease
mycobacterium avium complex
azithormycin
mycobacterial infections
mycobacterium avium complex infection
mycobacterium avium-intracellulare infection

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