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Macrolide Antibiotic

Azithromycin for MAC Infection

Q: What is the participant count for this research endeavor?

Indeed, the information on clinicaltrials.gov speaks to this study's active recruitment status. It was first published on February 24th 2020 and has been subsequently edited as recently as March 7th 2022. The research is looking for 30 volunteers from a single site.

Q: Is Azithromycin a reliable treatment with negligible risks?

Azithromycin's safety rating is a 2, reflecting the fact that while there has been some evidence of its security, no data exists to verify its efficacy.

Q: What qualifications must participants fulfill in order to be eligible for this research project?

A total of 30 individuals between the ages 18-100 with a diagnosis of mycobacterium avium complex infection are eligible for this trial. Furthermore, to qualify for participation, patients must fulfill American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) criteria for <a href="https://www.withpower.com/clinical-trials/mac">MAC</a> lung disease and be capable of producing at least 10mL sputum over 16 hours; they also need to provide signed informed consent.

Q: Are any individuals currently being sought for involvement in this experiment?

The latest update on clinicaltrials.gov shows that this medical trial, which was initially publicized on February 24th 2020, is still searching for suitable participants. The record of the study was last edited in March 7th 2022.

Q: What previous research has focused on Azithromycin?

At the present moment, 54 studies are underway exploring Azithromycin. 17 of those clinical trials have entered into Phase 3 and 688 facilities around the world are taking part in these investigations. The majority of research sites for this medication are situated in Albuquerque, <a href="https://www.withpower.com/clinical-trials/new-mexico">New mexico</a>.

Q: For which health issues is Azithromycin usually prescribed?

Azithromycin can be prescribed for adults suffering from genital ulcer disease (GUD) and infections caused by the genus Chlamydia.

Q: Is the age of admittance to this clinical research inclusive of individuals over sixty?

According to the inclusion criteria, individuals eligible for this trial range from 18 years of age up to 100. For patients outside those parameters, there are 34 trials available below 18 and 55 options above 65.

Phase 2

Recruiting

Led By Keira A Cohen, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Ability to produce a sputum sample of at least 10mL in a 16 hour period

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 2 months

Awards & highlights

Study Summary

This trial looks at the effectiveness of the antibiotic azithromycin in treating MAC lung disease.

Who is the study for?

This trial is for adults over 18 with MAC lung disease, as defined by ATS/IDSA criteria. Participants must have had a positive test for M. avium complex in the last 6 months and be able to produce a sputum sample. They cannot join if they've had an organ transplant, are allergic to azithromycin, were treated for MAC recently, are pregnant or have HIV with CD4 <350.Check my eligibility

What is being tested?

The study tests Azithromycin's effectiveness against Mycobacterium avium complex (MAC) infection over the first two weeks of treatment. Patients will take 250mg of Azithromycin orally every day.See study design

What are the potential side effects?

Azithromycin may cause side effects like stomach upset, diarrhea, nausea, vomiting and can sometimes lead to more serious conditions such as liver problems or heart rhythm changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I can produce a large enough sputum sample within 16 hours.

Select...

I meet the criteria for MAC lung disease as per ATS/IDSA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 2 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 2 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 2 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in time to positivity of Mycobacterium avium growth in the Mycobacterial Growth Indicator Tube (MGIT)

Secondary outcome measures

Change in Mycobacterium avium colony count in sputum

Change in time to positivity of Mycobacterium avium growth in MGIT

Estimation of maximum plasma concentration (Cmax) of azithromycin

+1 more

Side effects data

From 2018 Phase 4 trial • 190238 Patients • NCT02047981

Death

100%

80%

60%

40%

20%

Study treatment Arm

Biannual Mass Oral Placebo

Biannual Mass Oral Azithromycin

Trial Design

1Treatment groups

Experimental Treatment

Group I: 14 Day Azithromycin MonotherapyExperimental Treatment1 Intervention

For the first 14 days of therapy, participants will receive Azithromycin 250mg PO daily as monotherapy. Beyond day 14, all participants will receive guideline-based standard multi-drug therapy for Mycobacterium avium lung disease, as dictated by the physicians treating the participants.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Azithromycin

2018

Completed Phase 4

~274950

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor

2,263 Previous Clinical Trials

14,823,135 Total Patients Enrolled

Keira A Cohen, MDPrincipal InvestigatorJohns Hopkins University

Elisa H Ignatius, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04287049 — Phase 2

Mycobacterium Avium Complex Infection Research Study Groups: 14 Day Azithromycin Monotherapy

Mycobacterium Avium Complex Infection Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT04287049 — Phase 2

Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04287049 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant count for this research endeavor?

"Indeed, the information on clinicaltrials.gov speaks to this study's active recruitment status. It was first published on February 24th 2020 and has been subsequently edited as recently as March 7th 2022. The research is looking for 30 volunteers from a single site."

Answered by AI

Is Azithromycin a reliable treatment with negligible risks?

"Azithromycin's safety rating is a 2, reflecting the fact that while there has been some evidence of its security, no data exists to verify its efficacy."

Answered by AI

What qualifications must participants fulfill in order to be eligible for this research project?

"A total of 30 individuals between the ages 18-100 with a diagnosis of mycobacterium avium complex infection are eligible for this trial. Furthermore, to qualify for participation, patients must fulfill American Thoracic Society (ATS)/Infectious Diseases Society of America (IDSA) criteria for MAC lung disease and be capable of producing at least 10mL sputum over 16 hours; they also need to provide signed informed consent."

Answered by AI

Are any individuals currently being sought for involvement in this experiment?

"The latest update on clinicaltrials.gov shows that this medical trial, which was initially publicized on February 24th 2020, is still searching for suitable participants. The record of the study was last edited in March 7th 2022."

Answered by AI

What previous research has focused on Azithromycin?

"At the present moment, 54 studies are underway exploring Azithromycin. 17 of those clinical trials have entered into Phase 3 and 688 facilities around the world are taking part in these investigations. The majority of research sites for this medication are situated in Albuquerque, New mexico."

Answered by AI

For which health issues is Azithromycin usually prescribed?

"Azithromycin can be prescribed for adults suffering from genital ulcer disease (GUD) and infections caused by the genus Chlamydia."

Answered by AI

Is the age of admittance to this clinical research inclusive of individuals over sixty?

"According to the inclusion criteria, individuals eligible for this trial range from 18 years of age up to 100. For patients outside those parameters, there are 34 trials available below 18 and 55 options above 65."

Answered by AI