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Macrolide Antibiotic

Azithromycin for Wheezing in Preschoolers (AZ-SWED Trial)

Q: What is the cap for participators in this clinical trial?

Correct. The information hosted on clinicaltrials.gov verifies that this medicinal experiment, which was first posted on September 22nd 2021, is still actively recruiting participants across 6 sites for a total of 1476 patients.

Q: Does Treatment - Active meet the regulatory standards set forth by the FDA?

The team at Power rated the safety of Treatment - Active as a 3 due to prior clinical evidence supporting efficacy, in addition to multiple rounds of data demonstrating its safety.

Q: Does the protocol for this experiment require participants to be over 25 years of age?

For this clinical study, only patients falling within the 18-month to 5 year age range are eligible. 186 trials target children younger than 18 months while 392 studies focus on seniors above 65 years of age.

Q: Is there a possibility for me to participate in this experiment?

This medical study is seeking 1476 toddlers and children with <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a>. The patient's age must be between 18 months old to 5 years of age, they need to have exhibited expiratory wheezing during their emergency department visit, and a Pediatric Respiratory Assessment Measurement score higher than or equal to 4 at any time during the ED stay.

Q: Are there any vacancies left in this trial for participants?

Data hosted on clinicaltrials.gov verify that this medical trial is actively looking for participants, having been originally published on September 22nd 2021 and updated most recently on November 30th 2022.

Q: How many medical centers are currently hosting this clinical trial?

Patients are being admitted to the Children's Hospital of <a href="https://www.withpower.com/clinical-trials/new-york">New york</a> Medical Center in Manhattan, Cincinnati Children's Hospital Medical Centre, and Boston Children's Hospital. Additionally, 6 more medical centres will be incorporated into this trial.

Q: Has Treatment - Active been evaluated in any prior investigations?

Presently, there are 55 active clinical trials investigating Treatment - Active. Of which 18 of these inquiries have advanced to Phase 3 testing. Though most studies are held in Albuquerque, <a href="https://www.withpower.com/clinical-trials/new-mexico">New mexico</a>, altogether 694 sites accommodate this treatment's research.

Q: What medical conditions have been demonstrated to respond positively to Treatment - Active?

Administration of Treatment - Active is a typical remedy for genital ulcer disease (GUD). Moreover, it can help treat chlamydia in adults and cervicitis.

Phase 3

Recruiting

Led By Charlie Casper, PhD

Research Sponsored by University of Arizona

Eligibility Criteria Checklist

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

Must have

Age 18 months to <60 months

The presence of expiratory wheezing as ascertained by a physician or nurse practitioner at admission to the ED

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 72 hours after randomization

Awards & highlights

AZ-SWED Trial Summary

This trial will compare the 5-day outcome of preschool children presenting to an Emergency Department (ED) with an acute, severe wheezing episode and treated with either once daily oral Azithromycin (12 mg/kg/day for 5 days) or placebo.

Who is the study for?

This trial is for preschool children aged 18 months to under 60 months who are experiencing a severe wheezing episode and have been assessed at the emergency department. They must not have used antibiotics or steroids for wheezing in the past two weeks, among other health criteria.Check my eligibility

What is being tested?

The AZ-SWED study tests if Azithromycin (12 mg/kg/day for 5 days) helps improve severe wheezing episodes in young children compared to a placebo. The effect is measured using daily caregiver reports and follow-up visits, with some focus on bacterial presence.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones from Azithromycin may include stomach upset, diarrhea, nausea, vomiting and potential allergic reactions. Monitoring during the trial will assess any complications.

AZ-SWED Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I am between 18 and 59 months old.

Select...

A doctor or nurse heard wheezing when I breathed out during my ED visit.

AZ-SWED Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 72 hours after randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~72 hours after randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours after randomization for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Asthma

Secondary outcome measures

Length of Stay

Azithromycin

AZ-SWED Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Treatment - ActiveActive Control1 Intervention

Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered the active drug per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.

Group II: Treatment - PlaceboPlacebo Group1 Intervention

Eligible patients will be randomly assigned to one of two treatment groups (1:1) and one arm will be administered placebo per the randomization schedule. Study medication will be provided to parents/guardians, along with instructions, for home-based administration. The first dose of the study medication will be administered before discharge from the ED.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor

514 Previous Clinical Trials

147,118 Total Patients Enrolled

8 Trials studying Asthma

1,986 Patients Enrolled for Asthma

University of UtahOTHER

1,099 Previous Clinical Trials

1,777,213 Total Patients Enrolled

5 Trials studying Asthma

175,031 Patients Enrolled for Asthma

Emory UniversityOTHER

1,639 Previous Clinical Trials

2,559,170 Total Patients Enrolled

11 Trials studying Asthma

1,639 Patients Enrolled for Asthma

Media Library

Azithromycin (Macrolide Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04669288 — Phase 3

Asthma Research Study Groups: Treatment - Active, Treatment - Placebo

Asthma Clinical Trial 2023: Azithromycin Highlights & Side Effects. Trial Name: NCT04669288 — Phase 3

Azithromycin (Macrolide Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04669288 — Phase 3

Frequently Asked Questions

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

What is the cap for participators in this clinical trial?

"Correct. The information hosted on clinicaltrials.gov verifies that this medicinal experiment, which was first posted on September 22nd 2021, is still actively recruiting participants across 6 sites for a total of 1476 patients."

Answered by AI

Does Treatment - Active meet the regulatory standards set forth by the FDA?

"The team at Power rated the safety of Treatment - Active as a 3 due to prior clinical evidence supporting efficacy, in addition to multiple rounds of data demonstrating its safety."

Answered by AI

Does the protocol for this experiment require participants to be over 25 years of age?

"For this clinical study, only patients falling within the 18-month to 5 year age range are eligible. 186 trials target children younger than 18 months while 392 studies focus on seniors above 65 years of age."

Answered by AI

Is there a possibility for me to participate in this experiment?

"This medical study is seeking 1476 toddlers and children with asthma. The patient's age must be between 18 months old to 5 years of age, they need to have exhibited expiratory wheezing during their emergency department visit, and a Pediatric Respiratory Assessment Measurement score higher than or equal to 4 at any time during the ED stay."

Answered by AI

Are there any vacancies left in this trial for participants?

"Data hosted on clinicaltrials.gov verify that this medical trial is actively looking for participants, having been originally published on September 22nd 2021 and updated most recently on November 30th 2022."

Answered by AI

How many medical centers are currently hosting this clinical trial?

"Patients are being admitted to the Children's Hospital of New york Medical Center in Manhattan, Cincinnati Children's Hospital Medical Centre, and Boston Children's Hospital. Additionally, 6 more medical centres will be incorporated into this trial."

Answered by AI

Has Treatment - Active been evaluated in any prior investigations?

"Presently, there are 55 active clinical trials investigating Treatment - Active. Of which 18 of these inquiries have advanced to Phase 3 testing. Though most studies are held in Albuquerque, New mexico, altogether 694 sites accommodate this treatment's research."

Answered by AI

What medical conditions have been demonstrated to respond positively to Treatment - Active?

"Administration of Treatment - Active is a typical remedy for genital ulcer disease (GUD). Moreover, it can help treat chlamydia in adults and cervicitis."

Answered by AI