Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- University of Alabama at Birmingham
- Study ID
- NCT05026749
- Phase
- PHASE3
- Status
- Recruiting
Conditions
- Respiratory Syncytial Virus Infections
Eligibility Criteria
- Sex
- ALL
- Age
- 3 Days - 2 Years
- Healthy Volunteers
- Not accepted
Interventions
- AZM Group — DRUGAZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
- Control Group — OTHERSaline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Study Details
The overarching hypothesis of the ARRC trial is that administration of Azithromycin (AZM) during acute, Respiratory Syncytial Virus (RSV)-induced respiratory failure will be beneficial, mediated through the matrix metalloproteinase (MMP)-9 pathway.
Key Dates
- Start date
- Feb 27, 2022
- Status verified
- Feb 2026
- Primary completion
- Jul 1, 2027
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 370 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: Control Group
- Active Comparator: AZM 20mg/kg Treatment Group
Primary Outcome Measure
Length of Hospitalization [ Time Frame: At discharge (Approximately 2 weeks) ]
Central Contacts
- Michele Kong, MD205-638-9387
Locations (15)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Alabama at Birmingham | Birmingham | Alabama | 35233 | Michele Kong, MD (PRINCIPAL_INVESTIGATOR) |
| University of California San Francisco | San Francisco | California | 94143 | Matt Zinter, MD James Howard, MD |
| Yale School of Medicine | New Haven | Connecticut | 06520-8064 | Vince Faustino, MD |
| Children's National Hospital | Washington D.C. | District of Columbia | 20010 | Michael Shoykhet, MD Michael Shoykhet, MD (SUB_INVESTIGATOR) |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | Bria Coates, MD |
| Riley Children's Health | Indianapolis | Indiana | 46202 | Michael J Hobson, MD |
| St. Louis Children's Hospital | St Louis | Missouri | 63110 | |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | Eleanor Gradidge, MD |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | |
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | Steven Shein, MD |
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | Katherine Bline, MD |
| Oklahoma Health Sciences | Oklahoma City | Oklahoma | 73104 | Christine Allen, MD |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | |
| The University of Texas Southwestern Medical Center | Dallas | Texas | 75247 | |
| University of Utah | Salt Lake City | Utah | 84112 |
Find similar trials in Birmingham, AL
By research site
The University of Alabama at Birmingham· Birmingham, ALUniversity of California San Francisco· San Francisco, CAYale School of Medicine· New Haven, CTChildren's National Hospital· Washington D.C., DCAnn & Robert H. Lurie Children's Hospital of Chicago· Chicago, ILRiley Children's Health· Indianapolis, IN
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