Respiratory Syncytial Virus InfectionsPhase 3NCT05026749
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
A Phase 3 study testing AZM Group in people with Respiratory Syncytial Virus Infections, run by University of Alabama at Birmingham at 15 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 days to 2 years
- Conditions the study is for
- Respiratory Syncytial Virus Infections
- What is being tested?
- AZM Group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 15 sitesUnited States
- Study dates
- 27 Feb 2022to 31 Jul 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 days to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admission to the pediatric ICU with a confirmed diagnosis of RSV infection. RSV infection is based on a positive nasal swab for RSV fluorescent antibody or via multiplex assay or culture;
- Requiring intensive respiratory support defined as either mechanical ventilation or NIV (BiPAP or CPAP) or HFNC (at >1 L/kg/min of flow
- Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
- Onset of RSV-related symptoms must be less than 5 days
- Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.
Who cannot join
- AZM use within 7 days of ICU admission;
- Contraindication to AZM use including known hypersensitivity to AZM, erythromycin, any macrolide, or ketolide drug, patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL or ALT ≥ 10 times the upper limits of normal);
- Patients with known cardiac disease, cardiac arrhythmia or with electrocardiogram QT interval corrected for heart rate (QTc) ≥ 450 milisecond (ms);
- Intensive respiratory support greater than 48 hours prior to ICU admission;
- Chronic ventilation or supplemental oxygen need at home;
- Immunosuppressive conditions such as those post heart or hematopoietic stem cell transplant or receiving chemotherapy and chronic steroids;
- History of pyloric stenosis;
- AZM is deemed necessary for clinical treatment (for instance, if patient has pertussis).
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
The University of Alabama at Birmingham
Birmingham, Alabama, 35233
Michele Kong, MD, 205-638-9387, mkong@uabmc.edu
Michele Kong, MD
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Tracie Walker, MD, 9198431577, tracie_walker@med.unc.edu
- Recruiting
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Bria Coates, MD, b-coates@northwestern.edu
- Recruiting
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
Steven Shein, MD, Steven.Shein@UHhospitals.org
- Recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Katherine Bline, MD, katherine.bline@nationwidechildrens.org
- Recruiting
The University of Texas Southwestern Medical Center
Dallas, Texas, 75247
Ananya Manchikalapati, MD, 2144561600, ananya.manchikalapati@UTsouthwestern.edu
- Recruiting
Riley Children's Health
Indianapolis, Indiana, 46202
Michael J Hobson, MD, mjhobson@iu.edu
- Recruiting
Yale School of Medicine
New Haven, Connecticut, 06520-8064
Vince Faustino, MD, vince.faustino@yale.edu
- Recruiting
Oklahoma Health Sciences
Oklahoma City, Oklahoma, 73104
Christine Allen, MD, Christine-allen@ouhsc.edu
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Eleanor Gradidge, MD, egradidge@childrensnebraska.org
- Recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Garrett Keim, MD, 215-590-3800, keimG@chop.edu
- Recruiting
University of Utah
Salt Lake City, Utah, 84112
Kevin Watt, MD, 801-587-7404, kevin.watt@hsc.utah.edu
- Recruiting
University of California San Francisco
San Francisco, California, 94143
Matt Zinter, MD, Matt.Zinter@ucsf.edu
James Howard, MD, James.Howard@ucsf.edu
- Recruiting
St. Louis Children's Hospital
St Louis, Missouri, 63110
Ashley Turner, MD, (314) 454-6000, ashley.turner@wustl.edu
- Recruiting
Children's National Hospital
Washington D.C., District of Columbia, 20010
Michael Shoykhet, MD, mshoykhet@childrensnational.org
Michael Shoykhet, MD
About this study
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.
Read the detailed description
The proposed study will be a randomized, double-blinded, placebo-controlled Phase III trial to examine the efficacy of AZM therapy relative to placebo in reducing RSV-related morbidity. Patients will be recruited during acute hospitalization and admission to the ICU at 10 pediatric hospitals. The target population selected is pediatric patients with severe RSV lung disease as defined by need for ICU management and intensive respiratory support.
- Conditions
- Respiratory Syncytial Virus Infections
- Being tested
- AZM Group, Control Group
- Keywords
- RSV, AZM, ICU, Respiratory Support, Children
- Medical subject headings
- Respiratory Syncytial Virus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AZM GroupDrug
AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Control GroupOther
Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Not described Receives: Other: Control Group |
| AZM 20mg/kg Treatment Group | Active comparator | Not described Receives: Drug: AZM Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospitalization
Duration of hospitalization in days for enrolled subjects
Measured: At discharge (Approximately 2 weeks)
Secondary outcomes (2)
Duration of oxygenation
Duration of oxygenation in days for enrolled subject
Measured: At discharge (Approximately 1 week)
Length of ICU stay
Duration of ICU stay in days for enrolled subjects
Measured: At ICU discharge (Approximately 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start27 Feb 2022
- Primary completion1 Jul 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus InfectionsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Michele Kong, MD, University of Alabama at Birmingham
- Investigators
- Michele Kong, MD, Principal investigator, The University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026749
- Sponsor's protocol ID
- IRB-300007862
- Other IDs
- 1R01HD105678-01
- Status last verified
- Feb 2026
- First submitted
- 24 Aug 2021
- Last updated
- 9 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined.