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Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children

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ClinicalTrials.gov Identifier: NCT05026749
Recruitment Status : Not yet recruiting
First Posted : August 30, 2021
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Michele Kong, University of Alabama at Birmingham

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: AZM Group Other: Control Group Phase 3

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 5 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Estimated Study Start Date : December 31, 2021
Estimated Primary Completion Date : December 31, 2027
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Control Group Other: Control Group
Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.

Active Comparator: AZM 20mg/kg Treatment Group Drug: AZM Group
AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.




Primary Outcome Measures :
  1. Length of Hospitalization [ Time Frame: Pre-treatment through 2 weeks ]
    Duration of hospitalization in days for enrolled subjects


Secondary Outcome Measures :
  1. Duration of oxygenation [ Time Frame: Pre-treatment through 2 weeks ]
    Duration of oxygenation in days for enrolled subject

  2. Length of ICU stay [ Time Frame: Pre-treatment through 2 weeks ]
    Duration of ICU stay in days for enrolled subjects



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • 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, with a minimum of 5L/min flow for children <5 kg);
  • Enrollment into the study within 48 hours of ICU admission and placement on intensive respiratory support;
  • Age: Neonates-2 years. For those less than 1 week of age, they must have been discharged home from the hospital after their birth.

Exclusion criteria:

  • 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);
  • 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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05026749


Contacts
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Contact: Michele Kong, MD 205-638-9387 mkong@uabmc.edu

Locations
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United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
Contact: Michele Kong, MD    205-638-9387    mkong@uabmc.edu   
Principal Investigator: Michele Kong, MD         
United States, California
University of California San Francisco
San Francisco, California, United States, 94143
Contact: Matt Zinter, MD       Matt.Zinter@ucsf.edu   
United States, Connecticut
Yale School of Medicine
New Haven, Connecticut, United States, 06520-8064
Contact: Vince Faustino, MD       vince.faustino@yale.edu   
United States, District of Columbia
Children's National Hospital
Washington, District of Columbia, United States, 20010
Contact: Michael Bell, MD       mbell@childrensnational.org   
Sub-Investigator: Michael Bell, MD         
United States, Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Contact: Bria Coates, MD       b-coates@northwestern.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
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Principal Investigator: Michele Kong, MD The University of Alabama at Birmingham
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Responsible Party: Michele Kong, PI, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT05026749    
Other Study ID Numbers: IRB-300007862
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: To be determined.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michele Kong, University of Alabama at Birmingham:
RSV
AZM
ICU
Respiratory Support
Children
Additional relevant MeSH terms:
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Respiratory Syncytial Virus Infections
Respiratory Insufficiency
Virus Diseases
Infections
Respiration Disorders
Respiratory Tract Diseases
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections