search
Back to results

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

Primary Purpose

Respiratory Syncytial Virus Infections

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
AZM Group
Control Group
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Syncytial Virus Infections focused on measuring RSV, AZM, ICU, Respiratory Support, Children

Eligibility Criteria

3 Days - 2 Years (Child)All SexesDoes not accept healthy volunteers

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;
  • 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.

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 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).

Sites / Locations

  • The University of Alabama at BirminghamRecruiting
  • University of California San FranciscoRecruiting
  • Yale School of MedicineRecruiting
  • Children's National HospitalRecruiting
  • Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Control Group

AZM 20mg/kg Treatment Group

Arm Description

Outcomes

Primary Outcome Measures

Length of Hospitalization
Duration of hospitalization in days for enrolled subjects

Secondary Outcome Measures

Duration of oxygenation
Duration of oxygenation in days for enrolled subject
Length of ICU stay
Duration of ICU stay in days for enrolled subjects

Full Information

First Posted
August 24, 2021
Last Updated
November 22, 2022
Sponsor
University of Alabama at Birmingham
search

1. Study Identification

Unique Protocol Identification Number
NCT05026749
Brief Title
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Official Title
Azithromycin Treatment for Respiratory Syncytial Virus-induced Respiratory Failure in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2022 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Syncytial Virus Infections
Keywords
RSV, AZM, ICU, Respiratory Support, Children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
370 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Title
AZM 20mg/kg Treatment Group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
AZM Group
Intervention Description
AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Intervention Type
Other
Intervention Name(s)
Control Group
Intervention Description
Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
Primary Outcome Measure Information:
Title
Length of Hospitalization
Description
Duration of hospitalization in days for enrolled subjects
Time Frame
At discharge (Approximately 2 weeks)
Secondary Outcome Measure Information:
Title
Duration of oxygenation
Description
Duration of oxygenation in days for enrolled subject
Time Frame
At discharge (Approximately 1 week)
Title
Length of ICU stay
Description
Duration of ICU stay in days for enrolled subjects
Time Frame
At ICU discharge (Approximately 1 week)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Days
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility 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 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. 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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michele Kong, MD
Phone
205-638-9387
Email
mkong@uabmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Kong, MD
Organizational Affiliation
The University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Kong, MD
Phone
205-638-9387
Email
mkong@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Michele Kong, MD
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt Zinter, MD
Email
Matt.Zinter@ucsf.edu
First Name & Middle Initial & Last Name & Degree
James Howard, MD
Email
James.Howard@ucsf.edu
Facility Name
Yale School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8064
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vince Faustino, MD
Email
vince.faustino@yale.edu
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bell, MD
Email
mbell@childrensnational.org
First Name & Middle Initial & Last Name & Degree
Michael Bell, MD
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bria Coates, MD
Email
b-coates@northwestern.edu

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
To be determined.

Learn more about this trial

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

We'll reach out to this number within 24 hrs