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

Sponsor

University of Alabama at Birmingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT05026749

Collaborator

(none)

370

Enrollment

Locations

Arms

53.1

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

Anticipated 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

Actual Study Start Date :

Feb 27, 2022

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Length of Hospitalization [At discharge (Approximately 2 weeks)]
Duration of hospitalization in days for enrolled subjects

Secondary Outcome Measures

Duration of oxygenation [At discharge (Approximately 1 week)]
Duration of oxygenation in days for enrolled subject
Length of ICU stay [At ICU discharge (Approximately 1 week)]
Duration of ICU stay in days for enrolled subjects

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Days to 2 Years

Sexes Eligible for Study:

All

Accepts 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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	University of California San Francisco	San Francisco	California	United States	94143
3	Yale School of Medicine	New Haven	Connecticut	United States	06520-8064
4	Children's National Hospital	Washington	District of Columbia	United States	20010
5	Ann & Robert H. Lurie Children's Hospital of Chicago	Chicago	Illinois	United States	60611