Health TrialsbyHealthPanel

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

ConditionRespiratory Syncytial Virus Infections
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age3-2
SponsorUniversity of Alabama at Birmingham

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • AZM Group

    Drug

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

  • Control Group

    Other intervention

    Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: Control GroupPlacebo comparator 1 intervention
Group B: AZM 20mg/kg Treatment GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of Hospitalization

Duration of hospitalization in days for enrolled subjects

Time frame
At discharge (Approximately 2 weeks)

Secondary outcomes

1

Duration of oxygenation

Duration of oxygenation in days for enrolled subject

Time frame
At discharge (Approximately 1 week)
2

Length of ICU stay

Duration of ICU stay in days for enrolled subjects

Time frame
At ICU discharge (Approximately 1 week)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alabama at Birmingham

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
Apply now