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Azithromycin for Critical Asthma - Pediatrics

ConditionsPediatric AsthmaCritical Illness
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age3-17
SponsorJohns Hopkins All Children's Hospital

About this trial

The CR-AZI Study will assess the immunomodulatory effects of Azithromycin for pediatric Critical Asthma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 3-17 years

Admission to the PICU

Primary diagnosis of critical asthma

Prescription for continuous inhaled beta-agonist therapy and/or intravenous (IV) beta-agonist therapy

Disqualifiers

Critical Congenital Heart Disease Unrepaired

Tracheostomy Dependence at Admission

Ongoing Exposure to Azithromycin or Macrolide Antibiotics for any indication

Past Medical History of Prolonged QT Syndrome or Arrhythmias

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azithromycin

    Drug

    10mg/kg/dose (max dose 500mg) once daily for 3 days

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Azithromycin InterventionExperimental treatment 1 intervention
Group B: Standard CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Plasma Periostin Levels and Degree of Change (e.g., Slope) - Primary Physiologic Efficacy Endpoint

ng/dL

Time frame
24 hours, 48 hours, and 72-hours following enrollment
2

Drug-related adverse event rate (Primary Safety Endpoint)

cumulative incidence rate

Time frame
During hospitalization, approximately 3 days

Secondary outcomes

1

Length of Stay (Secondary Clinical Efficacy Endpoint)

Measured in Days, from Hospitalization in ICU through Discharge from ICU

Time frame
During hospitalization, approximately 3 days
2

Duration of continuous albuterol (Secondary Clinical Efficacy Endpoint)

Measured in Hours from ICU hospitalization through discharge

Time frame
During hospitalization, approximately 3 days
3

Composite use of adjunct asthma treatments (Secondary Clinical Efficacy Endpoint)

Cumulative Frequency of Exposure, from ICU Hospitalization through ICU discharge

Time frame
During hospitalization, approximately 3 days
4

Transcutaneous carbon dioxide levels (Secondary physiologic efficacy Endpoint)

Measured in mmHg of Carbon Dioxide, peak values measured daily at each study visit

Time frame
Enrollment, Day 1, Day 2, Day 3, at ICU Discharge

Other outcomes

Sponsors and contacts

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

Johns Hopkins All Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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