Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children

Respiratory Syncytial Virus Clinical Trial

Official title:

Prospective Pilot Clinical Trial of Azithromycin Treatment In RSV-induced Respiratory Failure In Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707523
• Other study ID #: FWA00005960
• Status: Completed
• Phase: Phase 2
• Start date: January 1, 2016
• Est. completion date: June 20, 2020

Study information

• Verified date: July 2020
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized, double-blind, placebo-controlled phase 2 trial will be conducted at a single tertiary pediatric intensive care unit (PICU). The study will include children with RSV infection who were admitted to the pediatric intensive care unit and require respiratory support via positive pressure ventilation (invasive and noninvasive).

Description:

Eligible participants include all children admitted to the PICU at Children's of Alabama with a diagnosis of RSV infection and requiring positive pressure ventilation, invasive or noninvasive, including bilevel positive airway pressure (BiPAP) or high flow nasal cannula (HFNC) oxygen (ie, >1 L/kg/min of flow, with 5 L/min flow for children weighing <5 kg). During hospitalization, all patients will be treated according to the American Academy of Pediatrics guidelines for the management of bronchiolitis, primarily supportive care. Participants will then be randomized according to a permuted-block design to receive either placebo (saline) or AZM (Fresenius Kabi) at 10mg/kg/d (ie, standard dose) or 20mg/kg/d (ie, high dose) intravenously every 24 hours for 3 days. All biologic samples collected will be analyzed in the PI's lab at the University of Alabama at Birmingham. Drug pharmacokinetics will be performed at the Pharmaceutical Sciences Research Institute of Samford University, Birmingham, AL.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 20, 2020
• Est. primary completion date: February 6, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• Admission to the PICU with RSV infection

• Need for positive pressure ventilation (invasive and non-invasive)

• Randomization and drug/placebo initiation within 48 hours of admission to Pediatric Intensive Care Unit

Exclusion Criteria:

• Azithromycin use within 7 days of PICU admission

• Contraindication to azithromycin use including:

• Patients with electrocardiogram QT interval corrected for heart rate (Qtc) = 450 ms

• Patients with significant hepatic impairment (direct bilirubin >1.5 mg/dL)

• Known hypersensitivity to azithromycin, erythromycin, any macrolide, or ketolide drug

• Cardiac arrhythmia

• History of pyloric stenosis

• Immunocompromised children (any cause)

• Current use of any medication known to cause QT prolongation

Related Conditions & MeSH terms

• Respiratory Insufficiency
• Respiratory Syncytial Virus

Intervention

Drug:
• Azithromycin 10 mg

• Azithromycin 20mg

• Placebo

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lung Matrix Metalloproteinase (MMP) Level	To determine the concentration of MMP-9 levels in the lung compartment	Day 3
Primary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	To determine the safety profile of AZM at 10 mg/kg and 20 mg/kg IV X 3 days in children with RSV-induced respiratory failure	Baseline through Day 3
Primary	Nasal Total Matrix Metalloproteinase (MMP)-9 Level	To determine the concentration of total MMP-9 levels in the nasal compartment	Day 3
Primary	Pharmacokinetic-Plasma Half Life of AZM	Measurement of AZM half life in the plasma	From baseline to 72 hours post treatment
Primary	Pharmacokinetic-Lung Half Life of AZM	Measurement of AZM half life in the lung	From baseline to 72 hours post treatment
Secondary	Duration of Mechanical Ventilation in Days	Duration of mechanical ventilation in days for enrolled subjects	Pre-treatment through 2 weeks
Secondary	Duration of BiPAP in Days	Duration of BiPAP in days for enrolled subjects	Pre-treatment through 2 weeks
Secondary	Duration of High Flow Nasal Cannula in Days	Duration of High Flow Nasal Cannula in days for enrolled subjects	Pre-treatment through 2 weeks
Secondary	Duration of Oxygenation in Days	Duration of oxygenation in days for enrolled subjects	Pre-treatment through 2 weeks
Secondary	Duration of Hospitalization in Days	Duration of hospitalization in days for enrolled subjects	Pre-treatment through 2 weeks
Secondary	Duration of PICU Stay in Days	Duration of PICU stay in days for enrolled subjects	Pre-treatment through 2 weeks