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

The University of Alabama at Birmingham

Status and phase: Completed; Phase 2

Conditions: Respiratory Syncytial Virus

Treatments: Drug: Placebo; Drug: Azithromycin 20mg; Drug: Azithromycin 10 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT02707523

FWA00005960

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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48 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

Placebo controlled (normal saline) daily for 3 days

Treatment:

Drug: Placebo

Azithromycin (10 mg/kg)

Active Comparator group

Description:

10 mg/kg IV Azithromycin daily for 3 days

Treatment:

Drug: Azithromycin 10 mg

Azithromycin (20 mg/kg)

Active Comparator group

Description:

20 mg/kg IV Azithromycin daily for 3 days

Treatment:

Drug: Azithromycin 20mg