Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children
1 other identifier
interventional
48
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2016
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 20, 2016
CompletedFirst Posted
Study publicly available on registry
March 14, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 6, 2019
CompletedResults Posted
Study results publicly available
May 27, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2020
CompletedJuly 22, 2020
July 1, 2020
3.1 years
February 20, 2016
May 8, 2020
July 7, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
Nasal Total Matrix Metalloproteinase (MMP)-9 Level
To determine the concentration of total MMP-9 levels in the nasal compartment
Day 3
Pharmacokinetic-Plasma Half Life of AZM
Measurement of AZM half life in the plasma
From baseline to 72 hours post treatment
Pharmacokinetic-Lung Half Life of AZM
Measurement of AZM half life in the lung
From baseline to 72 hours post treatment
Secondary Outcomes (6)
Duration of Mechanical Ventilation in Days
Pre-treatment through 2 weeks
Duration of BiPAP in Days
Pre-treatment through 2 weeks
Duration of High Flow Nasal Cannula in Days
Pre-treatment through 2 weeks
Duration of Oxygenation in Days
Pre-treatment through 2 weeks
Duration of Hospitalization in Days
Pre-treatment through 2 weeks
- +1 more secondary outcomes
Other Outcomes (1)
Lung Matrix Metalloproteinase (MMP) Level
Day 3
Study Arms (3)
Control
PLACEBO COMPARATORPlacebo controlled (normal saline) daily for 3 days
Azithromycin (10 mg/kg)
ACTIVE COMPARATOR10 mg/kg IV Azithromycin daily for 3 days
Azithromycin (20 mg/kg)
ACTIVE COMPARATOR20 mg/kg IV Azithromycin daily for 3 days
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UAB
Birmingham, Alabama, 35233, United States
Related Publications (1)
Kong M, Zhang WW, Sewell K, Gorman G, Kuo HC, Aban I, Ambalavanan N, Whitley RJ. Azithromycin Treatment vs Placebo in Children With Respiratory Syncytial Virus-Induced Respiratory Failure: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2020 Apr 1;3(4):e203482. doi: 10.1001/jamanetworkopen.2020.3482.
PMID: 32324238DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michele Kong, PI
- Organization
- UAB
Study Officials
- PRINCIPAL INVESTIGATOR
Michele Kong, MD
University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Participant, clinical providers and study staff are masked to the intervention. The random assignment of treatment was determined by random permutation. A statistician generated the randomization schedule and provided the randomization schedule (with randomization IDs) in an excel file to the study pharmacist in charge of dispensing the appropriate treatment.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 20, 2016
First Posted
March 14, 2016
Study Start
January 1, 2016
Primary Completion
February 6, 2019
Study Completion
June 20, 2020
Last Updated
July 22, 2020
Results First Posted
May 27, 2020
Record last verified: 2020-07