NCT02707523

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

Completed Phase 2 Results posted Last updated 22 July 2020

What this trial tests

Phase 2 trial testing Azithromycin 10 mg in Respiratory Syncytial Virus in 48 participants. Completed in 20 June 2020.

Timeline

1 January 2016

Primary endpoint
6 February 2019

20 June 2020

Quick facts

Lead sponsor	University of Alabama at Birmingham
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	sequential
Masking	quadruple
Primary purpose	treatment
Enrollment	48
Start date	1 January 2016
Primary completion	6 February 2019
Estimated completion	20 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Azithromycin 10 mg — full drug profile →
• Azithromycin 20mg — full drug profile →
• Placebo

Conditions studied

• Respiratory Syncytial Virus — all drugs for Respiratory Syncytial Virus →

Sponsor

University of Alabama at Birmingham

Who can join

Under 16, any sex, with Respiratory Syncytial Virus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Primary · Baseline through Day 3

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

Group	Value	95% CI
Control	0
Azithromycin (10 mg/kg)	0
Azithromycin (20 mg/kg)	0

Nasal Total Matrix Metalloproteinase (MMP)-9 Level Primary · Day 3

To determine the concentration of total MMP-9 levels in the nasal compartment

Group	Value	95% CI
Control	545	± 708
Azithromycin (10 mg/kg)	267	± 301
Azithromycin (20 mg/kg)	413	± 814

Pharmacokinetic-Plasma Half Life of AZM Primary · From baseline to 72 hours post treatment

Measurement of AZM half life in the plasma

Group	Value	95% CI
Control	0	± 0
Azithromycin (10 mg/kg)	76	± 17
Azithromycin (20 mg/kg)	102	± 33

Pharmacokinetic-Lung Half Life of AZM Primary · From baseline to 72 hours post treatment

Measurement of AZM half life in the lung

Group	Value	95% CI
Control	0	± 0
Azithromycin (10 mg/kg)	78	± 31
Azithromycin (20 mg/kg)	385	± 63

Duration of Mechanical Ventilation in Days Secondary · Pre-treatment through 2 weeks

Duration of mechanical ventilation in days for enrolled subjects

Group	Value	95% CI
Control	4.8	± 3.4
Azithromycin (10 mg/kg)	5.6	± 5.5
Azithromycin (20 mg/kg)	2.6	± 2.8

Duration of BiPAP in Days Secondary · Pre-treatment through 2 weeks

Duration of BiPAP in days for enrolled subjects

Group	Value	95% CI
Control	3.6	± 13.2
Azithromycin (10 mg/kg)	0.4	± 1.5
Azithromycin (20 mg/kg)	0.1	± 0.3

Duration of High Flow Nasal Cannula in Days Secondary · Pre-treatment through 2 weeks

Duration of High Flow Nasal Cannula in days for enrolled subjects

Group	Value	95% CI
Control	3.3	± 4.9
Azithromycin (10 mg/kg)	2.4	± 2
Azithromycin (20 mg/kg)	2.3	± 1.7

Duration of Oxygenation in Days Secondary · Pre-treatment through 2 weeks

Duration of oxygenation in days for enrolled subjects

Group	Value	95% CI
Control	11	± 8.7
Azithromycin (10 mg/kg)	9.6	± 5.8
Azithromycin (20 mg/kg)	6.6	± 4

Duration of Hospitalization in Days Secondary · Pre-treatment through 2 weeks

Duration of hospitalization in days for enrolled subjects

Group	Value	95% CI
Control	15.8	± 13.1
Azithromycin (10 mg/kg)	11.8	± 6.5
Azithromycin (20 mg/kg)	9.1	± 4.7

Duration of PICU Stay in Days Secondary · Pre-treatment through 2 weeks

Duration of PICU stay in days for enrolled subjects

Group	Value	95% CI
Control	7.7	± 4.4
Azithromycin (10 mg/kg)	8.1	± 5.8
Azithromycin (20 mg/kg)	5.4	± 2.7

Lung Matrix Metalloproteinase (MMP) Level Secondary · Day 3

To determine the concentration of MMP-9 levels in the lung compartment

Group	Value	95% CI
Control	13743	± 23831
Azithromycin (10 mg/kg)	1448	± 1478
Azithromycin (20 mg/kg)	1908	± 2588

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Azithromycin Treatment vs Placebo in Children With Respiratory Syncytial Virus-Induced Respiratory Failure: A Phase 2 Randomized Clinical Trial.
   Kong M, Zhang WW, Sewell K, Gorman G, et al · · 2020 · cited 14× · PMID 32324238 · DOI 10.1001/jamanetworkopen.2020.3482