Trial · NCT02707523

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

NCT02707523, Phase 2, Completed, University of Alabama at Birmingham; results first posted 2020-05-27

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children. Trials, record NCT02707523. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02707523

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prospective Pilot Clinical Trial of Azithromycin Treatment In Respiratory Syncytial Virus (RSV)- Induced Respiratory Failure In Children
NCT number: NCT02707523
Status: Completed
Phases: Phase 2
Enrollment: 48 participants, actual
Lead sponsor: University of Alabama at Birmingham
Conditions: Respiratory Syncytial Virus
Interventions: Azithromycin 10 mg, Azithromycin 20mg, Placebo
First posted: 2016-03-14
Last updated: 2020-07-22
Results first posted: 2020-05-27

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	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
Primary	Nasal Total Matrix Metalloproteinase (MMP)-9 Level	Day 3	To determine the concentration of total MMP-9 levels in the nasal compartment
Primary	Pharmacokinetic-Plasma Half Life of AZM	From baseline to 72 hours post treatment	Measurement of AZM half life in the plasma
Primary	Pharmacokinetic-Lung Half Life of AZM	From baseline to 72 hours post treatment	Measurement of AZM half life in the lung
Secondary	Duration of Mechanical Ventilation in Days	Pre-treatment through 2 weeks	Duration of mechanical ventilation in days for enrolled subjects
Secondary	Duration of BiPAP in Days	Pre-treatment through 2 weeks	Duration of BiPAP in days for enrolled subjects
Secondary	Duration of High Flow Nasal Cannula in Days	Pre-treatment through 2 weeks	Duration of High Flow Nasal Cannula in days for enrolled subjects
Secondary	Duration of Oxygenation in Days	Pre-treatment through 2 weeks	Duration of oxygenation in days for enrolled subjects
Secondary	Duration of Hospitalization in Days	Pre-treatment through 2 weeks	Duration of hospitalization in days for enrolled subjects
Secondary	Duration of PICU Stay in Days	Pre-treatment through 2 weeks	Duration of PICU stay in days for enrolled subjects

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Baseline through Day 3	participants	NUMBER
PRIMARY	Nasal Total Matrix Metalloproteinase (MMP)-9 Level	Day 3	ng/ml	MEAN
PRIMARY	Pharmacokinetic-Plasma Half Life of AZM	From baseline to 72 hours post treatment	hours	MEAN
PRIMARY	Pharmacokinetic-Lung Half Life of AZM	From baseline to 72 hours post treatment	hours	MEAN
SECONDARY	Duration of Mechanical Ventilation in Days	Pre-treatment through 2 weeks	Days	MEAN
SECONDARY	Duration of BiPAP in Days	Pre-treatment through 2 weeks	days	MEAN
SECONDARY	Duration of High Flow Nasal Cannula in Days	Pre-treatment through 2 weeks	Days	MEAN
SECONDARY	Duration of Oxygenation in Days	Pre-treatment through 2 weeks	days	MEAN
SECONDARY	Duration of Hospitalization in Days	Pre-treatment through 2 weeks	days	MEAN
SECONDARY	Duration of PICU Stay in Days	Pre-treatment through 2 weeks	days	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group33

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Control	0		participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Azithromycin (10 mg/kg)	0		participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0	Azithromycin (20 mg/kg)	0		participants
Nasal Total Matrix Metalloproteinase (MMP)-9 Level	Control	545	Standard Deviation 708	ng/ml
Nasal Total Matrix Metalloproteinase (MMP)-9 Level	Azithromycin (10 mg/kg)	267	Standard Deviation 301	ng/ml
Nasal Total Matrix Metalloproteinase (MMP)-9 Level	Azithromycin (20 mg/kg)	413	Standard Deviation 814	ng/ml
Pharmacokinetic-Plasma Half Life of AZM	Control	0	Standard Deviation 0	hours
Pharmacokinetic-Plasma Half Life of AZM	Azithromycin (10 mg/kg)	76	Standard Deviation 17	hours
Pharmacokinetic-Plasma Half Life of AZM	Azithromycin (20 mg/kg)	102	Standard Deviation 33	hours
Pharmacokinetic-Lung Half Life of AZM	Control	0	Standard Deviation 0	hours

1 to 10 of 33Source ClinicalTrials.gov

See all 33 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Control	16
Overall Study	STARTED	Azithromycin (10 mg/kg)	16
Overall Study	STARTED	Azithromycin (20 mg/kg)	16
Overall Study	COMPLETED	Control	16
Overall Study	COMPLETED	Azithromycin (10 mg/kg)	16
Overall Study	COMPLETED	Azithromycin (20 mg/kg)	16
Overall Study	NOT COMPLETED	Control	0
Overall Study	NOT COMPLETED	Azithromycin (10 mg/kg)	0
Overall Study	NOT COMPLETED	Azithromycin (20 mg/kg)	0

Source ClinicalTrials.gov

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals9

The totals the trial posted for each group.

Total	Group	At risk
Total, all-cause mortality	Control	16
Total, all-cause mortality	Azithromycin (10 mg/kg)	16
Total, all-cause mortality	Azithromycin (20 mg/kg)	16
Total, other adverse events	Control	16
Total, other adverse events	Azithromycin (10 mg/kg)	16
Total, other adverse events	Azithromycin (20 mg/kg)	16
Total, serious adverse events	Control	16
Total, serious adverse events	Azithromycin (10 mg/kg)	16
Total, serious adverse events	Azithromycin (20 mg/kg)	16

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
32324238	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02707523

GET https://conductscience.org/api/trials/v1/NCT02707523/results?page=2

API reference For AI assistants