Trial Outcomes & Findings for Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis (NCT NCT01486758)

NCT ID: NCT01486758

Last Updated: 2017-06-14

Results Overview

Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: Day 8
• Results posted on: 2017-06-14

Participant Flow

Participant milestones

Measure	Placebo Placebo for 14 days.	Azithromycin Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	19
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Placebo Placebo for 14 days.	Azithromycin Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis

Baseline characteristics by cohort

Measure	Azithromycin n=20 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.	Placebo n=20 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	6 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 8

Biological outcome: The difference in IL-8 concentrations, measured in serum on day 8 after randomization, among infants treated with azithromycin and those treated with placebo.

Outcome measures

Measure	Placebo n=20 Participants Placebo for 14 days	Azithromycin n=19 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
IL-8 Concentrations	12,795 Pg/ml	14,676 Pg/ml

PRIMARY outcome

Timeframe: 3-52 weeks following randomization

Clinical outcome: The difference in the proportion of participants who experience subsequent recurrent (≥2) wheezing episodes among infants treated with azithromycin and those treated with placebo.

Outcome measures

Measure	Placebo n=20 Participants Placebo for 14 days	Azithromycin n=19 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes	.50 Proportion of participants	.39 Proportion of participants

SECONDARY outcome

Timeframe: Day 15

Outcome measures

Measure	Placebo n=20 Participants Placebo for 14 days	Azithromycin n=19 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Concentrations of IL-8 in Nasal Lavage on Day 15	2,318 pg/ml Interval 948.0 to	865 pg/ml Interval 357.0 to

SECONDARY outcome

Timeframe: One month from randomization

Outcome measures

Measure	Placebo n=20 Participants Placebo for 14 days	Azithromycin n=19 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Rates of Drug Related GI Side Effects.	8 Number of participants	7 Number of participants

SECONDARY outcome

Timeframe: Week 3-52

Population: A Kaplan-Meier survival analysis was conducted to compare the likelihood of developing a third episode of wheezing among participants who received azithromycin versus those who received placebo.

Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis

Outcome measures

Measure	Placebo n=20 Participants Placebo for 14 days	Azithromycin n=19 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Likelihood to Develop 3 or More Wheezing Episodes	50 percentage of participants	22 percentage of participants

SECONDARY outcome

Timeframe: 3-52 weeks following randomization

Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)

Outcome measures

Measure	Placebo n=20 Participants Placebo for 14 days	Azithromycin n=19 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Respiratory Symptoms Following RSV Bronchiolitis	70.1 Number of days Standard Deviation 43.1	36.7 Number of days Standard Deviation 28

SECONDARY outcome

Timeframe: 3-52 weeks following randomization

Outcome measures

Measure	Placebo n=20 Participants Placebo for 14 days	Azithromycin n=19 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Number of Children Who Were Prescribed Inhaled Corticosteroids	6 Number of participants	1 Number of participants

SECONDARY outcome

Timeframe: Week 3-52

The proportion of participants with a physician diagnosis of asthma

Outcome measures

Measure	Placebo n=20 Participants Placebo for 14 days	Azithromycin n=19 Participants Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Proportion of Participants With a Physician Diagnosis of Asthma	.25 Percentage of participants	.11 Percentage of participants

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 8 other events

Deaths: 0 deaths

Azithromycin

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Placebo n=20 participants at risk Placebo for 14 days.	Azithromycin n=19 participants at risk Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Respiratory, thoracic and mediastinal disorders Hospitalization for for wheezing episodes	5.0% 1/20 • Number of events 3	10.5% 2/19 • Number of events 3

Other adverse events

Measure	Placebo n=20 participants at risk Placebo for 14 days.	Azithromycin n=19 participants at risk Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Gastrointestinal disorders Gastrointestinal adverse events	40.0% 8/20 • Number of events 8	36.8% 7/19 • Number of events 7

Additional Information

Dr. Avraham Beigelman (PI)

Washington University in St. Louis

Phone: 314-454-2694

Email: beigelman_a@kids.wustl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place