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Trial record 21 of 43 for:    "Bronchial Disease" | "Azithromycin"

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

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ClinicalTrials.gov Identifier: NCT01486758
Recruitment Status : Completed
First Posted : December 6, 2011
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Avraham Beigelman, Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition RSV Bronchiolitis
Interventions Drug: Azithromycin
Drug: Placebo
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description Placebo for 14 days. Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Period Title: Overall Study
Started 20 20
Completed 20 19
Not Completed 0 1
Reason Not Completed
Lost to Follow-up             0             1
Arm/Group Title Azithromycin Placebo Total
Hide Arm/Group Description Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. Total of all reporting groups
Overall Number of Baseline Participants 20 20 40
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
<=18 years
20
 100.0%
20
 100.0%
40
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
Female
11
  55.0%
6
  30.0%
17
  42.5%
Male
9
  45.0%
14
  70.0%
23
  57.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
8
  40.0%
7
  35.0%
15
  37.5%
White
12
  60.0%
13
  65.0%
25
  62.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 20 participants 20 participants 40 participants
20 20 40
1.Primary Outcome
Title IL-8 Concentrations
Hide Description 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.
Time Frame Day 8
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
Placebo for 14 days
Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Number of Participants Analyzed 20 19
Median (Inter-Quartile Range)
Unit of Measure: Pg/ml
12,795
(6,265 to 17,763)
14,676
(7,931 to 19,270)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
2.Primary Outcome
Title Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes
Hide Description 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.
Time Frame 3-52 weeks following randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
Placebo for 14 days.
Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: Proportion of participants
.50 .39
3.Secondary Outcome
Title Concentrations of IL-8 in Nasal Lavage on Day 15
Hide Description [Not Specified]
Time Frame Day 15
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
Placebo for 14 days.
Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Number of Participants Analyzed 20 19
Median (Inter-Quartile Range)
Unit of Measure: pg/ml
2,318
(948 to 5,476)
865
(357 to 2,212)
4.Secondary Outcome
Title Rates of Drug Related GI Side Effects.
Hide Description [Not Specified]
Time Frame One month from randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
Placebo for 14 days.
Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: Number of participants
8 7
5.Secondary Outcome
Title Likelihood to Develop 3 or More Wheezing Episodes
Hide Description Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis
Time Frame Week 3-52
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
Placebo for 14 days.
Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: percentage of participants
50 22
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Azithromycin
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.048
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
6.Secondary Outcome
Title Respiratory Symptoms Following RSV Bronchiolitis
Hide Description Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)
Time Frame 3-52 weeks following randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
Placebo for 14 days.
Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Number of Participants Analyzed 20 19
Mean (Standard Deviation)
Unit of Measure: Number of days
70.1  (43.1) 36.7  (28)
7.Secondary Outcome
Title Number of Children Who Were Prescribed Inhaled Corticosteroids
Hide Description [Not Specified]
Time Frame 3-52 weeks following randomization
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
Placebo for 14 days.
Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: Number of participants
6 1
8.Secondary Outcome
Title Proportion of Participants With a Physician Diagnosis of Asthma
Hide Description The proportion of participants with a physician diagnosis of asthma
Time Frame Week 3-52
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description:
Placebo for 14 days.
Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Overall Number of Participants Analyzed 20 19
Measure Type: Number
Unit of Measure: Percentage of participants
.25 .11
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Azithromycin
Hide Arm/Group Description Placebo for 14 days. Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
All-Cause Mortality
Placebo Azithromycin
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/20 (5.00%)      2/19 (10.53%)    
Respiratory, thoracic and mediastinal disorders     
Hospitalization for for wheezing episodes [1]  1/20 (5.00%)  3 2/19 (10.53%)  3
[1]
2 participants in the azithromycin group were re-hospitalized for wheezing episodes (3 and 11 months after enrolment) and one patient in the placebo group was hospitalized 3 times for wheezing (all within the first 3 months of the study).
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Azithromycin
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/20 (40.00%)      7/19 (36.84%)    
Gastrointestinal disorders     
Gastrointestinal adverse events [1]  8/20 (40.00%)  8 7/19 (36.84%)  7
[1]
Gastrointestinal adverse events (diarrhea, vomiting, or abdominal pain) during the treatment phase were recorded in 7 children treated with azithromycin and in 8 children treated with placebo.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Avraham Beigelman (PI)
Organization: Washington University in St. Louis
Phone: 314-454-2694
Responsible Party: Avraham Beigelman, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01486758     History of Changes
Other Study ID Numbers: 201107151
ICTS, Washington University ( Other Grant/Funding Number: CTSA402 )
First Submitted: November 28, 2011
First Posted: December 6, 2011
Results First Submitted: April 12, 2016
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017