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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01486758
First Posted: December 6, 2011
Last Update Posted: June 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avraham Beigelman, Washington University School of Medicine
Results First Submitted: April 12, 2016  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.

Participant Flow:   Overall Study
    Placebo   Azithromycin
STARTED   20   20 
COMPLETED   20   19 
NOT COMPLETED   0   1 
Lost to Follow-up                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Azithromycin Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Placebo Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
Total Total of all reporting groups

Baseline Measures
   Azithromycin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 20   20   40 
Age 
[Units: Participants]
Count of 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 
[Units: Participants]
Count of Participants
     
Female      11  55.0%      6  30.0%      17  42.5% 
Male      9  45.0%      14  70.0%      23  57.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   20   20   40 


  Outcome Measures
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1.  Primary:   IL-8 Concentrations   [ Time Frame: Day 8 ]

2.  Primary:   Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes   [ Time Frame: 3-52 weeks following randomization ]

3.  Secondary:   Concentrations of IL-8 in Nasal Lavage on Day 15   [ Time Frame: Day 15 ]

4.  Secondary:   Rates of Drug Related GI Side Effects.   [ Time Frame: One month from randomization ]

5.  Secondary:   Likelihood to Develop 3 or More Wheezing Episodes   [ Time Frame: Week 3-52 ]

6.  Secondary:   Respiratory Symptoms Following RSV Bronchiolitis   [ Time Frame: 3-52 weeks following randomization ]

7.  Secondary:   Number of Children Who Were Prescribed Inhaled Corticosteroids   [ Time Frame: 3-52 weeks following randomization ]

8.  Secondary:   Proportion of Participants With a Physician Diagnosis of Asthma   [ Time Frame: Week 3-52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: beigelman_a@kids.wustl.edu



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