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Trial record 21 of 44 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

Tracking Information
First Submitted Date  ICMJE November 28, 2011
First Posted Date  ICMJE December 6, 2011
Results First Submitted Date  ICMJE April 12, 2016
Results First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Study Start Date  ICMJE December 2011
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2011)
  • IL-8 Concentrations [ Time Frame: 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.
  • Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01486758 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 15, 2017)
  • Concentrations of IL-8 in Nasal Lavage on Day 15 [ Time Frame: Day 15 ]
  • Rates of Drug Related GI Side Effects. [ Time Frame: One month from randomization ]
  • Likelihood to Develop 3 or More Wheezing Episodes [ Time Frame: Week 3-52 ]
    Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis
  • Respiratory Symptoms Following RSV Bronchiolitis [ Time Frame: 3-52 weeks following randomization ]
    Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)
  • Number of Children Who Were Prescribed Inhaled Corticosteroids [ Time Frame: 3-52 weeks following randomization ]
  • Proportion of Participants With a Physician Diagnosis of Asthma [ Time Frame: Week 3-52 ]
    The proportion of participants with a physician diagnosis of asthma
Original Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2011)
  • Concentrations of inflammatory mediators in nasal lavage and serum measured on day 8, 15 (nasal lavage only) from randomization. [ Time Frame: 8, 15 days ]
    Inflammatory mediators: IL-8, CCL-2, CCL-3, CCL-4, CCL-5, G-CSF, IL-4, , IL-10, IL-12, IL-13. In addition, concentrations of the above cytokines in nasal lavage on day 8 and 15 from randomization once corrected to the corresponding IL-2 level (i.e., target cytokine/IL-2).
  • Rates of drug related side effects. [ Time Frame: One month from randomization ]
  • Clinical severity of acute bronchiolitis [ Time Frame: During the acute hospitalization: expected lenght of hospitalization is 3 days ]
    Length of hospitalization (hr), duration of supplemental oxygen (hr), duration of supplemental IV fluids (hr).
  • Respiratory Symptoms (and treatments) following RSV bronchiolitis [ Time Frame: 3-52 weeks following randomization ]
    1. Proportion of children with one and 3 wheezing episode; time to 1st, 2nd and 3rd episodes of wheezing
    2. Number of: a) wheezing episodes, b) days/nights with wheezing/cough, c) days with use of rescue albuterol, d) courses of oral corticosteroids and antibiotics, e) MD/ED visits and hospitalizations for respiratory symptoms, and f) days with parental absence from work and infant absence from day care, g) days/nights with respiratory symptoms.
  • Asthma Dx [ Time Frame: 3-52 weeks following randomization ]
    1. Proportion of children with physician diagnosis of asthma.
    2. Proportion of children who were prescribed asthma controllers medications (inhales corticosteroids and/or montelukast) during 52 weeks post-randomization.
  • Quality of life [ Time Frame: 52 weeks following randomization ]
    Quality of life measured by Quality of Life questionnaire
  • Atopy [ Time Frame: 52 weeks following randomization ]
    1. Proportion of children with at least one positive specific IgE (SIgE) to inhalant or food allergens at the end of study visit. We will measure the concentrations of SIgE to the following allergens: cat, dog, mite, rat, cockroach, mold mix, tree mix, grass mix, weed mix, cow's milk, egg white and peanut using the ImunoCAP platform (Phadia).
    2. Mean total IgE level and eosinophil count.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
Official Title  ICMJE Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis
Brief Summary

This trial is a proof-of-concept pilot study aim to investigate the biologic and clinical effects of early azithromycin treatment in children hospitalized with Respiratory Syncytial Virus (RSV) bronchiolitis.

HYPOTHESES

In infants hospitalized with RSV bronchiolitis, azithromycin therapy (compared to placebo) will result in:

  1. Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.
  2. A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE RSV Bronchiolitis
Intervention  ICMJE
  • Drug: Azithromycin
    Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
  • Drug: Placebo
Study Arms  ICMJE
  • Active Comparator: Azithromycin
    Oral azithromycin
    Intervention: Drug: Azithromycin
  • Placebo Comparator: Placebo
    Oral Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 4, 2011)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age: 1-18 months.
  2. Hospitalization for the first episode of RSV bronchiolitis:

    • Confirmed RSV infection by positive nasal swab results (viral culture and/or direct antigen detection) from the SLCH virology lab; AND
    • At least two of the following symptoms/signs of bronchiolitis: respiratory rate greater than 40 breaths/minute; cough; wheezing; audible rales, crackles, and/or rhonchi; paradoxical chest movements (retractions).
  3. Duration of respiratory symptoms from initiation of symptoms to admission is 5 days or less. Time of admission will define by the time the child was seen in the ED for the visit that led to hospitalization.
  4. Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).
  5. Willingness to provide informed consent by the child's parent or guardian

    -

Exclusion Criteria:

  1. Prematurity (gestational age < 36 weeks).
  2. Presence or history of other significant disease (CNS, lung, cardiac, renal, GI, hepatic disease, hematologic, endocrine or immune disease). Children with atopic dermatitis will not be excluded from the study.
  3. Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
  4. The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
  5. History of previous (before the current episode) wheeze or previous treatment with albuterol.
  6. Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast.
  7. Treatment with any antibiotics in the past 2 weeks.
  8. Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks.
  9. Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements).
  10. Participation in another clinical trial.
  11. Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.
  12. Contraindication of use of azithromycin or any other macrolide antibiotics.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Month to 18 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01486758
Other Study ID Numbers  ICMJE 201107151
ICTS, Washington University ( Other Grant/Funding Number: CTSA402 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Avraham Beigelman, Washington University School of Medicine
Study Sponsor  ICMJE Washington University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Avraham Beigelman, MD, MSCI Washington University School of Medicine
PRS Account Washington University School of Medicine
Verification Date May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP