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CompletedNCT01486758APW-RSVUpdated Jun 14, 2017Results posted

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

A Phase 2 interventional study of Azithromycin and Placebo in RSV Bronchiolitis, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 1 Month to 18 Months. Per ClinicalTrials.gov, last updated 2017-06-14.

Sponsored by Washington University School of Medicine · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
1 Month to 18 Months
Sex
All
01

Study 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.
02

Conditions studied

  • RSV Bronchiolitis
03

In context

Bronchiolitis

360 studies on the registry are indexed under Bronchiolitis; 43 are open to participants now.

This study's enrollment of 40 is below the median of 80 across 249 interventional studies indexed under Bronchiolitis.

Browse Bronchiolitis studies →

Lead sponsor

Washington University School of Medicine is the lead sponsor of 1,764 studies on the registry; 270 are open to participants now.

Of its 325 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 18 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

-

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Active comparator
    Azithromycin

    Oral azithromycin

    Drug: Azithromycin

  • Placebo comparator
    Placebo

    Oral Placebo

    Drug: Placebo

Interventions

  • DrugAzithromycin

    Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.

  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. IL-8 Concentrations

    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

  2. Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes

    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

Secondary outcomes

  1. Concentrations of IL-8 in Nasal Lavage on Day 15

    Time frame: Day 15

  2. Rates of Drug Related GI Side Effects.

    Time frame: One month from randomization

  3. Likelihood to Develop 3 or More Wheezing Episodes

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

    Time frame: Week 3-52

  4. Respiratory Symptoms Following RSV Bronchiolitis

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

    Time frame: 3-52 weeks following randomization

  5. Number of Children Who Were Prescribed Inhaled Corticosteroids

    Time frame: 3-52 weeks following randomization

  6. Proportion of Participants With a Physician Diagnosis of Asthma

    The proportion of participants with a physician diagnosis of asthma

    Time frame: Week 3-52

07

Results

Posted Jun 14, 2017

Participant flow

Participant flow — Overall Study
MilestonePlaceboAzithromycin
Started2020
Completed2019
Not completed01
Withdrew: Lost to follow-up01

Outcome measures

PrimaryIL-8 Concentrations

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
Reported as:
Median · Pg/ml
IL-8 Concentrations
Pg/mlPlaceboAzithromycin
IL-8 Concentrations12,795 (6,265 to 17,763)14,676 (7,931 to 19,270)
Statistical analysis
  • Placebo vs Azithromycin · ANCOVA · p = 0.6
PrimaryProportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes

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
Reported as:
Number · Proportion of participants
Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes
Proportion of participantsPlaceboAzithromycin
Proportion of Participants Who Experience Subsequent Recurrent (≥2) Wheezing Episodes.50.39
SecondaryConcentrations of IL-8 in Nasal Lavage on Day 15
Time frame:
Day 15
Reported as:
Median · pg/ml
Concentrations of IL-8 in Nasal Lavage on Day 15
pg/mlPlaceboAzithromycin
Concentrations of IL-8 in Nasal Lavage on Day 152,318 (948 to 5,476)865 (357 to 2,212)
SecondaryRates of Drug Related GI Side Effects.
Time frame:
One month from randomization
Reported as:
Number · Number of participants
Rates of Drug Related GI Side Effects.
Number of participantsPlaceboAzithromycin
Rates of Drug Related GI Side Effects.87
SecondaryLikelihood to Develop 3 or More Wheezing Episodes

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

Time frame:
Week 3-52
Reported as:
Number · percentage of participants
Likelihood to Develop 3 or More Wheezing Episodes
percentage of participantsPlaceboAzithromycin
Likelihood to Develop 3 or More Wheezing Episodes5022
Statistical analysis
  • Placebo vs Azithromycin · Log Rank · p = 0.048
SecondaryRespiratory Symptoms Following RSV Bronchiolitis

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

Time frame:
3-52 weeks following randomization
Reported as:
Mean · Number of days
Respiratory Symptoms Following RSV Bronchiolitis
Number of daysPlaceboAzithromycin
Respiratory Symptoms Following RSV Bronchiolitis70.1 ± 43.136.7 ± 28
SecondaryNumber of Children Who Were Prescribed Inhaled Corticosteroids
Time frame:
3-52 weeks following randomization
Reported as:
Number · Number of participants
Number of Children Who Were Prescribed Inhaled Corticosteroids
Number of participantsPlaceboAzithromycin
Number of Children Who Were Prescribed Inhaled Corticosteroids61
SecondaryProportion of Participants With a Physician Diagnosis of Asthma

The proportion of participants with a physician diagnosis of asthma

Time frame:
Week 3-52
Reported as:
Number · Percentage of participants
Proportion of Participants With a Physician Diagnosis of Asthma
Percentage of participantsPlaceboAzithromycin
Proportion of Participants With a Physician Diagnosis of Asthma.25.11

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo—1/20 (5%)8/20 (40%)
Azithromycin—2/19 (10.5%)7/19 (36.8%)
Most frequent serious events
Most frequent serious events
EventPlaceboAzithromycin
Hospitalization for for wheezing episodesRespiratory, thoracic and mediastinal disorders1/202/19
Most frequent other events
Most frequent other events
EventPlaceboAzithromycin
Gastrointestinal adverse eventsGastrointestinal disorders8/207/19

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)AzithromycinPlaceboTotal
<=18 years202040
Between 18 and 65 years000
>=65 years000
Sex: Female, Male
Sex: Female, Male(Participants)AzithromycinPlaceboTotal
Female11617
Male91423
Race (NIH/OMB)
Race (NIH/OMB)(Participants)AzithromycinPlaceboTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American8715
White121325
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)AzithromycinPlaceboTotal
United States202040
08

Study locations

1 site
  • Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital
    Saint Louis, Missouri 63110, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 14, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01486758
Lead sponsor
Washington University School of Medicine
Responsible party
Avraham Beigelman (Assistant Professor of Pediatrics, Washington University School of Medicine) — Principal investigator
First posted
Dec 6, 2011
Start date
Dec 2011
Primary completion
Apr 2014
Completion
May 2014
Results posted
Jun 14, 2017
Last update
Jun 14, 2017

Study contacts

Avraham Beigelman, MD, MSCI
principal investigator · Washington University School of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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