RSV BronchiolitisPhase 2APW-RSVNCT01486758
Azithromycin to Prevent Wheezing Following Severe Respiratory Syncytial Virus (RSV) Bronchiolitis
A Phase 2 study testing Azithromycin in people with RSV Bronchiolitis, run by Washington University School of Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 months
- Conditions the study is for
- RSV Bronchiolitis
- What is being tested?
- Azithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to May 2014
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age: 1-18 months.
- 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).
- 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.
- Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).
- Willingness to provide informed consent by the child's parent or guardian
- -
Who cannot join
- Prematurity (gestational age < 36 weeks).
- 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.
- Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
- The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
- History of previous (before the current episode) wheeze or previous treatment with albuterol.
- Treatment (past of present) with corticosteroid (systemic or inhaled) and/or montelukast.
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- Treatment with any antibiotics in the past 2 weeks.
- Treatment with Macrolide antibiotic (Azithromycin, clarithromycin or erythromycin) with the past 4 weeks.
- Current treatment with any daily medication (other then albuterol, vitamins or nutritional supplements).
- Participation in another clinical trial.
- Evidence that the family may be unreliable or nonadherent, or may move from the clinical center area before trial completion.
- Contraindication of use of azithromycin or any other macrolide antibiotics.
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital
St Louis, Missouri, 63110
About this study
Official title: Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis
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:
- Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.
- A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.
- Conditions
- RSV Bronchiolitis
- Being tested
- Azithromycin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin | Active comparator | Oral azithromycin Receives: Drug: Azithromycin |
| Placebo | Placebo comparator | Oral Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 8
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.
Measured: 3-52 weeks following randomization
Secondary outcomes (6)
Concentrations of IL-8 in Nasal Lavage on Day 15
Measured: Day 15
Rates of Drug Related GI Side Effects.
Measured: One month from randomization
Likelihood to Develop 3 or More Wheezing Episodes
Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis
Measured: Week 3-52
Respiratory Symptoms Following RSV Bronchiolitis
Number of days with respiratory symptoms (cough, wheeze, or shortness of breath)
Measured: 3-52 weeks following randomization
Number of Children Who Were Prescribed Inhaled Corticosteroids
Measured: 3-52 weeks following randomization
Proportion of Participants With a Physician Diagnosis of Asthma
The proportion of participants with a physician diagnosis of asthma
Measured: Week 3-52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for RSV BronchiolitisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Avraham Beigelman, Washington University School of Medicine
- Investigators
- Avraham Beigelman, MD, MSCI, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01486758
- Sponsor's protocol ID
- 201107151
- Other IDs
- ICTS, Washington University
- Acronym
- APW-RSV
- Status last verified
- May 2017
- First submitted
- 28 Nov 2011
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Azithromycin to Prevent Wheezing Following Severe RSV Bronchiolitis
- ClinicalTrials.gov ID
- NCT01486758
- Acronym / sponsor ID
- APW-RSV / 201107151
- Conditions
- RSV Bronchiolitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Dec 2011 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Decreased concentrations of inflammatory mediators (IL-8 as primary outcome) in serum and nasal wash measured on day 8 after randomization.
- A smaller proportion of participants with recurrent (≥2) wheezing episodes during weeks 3-52 following randomization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Azithromycin | Active comparator | Drug: AzithromycinOral azithromycin |
| Placebo | Placebo comparator | Drug: PlaceboOral Placebo |
Who may qualify
- Ages
- 1 month to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age: 1-18 months.
- Hospitalization for the first episode of RSV bronchiolitis:
- 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.
- Randomization can be performed within 48 hours from time of admission (defined by time of first set of vital signs obtained on the floor).
- Willingness to provide informed consent by the child's parent or guardian
Key exclusion criteria (12 listed)
- Prematurity (gestational age < 36 weeks).
- 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.
- Clinically significant gastroesophageal reflux currently treated with a daily anti-reflux medication (anti- H2 or PPI).
- The child has significant developmental delay/failure to thrive, defined as weight < 3% for age and gender.
- History of previous (before the current episode) wheeze or previous treatment with albuterol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AzithromycinOral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. | Drug | Azithromycin |
| Placebo | Drug | Placebo |
Primary outcome
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.
6 secondary outcomes
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
Respiratory Symptoms Following RSV Bronchiolitis
Time frame: 3-52 weeks following randomization
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avraham Beigelman, MD, MSCI principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Azithromycin in people with RSV Bronchiolitis, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IL-8 Concentrations (time frame: Day 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.