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| ID | Type | Description | Link |
|---|---|---|---|
| ICTS, Washington University | Other Grant/Funding Number | CTSA402 |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Azithromycin | Active Comparator | Oral azithromycin |
|
| Placebo | Placebo Comparator | Oral Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Azithromycin | Drug | Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 3-52 weeks following randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of IL-8 in Nasal Lavage on Day 15 | Day 15 | |
| Rates of Drug Related GI Side Effects. | One month from randomization | |
| Likelihood to Develop 3 or More Wheezing Episodes |
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Inclusion Criteria:
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
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Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Avraham Beigelman, MD, MSCI | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatrics, Washington University School of Medicine; and St. Louis Children's Hospital | St Louis | Missouri | 63110 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo for 14 days. |
| FG001 | Azithromycin | Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Azithromycin | Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. |
| BG001 | Placebo | Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Inter-Quartile Range | Pg/ml | Day 8 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo for 14 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for for wheezing episodes | Respiratory, thoracic and mediastinal disorders | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal adverse events | Gastrointestinal disorders | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Avraham Beigelman (PI) | Washington University in St. Louis | 314-454-2694 | beigelman_a@kids.wustl.edu |
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| ID | Term |
|---|---|
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 |
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| Placebo | Drug |
|
Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis |
| Week 3-52 |
| Respiratory Symptoms Following RSV Bronchiolitis | Number of days with respiratory symptoms (cough, wheeze, or shortness of breath) | 3-52 weeks following randomization |
| Number of Children Who Were Prescribed Inhaled Corticosteroids | 3-52 weeks following randomization |
| Proportion of Participants With a Physician Diagnosis of Asthma | The proportion of participants with a physician diagnosis of asthma | Week 3-52 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Counts |
|---|
| Participants |
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| Primary | 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. | Posted | Number | Proportion of participants | 3-52 weeks following randomization |
|
|
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| Secondary | Concentrations of IL-8 in Nasal Lavage on Day 15 | Posted | Median | Inter-Quartile Range | pg/ml | Day 15 |
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| Secondary | Rates of Drug Related GI Side Effects. | Posted | Number | Number of participants | One month from randomization |
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| Secondary | Likelihood to Develop 3 or More Wheezing Episodes | Likelihood to develop 3 or more wheezing episodes measured by a Kaplan-Meier survival analysis | 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. | Posted | Number | percentage of participants | Week 3-52 |
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| Secondary | Respiratory Symptoms Following RSV Bronchiolitis | Number of days with respiratory symptoms (cough, wheeze, or shortness of breath) | Posted | Mean | Standard Deviation | Number of days | 3-52 weeks following randomization |
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| Secondary | Number of Children Who Were Prescribed Inhaled Corticosteroids | Posted | Number | Number of participants | 3-52 weeks following randomization |
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| Secondary | Proportion of Participants With a Physician Diagnosis of Asthma | The proportion of participants with a physician diagnosis of asthma | Posted | Number | Percentage of participants | Week 3-52 |
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| 1 |
| 20 |
| 8 |
| 20 |
| EG001 | Azithromycin | Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days. | 2 | 19 | 7 | 19 |
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| Organic Chemicals |