Trial Outcomes & Findings for Azithromycin for Children Hospitalized With Asthma (NCT NCT02003911)
NCT ID: NCT02003911
Last Updated: 2020-08-13
Results Overview
Hospital length of stay
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
159 participants
Primary outcome timeframe
Admission time to discharge time (average LOS is 3 days)
Results posted on
2020-08-13
Participant Flow
Participant milestones
| Measure |
Azithromycin Suspension
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
80
|
79
|
|
Overall Study
COMPLETED
|
78
|
72
|
|
Overall Study
NOT COMPLETED
|
2
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Azithromycin for Children Hospitalized With Asthma
Baseline characteristics by cohort
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
Total
n=159 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.5 years
n=5 Participants
|
7.1 years
n=7 Participants
|
7.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
55 Participants
n=5 Participants
|
56 Participants
n=7 Participants
|
111 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
40 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
PASS Score on enrollment
|
2.35 Score on a scale
STANDARD_DEVIATION 1.25 • n=5 Participants
|
2.71 Score on a scale
STANDARD_DEVIATION 1.29 • n=7 Participants
|
2.53 Score on a scale
STANDARD_DEVIATION 1.28 • n=5 Participants
|
PRIMARY outcome
Timeframe: Admission time to discharge time (average LOS is 3 days)Hospital length of stay
Outcome measures
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Length of Stay
|
1.69 days
Interval 1.33 to 2.48
|
1.86 days
Interval 1.33 to 2.63
|
SECONDARY outcome
Timeframe: One month after dischargeNumber of hospital readmissions for asthma at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Outcome measures
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Readmission Rate
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: One month after dischargeDays of school missed by patient at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Outcome measures
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
School Missed
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One month after dischargeDays of work missed by parent/guardian at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Outcome measures
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Work Missed
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: One month after dischargeNumber of emergency room visits for asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Outcome measures
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Emergency Room Visits
|
6 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: One month after dischargeNumber of physician office visits for asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Outcome measures
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Physician Office Visits
|
7 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: One month after dischargeNumber of recurrences of asthma symptoms since discharge at telephone follow-up phone calls at 1-week and 1-month interval after discharge
Outcome measures
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Recurrence of Asthma Symptoms
|
18 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: One month after dischargeNumber of courses of oral steroids since discharge at telephone follow-up phone call 1-month after discharge
Outcome measures
| Measure |
Azithromycin Suspension
n=80 Participants
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 Participants
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Steroid Courses
|
8 Participants
|
11 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: One week after dischargeRespiratory viral panel or rapid viral testing results (if obtained as part of medical care), chest x-ray results/lab results (if obtained as part of medical care), vital signs, medications received during admission, medication side effects (diarrhea, abdominal pain, vomiting, flatulence), transfer to intensive care unit, time of wean of beta-agonists (q3h and q4h), and asthma severity (PASS score) at time of enrollment.
Outcome measures
Outcome data not reported
Adverse Events
Azithromycin Suspension
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Suspension
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azithromycin Suspension
n=80 participants at risk
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 participants at risk
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Transfer to PICU
|
0.00%
0/80 • One month
|
1.3%
1/79 • Number of events 1 • One month
|
Other adverse events
| Measure |
Azithromycin Suspension
n=80 participants at risk
Azithromycin suspension at 10mg/kg/dose (max 500mg)
Once daily for 3 days
Azithromycin: Azithromycin suspension (200mg/5mL)
|
Placebo Suspension
n=79 participants at risk
Same volume as active drug
Once daily for 3 days
Placebo
|
|---|---|---|
|
Social circumstances
Study Exit
|
2.5%
2/80 • Number of events 2 • One month
|
8.9%
7/79 • Number of events 7 • One month
|
Additional Information
Dr. Lindsey Douglas
Mount Sinai Kravis Children's Hospital
Phone: 2122416500
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place