Trial Outcomes & Findings for Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients (NCT NCT02036840)
NCT ID: NCT02036840
Last Updated: 2015-04-22
Results Overview
Recruitment status
COMPLETED
Target enrollment
513 participants
Primary outcome timeframe
24 hours
Results posted on
2015-04-22
Participant Flow
Participant milestones
| Measure |
Penicillin Allergy
Antibiotic
|
|---|---|
|
Overall Study
STARTED
|
513
|
|
Overall Study
COMPLETED
|
513
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Antibiotic Choices for Surgical Prophylaxis in Penicillin-allergic Pediatric Patients
Baseline characteristics by cohort
| Measure |
Penicillin Allergy
n=513 Participants
Antibiotic
|
|---|---|
|
Age, Categorical
<=18 years
|
513 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
250 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
263 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
513 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursOutcome measures
| Measure |
Penicillin Allergy
n=513 Participants
Antibiotic
|
|---|---|
|
Number of Subjects With Antibiotic Related Adverse Event
|
12 participants
|
Adverse Events
Penicillin Allergy
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Penicillin Allergy
n=513 participants at risk
Antibiotic
|
|---|---|
|
Immune system disorders
Hives
|
0.78%
4/513
Please note: This is a retrospective chart review so the antibiotic related adverse events listed below occurred before the study even started.
|
|
Immune system disorders
Erythema
|
0.19%
1/513
Please note: This is a retrospective chart review so the antibiotic related adverse events listed below occurred before the study even started.
|
|
Immune system disorders
Rash
|
1.2%
6/513
Please note: This is a retrospective chart review so the antibiotic related adverse events listed below occurred before the study even started.
|
|
General disorders
Hypotension
|
0.19%
1/513
Please note: This is a retrospective chart review so the antibiotic related adverse events listed below occurred before the study even started.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place