Trial Outcomes & Findings for Penicillin De-labeling in the Pediatric Primary Care Setting (NCT NCT05010304)

NCT ID: NCT05010304

Last Updated: 2024-08-14

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

23 participants

Primary outcome timeframe

Day 1

Results posted on

2024-08-14

Participant Flow

Participant milestones

Participant milestones
Measure	Pediatric Patients With a History of Penicillin Allergy Amoxicillin: Two-dose amoxicillin challenge
Overall Study STARTED	23
Overall Study COMPLETED	23
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Penicillin De-labeling in the Pediatric Primary Care Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Pediatric Patients With a History of Penicillin Allergy n=23 Participants Amoxicillin: Two-dose amoxicillin challenge
Age, Continuous	9.3 years STANDARD_DEVIATION 0.8 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	10 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	11 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	8 Participants n=99 Participants
Race (NIH/OMB) White	14 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	23 participants n=99 Participants

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Pediatric Patients With a History of Penicillin Allergy n=23 Participants Amoxicillin: Two-dose amoxicillin challenge
Subjects Who Complete Risk-stratification of Penicillin Allergy in the Pediatric Primary Care Setting	23 Participants

PRIMARY outcome

Timeframe: Day 1

Outcome measures

Outcome measures
Measure	Pediatric Patients With a History of Penicillin Allergy n=23 Participants Amoxicillin: Two-dose amoxicillin challenge
Subjects Stratified as Low-risk With a Negative Immediate Amoxicillin Challenge in the Pediatric Primary Care Setting	21 Participants

SECONDARY outcome

Timeframe: 10-14 months after amoxicillin challenge

Subjects who have a penicillin allergy label added back to their electronic health record at 10-14 months after amoxicillin challenge.

Outcome measures

Outcome measures
Measure	Pediatric Patients With a History of Penicillin Allergy n=21 Participants Amoxicillin: Two-dose amoxicillin challenge
Penicillin Allergy Labeling in Subjects With Negative Amoxicillin Challenge	0 Participants

Adverse Events

Pediatric Patients With a History of Penicillin Allergy

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Pediatric Patients With a History of Penicillin Allergy n=23 participants at risk Amoxicillin: Two-dose amoxicillin challenge
Skin and subcutaneous tissue disorders Rash	8.7% 2/23 • Number of events 2 • 7 days after amoxicillin challenge completion Adverse events were captured by study staff during the 60 minute observation period with amoxicillin challenge, and again assessed at 7 days after challenge completion by study staff.

Additional Information

Dr Timothy Chow

University of Texas Southwestern

Phone: 2144569093

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place