Trial Outcomes & Findings for Penicillin Allergy Testing in STD Clinics (NCT NCT04620746)

NCT ID: NCT04620746

Last Updated: 2023-09-21

Results Overview

Used yes/no questionnaire designed by study team. Any positive response on the high-risk history was grounds for exclusion from randomization to allergy testing arm

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

284 participants

Primary outcome timeframe

Baseline

Results posted on

2023-09-21

Participant Flow

Patients were recruited from 4 STI clinics. Enrollment criteria were whether they reported a history of having had, or been told that they have penicillin or beta-lactam allergy

All participants were administered a risk questionnaire to determine whehter they were classfied as high-risk or low risk for true penicillin allergy, based on input from allergy experts. Subjects who ahd a high risk history (eg hives within past 5 years) were referred for further allergist evaluation, as they were deemed too high risk to be evaluated further in an STI clinic

Participant milestones

Participant milestones
Measure
Skin Testing Arm
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Direct Oral Challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Overall Study
STARTED
139
145
Overall Study
COMPLETED
136
144
Overall Study
NOT COMPLETED
3
1

Reasons for withdrawal

Reasons for withdrawal
Measure
Skin Testing Arm
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Direct Oral Challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Overall Study
Adverse Event
2
0
Overall Study
Uniterpretable skin test
1
0
Overall Study
Withdrawal by Subject
0
1

Baseline Characteristics

Penicillin Allergy Testing in STD Clinics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Skin Testing Arm
n=139 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Direct Oral Challenge
n=145 Participants
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Total
n=284 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Age, Categorical
Between 18 and 65 years
137 Participants
n=99 Participants
143 Participants
n=107 Participants
280 Participants
n=206 Participants
Age, Categorical
>=65 years
2 Participants
n=99 Participants
2 Participants
n=107 Participants
4 Participants
n=206 Participants
Age, Continuous
35.9 years
n=99 Participants
37.4 years
n=107 Participants
36.6 years
n=206 Participants
Sex: Female, Male
Female
45 Participants
n=99 Participants
41 Participants
n=107 Participants
86 Participants
n=206 Participants
Sex: Female, Male
Male
94 Participants
n=99 Participants
104 Participants
n=107 Participants
198 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
19 Participants
n=99 Participants
15 Participants
n=107 Participants
34 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
117 Participants
n=99 Participants
130 Participants
n=107 Participants
247 Participants
n=206 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=99 Participants
0 Participants
n=107 Participants
3 Participants
n=206 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
n=99 Participants
6 Participants
n=107 Participants
9 Participants
n=206 Participants
Race (NIH/OMB)
Asian
1 Participants
n=99 Participants
6 Participants
n=107 Participants
7 Participants
n=206 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
n=99 Participants
1 Participants
n=107 Participants
2 Participants
n=206 Participants
Race (NIH/OMB)
Black or African American
29 Participants
n=99 Participants
42 Participants
n=107 Participants
71 Participants
n=206 Participants
Race (NIH/OMB)
White
104 Participants
n=99 Participants
90 Participants
n=107 Participants
194 Participants
n=206 Participants
Race (NIH/OMB)
More than one race
1 Participants
n=99 Participants
0 Participants
n=107 Participants
1 Participants
n=206 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=99 Participants
0 Participants
n=107 Participants
0 Participants
n=206 Participants
Region of Enrollment
United States
139 Participants
n=99 Participants
145 Participants
n=107 Participants
284 Participants
n=206 Participants

PRIMARY outcome

Timeframe: Baseline

Used yes/no questionnaire designed by study team. Any positive response on the high-risk history was grounds for exclusion from randomization to allergy testing arm

Outcome measures

Outcome measures
Measure
Skin Testing Arm
n=139 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose Direct Oral challenge: Direct oral challenge with amoxicillin 250mg single dose
Direct Oral Challenge
n=145 Participants
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Number of Respondents Who Responded YES to Any Question Defining High Risk Penicillin Allergy Using Questionnaire Developed by the Study
36 Participants
36 Participants

PRIMARY outcome

Timeframe: 30 minutes after intervention

Population: Number of participants analyzed is the number who completed the testing modalities

Safety was determined by the presence or absence of adverse reactions. Symptoms assessed included pruritis, flushing, shortness of breath. Physical examination included vital signs, blood pressure, pulse, respiratory rate and peak expiratory flow

Outcome measures

Outcome measures
Measure
Skin Testing Arm
n=99 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose Direct Oral challenge: Direct oral challenge with amoxicillin 250mg single dose
Direct Oral Challenge
n=103 Participants
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Safety of Direct Oral Challenge Defined by Number of Subjects Who Did Not Have Pre-defined Changes in Vital Signs or Pre-defined Emergence of New Respiratory or Skin Symptoms After Oral Challenge
96 Participants
95 Participants

SECONDARY outcome

Timeframe: Immediately after intervention

Population: The numbers reflected in Participants Analyzed for this outcome represent the number of participants who completed the Acceptability questionnaire.

Brief Acceptabilty Questionnaire to subjects on acceptability of PCN allergy testing in the STD clinic setting. Reported as number of participants who found testing acceptable. Questionnaire asked subjects whether they found the process helpful and whether they would return for this type of testing. Using a 1-5 scale, with 1 defined as extremely helpful and 5 defined as not helpful.

Outcome measures

Outcome measures
Measure
Skin Testing Arm
n=99 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose Direct Oral challenge: Direct oral challenge with amoxicillin 250mg single dose
Direct Oral Challenge
n=89 Participants
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Patient Acceptability of PCN Testing/Oral Challenge Assessed by a Study Team Developed Questionnaire
99 Participants
89 Participants

SECONDARY outcome

Timeframe: 18 months

Population: Response to questionnaire was optional

Provider assessment of feasibility of providing PCN testing in the STD clinic setting. This was based on a team-developed questionnaire using Likert scale questions that asked about feasibility and self-efficacy in performing the assessments. Feasibility defined by 1-5 scale, with 1= highly feasible and 5=not feasible. Reported as number of providers who found PCN testing feasible.

Outcome measures

Outcome measures
Measure
Skin Testing Arm
n=11 Participants
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose Direct Oral challenge: Direct oral challenge with amoxicillin 250mg single dose
Direct Oral Challenge
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Provider Assessment of Feasibility of Allergy Evaluation at the End of Study
11 Participants

Adverse Events

Skin Testing Arm

Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths

Direct Oral Challenge

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Skin Testing Arm
n=139 participants at risk
These subjects with reported PCN allergy and reported low risk responses will receive skin testing followed by oral challenge Penicillin Major Determinant (PrePen) Skin Testing: Skin testing followed by oral challenge with amoxicillin 250 mg single dose Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Direct Oral Challenge
n=145 participants at risk
These subjects with reported PCN allergy and low risk responses will bypass skin testing and have direct oral challenge with amoxicillin Direct Oral challenge: Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
Immune system disorders
Minor adverse events
11.5%
16/139 • Number of events 16 • Adverse events were recorded up to 1 week post intervention
9.0%
13/145 • Number of events 13 • Adverse events were recorded up to 1 week post intervention

Additional Information

Jonathan Zenilman

Johns Hopkins University School of Medicine

Phone: 410-550-9080

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place