Evidence map›Paper›PMID 38325290›Full record

Trial reportClinical infectious diseases : an official publication of the Infectious Diseases Society of America2024

Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients.

Rebecca A Lillis, Lindley A Barbee, Candice J McNeil, Lori Newman, J Dennis Fortenberry, Santiago Alvarez-Arango, Jonathan M Zenilman

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Clinical infectious diseases : an official publication of the Infectious Diseases Society of America, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04620746 (Validate an Easy to Administer Algorithm to Define Penicillin), which is not on this map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04620746 phase4completednot on this map

Validate an Easy to Administer Algorithm to Define Penicillin (PCN-B-lactam) Allergy Status in Sexually Transmitted Disease (STD) Clinic Outpatients

TypeinterventionalSponsorJohns Hopkins UniversityRan2021 to 2022Enrolled284ConditionsPenicillin AllergyArmsPenicillin Major Determinant (PrePen) Skin Testing, Direct Oral challenge
3 · Its place in the literature

Who cites it

3 citing papers in PubMed.

  1. Article
  2. Antiquated Tools to Fight an Ancient Foe.The New England journal of medicine · 2025
    Article
  3. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Rebecca A LillisSection of Infectious Diseases, Louisiana State University School of Medicine, New Orleans, Louisiana, USA.
Lindley A BarbeeDivision of Infectious Diseases, University of Washington, Seattle, Washington, USA.
Candice J McNeilSection of Infectious Diseases, Wake Forest University School of Medicine, Winston-Salem, North Carolina, USA.
Lori NewmanNational Institute of Allergy and Infectious Diseases, Rockville, Maryland, USA.
J Dennis FortenberryDivision of Adolescent Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.
Santiago Alvarez-ArangoDivision of Clinical Pharmacology, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
Jonathan M ZenilmanDivision of Infectious Diseases, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0003-0244-6973

Funding

NIH HHS
6 · The paper itself

Abstract

backgroundApproximately 15% of patients in sexually transmitted infection (STI) clinics report penicillin allergies, complicating treatment for syphilis and gonorrhea. Nonetheless, >90% do not have a penicillin allergy when evaluated. We developed and validated an algorithm to define which patients reporting penicillin allergy can be safely treated at STI clinics with these drugs.

methodsRandomized controlled trial to assess feasibility and safety of penicillin allergy evaluations in STI clinics. Participants with reported penicillin allergy answered an expert-developed questionnaire to stratify risk. Low-risk participants underwent penicillin skin testing (PST) followed by amoxicillin 250 mg challenge or a graded oral challenge (GOC)-amoxicillin 25 mg followed by 250 mg. Reactions were recorded, and participant/provider surveys were conducted.

resultsOf 284 participants, 72 (25.3%) were deemed high risk and were excluded. Of 206 low-risk participants, 102 (49.5%) underwent PST without reactions and 3 (3%) had mild reactions during the oral challenge. Of 104 (50.5%) participants in the GOC, 95 (91.3%) completed challenges without reaction, 4 (4.2%) had mild symptoms after 25 mg, and 4 (4.2%) after 250-mg doses. Overall, 195 participants (94.7%) successfully completed the study and 11 (5.3%) experienced mild symptoms. Of 14 providers, 12 (85.7%) completed surveys and 11 (93%) agreed on the safety/effectiveness of penicillin allergy assessment in STI clinics.

conclusionsAn easy-to-administer risk-assessment questionnaire can safely identify patients for penicillin allergy evaluation in STI clinics by PST or GOC, with GOC showing operational feasibility. Using this approach, 67% of participants with reported penicillin allergy could safely receive first-line treatments for gonorrhea or syphilis. Clinical Trials Registration. Clinicaltrials.gov (NCT04620746).

Indexed as

AlgorithmsDrug HypersensitivityPenicillinsAdultAnti-Bacterial AgentsFeasibility StudiesFemaleHumansMaleMiddle AgedOutpatientsSexually Transmitted DiseasesSkin TestsSurveys and QuestionnairesYoung AdultAnti-Bacterial AgentsPenicillinsallergy skin testingallergy testingbeta-lactam allergygraded oral challengepenicillin allergy

Identifiers

PMID38325290
PMCPMC11093667

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.