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A Study of the Impact of Penicillin Allergy on Antimicrobial Resistance and ouTcomes

NCT07177690 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 214

Last updated 2025-09-17

No results posted yet for this study

Summary

Penicillin allergy is one of the commonest reported allergies. The presence of a penicillin allergy record in a patients notes leads to the avoidance of recommended first-line penicillin antibiotics and the use of alternative non-penicillin antibiotics which can be less effective, have more side effects and have a greater propensity to drive antimicrobial resistance (AMR). Most patients with penicillin allergy records do not have a true allergy when they are tested by a specialist, so many patients are denied the best antibiotics because of an incorrect penicillin allergy record.

The study will investigate how having a penicillin allergy impacts on treatment for patients who need antibiotics when they are hospitalised with COVID-19 and how penicillin allergy affects AMR.

Antibiotic use is the main driver of AMR, antibiotic use can also disrupt the bacteria that normally live in our guts and mouths. These bacterial communities also known as the gastrointestinal (GI) and oral microbiome respectively, help us digest food and prevent infections. Antibiotic use can 'kill off' these harmless bacteria and lead to an increase in bacteria which have genes that make them resistant to antibiotics (antibiotic resistance genes). The study investigators believe that patients with penicillin allergy are likely to have a greater number of antibiotic resistance genes in their oral and GI microbiomes, ans that this will make it more likely that they will fail antibiotic treatment and will increase their risk of transmitting resistance to others.

The study objectives are:

1. To determine how penicillin allergy impacts on clinical outcomes in patients admitted with COVID-19
2. To find out if AMR genes in the oral microbiome of people with a penicillin allergy record are different to those without a penicillin allergy record
3. To investigate whether AMR genes are lost in patients who have an incorrect penicillin allergy label removed

Conditions

  • Penicillin Allergy
  • Antimicrobial Drug Resistance
  • AMR

Sponsors & Collaborators

  • University of Leeds

    lead OTHER

Principal Investigators

  • Shadia Ahmed, MBChB · Univeristy of Leeds

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-30
Primary Completion
2024-04-24
Completion
2025-12-01

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07177690 on ClinicalTrials.gov