THE ANTIBIOTIC GUARDIAN STUDY

  • Research type

    Research Study

  • Full title

    THE ANTIBIOTIC GUARDIAN STUDY: AN INTERVENTIONAL STUDY OF ANTIBIOTIC-RESISTANCE GUIDED THERAPY FOR MYCOPLASMA AND GONORRHOEA INFECTIONS.

  • IRAS ID

    269508

  • Contact name

    Lucy Jones

  • Contact email

    Lucy.Jones14@wales.nhs.uk

  • Sponsor organisation

    Cwm Taf Morgannwg University Health Board

  • Duration of Study in the UK

    2 years, 0 months, 5 days

  • Research summary

    ANTIBIOTIC GUARDIAN STUDY: AN INTERVENTIONAL STUDY OF ANTIBIOTIC-RESISTANCE GUIDED THERAPY FOR MYCOPLASMA AND GONORRHOEA INFECTIONS.
    PRIMARY RESEARCH QUESTION:
    Does rapid antibiotic-resistance guided therapy for Mycoplasma and Gonorrhoea reduce the time to microbiological cure and symptom resolution compared to standard treatment?
    SECONDARY QUESTION:
    Does rapid antibiotic-resistance guided therapy for Mycoplasma and Gonorrhoea reduce the empirical prescribing of antibiotics, compared to standard treatment?

    JUSTIFICATION FOR THE RESEARCH
    The Chief Medical Officer has reported that antimicrobial resistance (AMR) is one the biggest health threats and sexual health has emerged as a frontline of the battle. It is having a major impact on treatment of patients with Sexually Transmitted Infection (STI) and on Public Health at large. Mycoplasma and Gonorrhoea have received significant International attention due to their increasing AMR.

    Mycoplasma are sexually transmitted bacteria.They are resistant (not killed) to most antibiotics. This often means that patients receiving routine treatment for Mycoplasma will continue to have the infection. Gonorrhoea is a well-known STI and an increase in cases of multi-drug resistant infections have made successfully treating this infection a real challenge.
    AMR has a major impact on treatment of patients with these STI and are increasingly being transmitted from mother-to-baby resulting in neonatal infection.
    Our aim is to use rapid modern tests to tell us (the same day) which antibiotic will treat the infection, this is called 'antibiotic-resistance guided therapy'.We hope this will cure the infection more quickly. We also aim to reduce routine use of antibiotics in an attempt to practice true antibiotic guardianship. A controlled trial will be performed over the course of 2 years and recruit 1000 participants. Participants will be symptomatic patients attending a sexual health walk-in hospital clinic. All participants will continue to receive routine testing. Participants in the interventional cohort will also have new AMR tests and timely treatment with different antibiotics.

  • REC name

    Wales REC 7

  • REC reference

    19/WA/0221

  • Date of REC Opinion

    27 Aug 2019

  • REC opinion

    Favourable Opinion