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Clinical Trials/ISRCTN51783227
ISRCTN51783227
Completed
N/A

A randomised controlled trial to compare the clinical effectiveness and safety of gentamicin and ceftriaxone in the treatment of gonorrhoea

niversity Hospital Birmingham NHS Foundation Trust (UK)0 sites720 target enrollmentSeptember 18, 2014
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Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospital Birmingham NHS Foundation Trust (UK)
Enrollment
720
Status
Completed
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

2016 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/27881151 protocol 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31056291 results (added 08/05/2019) 2019 Results article in https://www.ncbi.nlm.nih.gov/pubmed/31099330 results (added 20/05/2019) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32732336/ results (added 03/08/2020) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32829308/ (added 15/12/2021)

Registry
who.int
Start Date
September 18, 2014
End Date
December 31, 2016
Last Updated
4 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity Hospital Birmingham NHS Foundation Trust (UK)

Eligibility Criteria

Inclusion Criteria

  • •1\. Aged 16\-70 years
  • •2\. Diagnosis of uncomplicated untreated genital, pharyngeal or rectal gonorrhoea based on a positive gram stained smear on microscopy, or positive NAAT
  • •3\. Written informed consent provided

Exclusion Criteria

  • •1\. Known concurrent bacterial sexually transmitted infection (apart from chlamydia)
  • •2\. Known contraindications or allergy to gentamicin, ceftriaxone, azithromycin or lidocaine
  • •3\. Pregnant or breastfeeding
  • •4\. Current clinical diagnosis of complicated gonorrhoea infections eg pelvic inflammatory disease, epididymoorchitis
  • •5\. Weight less than 40kg at the time of randomisation
  • •6\. Currently receiving or have received ceftriaxone or gentamicin within the preceding 28 days
  • •7\. Previous participation in this study

Outcomes

Primary Outcomes

Not specified

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