Gonorrhoea MedDRA version: 18.0 Level: PT Classification code 10018612 Term: Gonorrhoea System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Various
Product Name: Gentamicin sulphate
Product Code: NA
Pharmaceutical Form: Injection
INN or Proposed INN: Gentamicin su
Sponsors
University Hospitals Birmingham NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Individuals must meet ALL of the following to be included in the study • Individuals aged 16-70 years. • Diagnosis of uncomplicated untreated* genital, pharyngeal or rectal gonorrhoea based on a positive gram stained smear on microscopy, or positive NAAT within the last 4 weeks. • Written informed consent provided. *patient has not received any antibiotic in previous 28 days which could have treated gonorrhoea (either partially or completely) Are the trial subjects under 18? yes Number of subjects for this age range: 72 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 612 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 36
Exclusion criteria
Exclusion criteria: Individuals will be excluded from the study if they meet ANY of the following •Known concurrent bacterial sexually transmitted infection (apart from chlamydia). Known bacterial vaginosis or Trichomonas vaginalis •Known contra-indications or allergy to gentamicin, ceftriaxone, azithromycin or lidocaine. • Pregnant or breast-feeding. • Current clinical diagnosis of complicated gonorrhoea infections eg pelvic inflammatory disease, epididymo-orchitis. • Weight less than 40kg at the time of randomisation • Currently receiving or have received ceftriaxone, gentamicin or azithromycin within the preceding 28 days. • Previous participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The principle objective of the study is to determine whether gentamicin is an acceptable alternative to ceftriaxone, in the treatment of gonorrhoea. This will be done by determining whether the clearance rate of gonorrheoa in participants receiving gentamicin is no worse than the rate in participants receiving ceftriaxone. In parallel, the safety of both treatments will be assessed.; Secondary Objective: The secondary objectives of the study are: • To determine whether a single intramuscular dose of gentamicin is safe and well tolerated • To determine whether a single intramuscular dose of gentamicin is cost effective to the NHS when used to treat gonorrhoea • To determine the relationship between clinical effectiveness and the laboratory measurement of antibiotic effectiveness (the minimum inhibitory concentration (MIC) required to inhibit growth of N. gonorrhoeae) ;Primary end point(s): The primary outcome measure is clearance of N. gonorrhoeae at all the infected sites confirmed by a negative NAAT (Aptima Combo), two weeks post treatment (as recommended by the British Association for Sexual Health and HIV).;Timepoint(s) of evaluation of this end point: 2 weeks after treatment with study drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary end points are • clinical resolution of symptoms • frequency of nausea/vomiting, hearing loss, dizziness and rash. • frequency of other adverse events • tolerability of therapy • relationship between clinical effectiveness and MIC to inhibit N. gonorrhoeae growth • cost effectiveness ;Timepoint(s) of evaluation of this end point: All secondary end points will be evaluated at the 2-week follow up visit. | — |
Countries
United Kingdom
Contacts
Public ContactG-ToG Study manager
Nottingham Clinical Trials Unit
Outcome results
None listed