A randomised controlled trial to compare the clinical effectiveness and safety of gentamicin and ceftriaxone in the treatment of gonorrhoea. - G-TOG - Gentamicin in the Treatment of Gonorrhoea

niversity Hospitals Birmingham NHS Foundation Trust0 个研究点目标入组 720 人开始时间: 2014年6月26日最近更新: 2019年4月30日

适应症

试验速览

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•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

•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

发起方

niversity Hospitals Birmingham NHS Foundation Trust