Gonorrhea Neisseria gonorrhoeae
Conditions
Interventions
- Reference treatment: single dose ceftriaxone 500 mg IM, dissolved in 2 ml
lidocaine 1% supplemented with 0.9% NaCl until 10 ml (2 x 5 ml).
- Experimental arm 1: single dose ertapenem 1000 mg IM, di
Gonorrhoea
Neisseria gonorrhoeae
Treatment
Sponsors
AMC dermatologie
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 18 years old and older Anorectal, cervical, urethral or vaginal gonorrhea; confirmed by positive gram stain and NAAT / culture Willing to return for test of cure Willing to abstain from sex or use condoms until follow-up visit Provide informed consent
Exclusion criteria
Exclusion criteria: Complicated gonorrhea Genital ulcer at inclusion visit Known Chlamydia trachomatis infection Pregnant or breastfeeding Unable to read Dutch or English Newly diagnosed HIV infection CD4+ cell count
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Bacterial eradication of Ng-infection at the included infection site, based on a test of cure (TOC) using an RNA-based NAAT (Aptima Combo 2 assay) at the follow-up visit 7-14 days after treatment (T7), or - Meet the criteria for treatment failure as described in the protocol (7.1.1.) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Bacterial eradication of Ng-infection at the included infection site, based on TOC using an RNA-based NAAT 7-28 days after treatment. 2. Bacterial eradication of Ng-infection at any infected site(s) not included in the primary endpoint analysis, based on a TOC using an RNA-based NAAT 7-28 days after treatment. 3. Any adverse events (type, frequency and severity) occurring during 7-14 days following the start of treatment, and during 1 month after treatment. 4. In vitro MICs of all Ng-strains for all study antimicrobials, determined by e-test on culture at inclusion (before treatment, T0) and at the TOC follow-up visit (T7). 5. a. Symptoms (such as pain, irritation/itch, redness, any discharge, bleeding, changed defecation pattern and/or swelling) from treatment to TOC visit (7-14 days). b. Time (in days) from the start of treatment to disappearance of symptoms. c. Signs (such as mucosal fragility, redness, discharge, bleeding and/or swelling) assessed at physical examination if indicated, at T0 and T7. 6. Pharmacokinetic characteristics of study drugs in peripheral blood up to 24 hours after administration. | — |
Countries
The Netherlands
Outcome results
None listed