ew Antibiotic Treatment Options for Uncomplicated Anogenital Gonorrhoea infections

Phase 3

Completed

• Conditions: Gonorrhea; Neisseria gonorrhoeae; 10004018

• Registration Number: NL-OMON49273
• Lead Sponsor: AMC dermatologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 406

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

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 <200 cells/ul
Known allergy to the study antibiotics
History of renal impairment, liver cirrosis and/or heart failure
Concurrent use of any of the following: systemic antibiotics/immunosuppressives/valproic acid
Previous enrolment in the study
Current participation in other non-observational medical research

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Bacterial eradication of Ng-infection at the included infection site, based<br /><br>on a test of cure (TOC) using an RNA-based NAAT (Aptima Combo 2 assay) at the<br /><br>follow-up visit 7-14 days after treatment (T7), or<br /><br>- Meet the criteria for treatment failure as described in the protocol (7.1.1.)</p><br>