A trial comparing the effect of ceftriaxone plus azithromycin versus ceftriaxone for the treatment of Neisseria gonorrhoeae on the resistance genes

Phase 1

• Conditions: eisseria gonorrhoeae (Ng); MedDRA version: 21.1Level: LLTClassification code 10051970Term: Neisseria gonorrhoeae infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2021-003616-10-BE
• Lead Sponsor: Institute of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-15
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

1.Able and willing to provide written informed consent
2.Male sex at birth
3.At least 18 years old
4.Confirmed diagnosis of urethritis, proctitis or pharyngitis Ng – symptomatic or asymptomatic (Diagnosis of Ng will be by a positive NAAT performed according to the ITMs current laboratory protocols or for patients with urethritis a positive gram/methylene blue stain)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 38
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1.Use of any macrolide antibiotics (azithromycin, clarithromycin, erythromycin, roxithromycin, spiramycin) in previous 6 months
2.Known contra-indications or allergy to ceftriaxone, azithromycin or lidocaine

3.Presence of any other condition, including other STIs that will (likely) require the administration of another antibiotic at the time of enrollment, as assessed by the treating physician

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified