NCT05027516

Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea

An Open Label Randomized Controlled Trial Comparing the Effect of Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Neisseria Gonorrhoeae on the Resistome

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Institute of Tropical Medicine, Belgium · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this Randomized Controlled Trial, the investigators will recruit 42 men attending the STI and HIV clinic at the Institute of Tropical Medicine, with a diagnosis of N. gonorrhoeae and randomize them 1:1 to receive either ceftriaxone or ceftriaxone/azithromycin. They will be followed-up for a test of cure visit at day 14 post-treatment where urine, oropharyngeal and anorectal samples will be taken to test for cure and monitor treatment effects on the microbiome and resistome. The primary outcome will be evaluating the difference in the abundance of resistance conferring genes in the rectal microbiome in the two arms, 14 days after the receipt of therapy.

Conditions

• Neisseria Gonorrhoeae

Interventions

Type	Name	Description
DRUG	Rocephin	Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection
DRUG	Azithromycin	Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally

Timeline

• Start date: 2022-01-17
• Primary completion: 2022-05-09
• Completion: 2022-05-09
• First posted: 2021-08-30
• Last updated: 2024-08-02
• Results posted: 2024-08-02

Locations

1 site across 1 country: Belgium