drugset / Trial / NCT05027516

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

NCT05027516

Phase 4 Completed 42 enrolled Institute of Tropical Medicine, Belgium
RandomizedParallel-groupQuadruple-blindSupportive care

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.

Timeline

Start
2022-01-17
Primary completion
2022-05-09
Completion
2022-05-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Azithromycin Small molecule 2 g Oral
Comparator Ceftriaxone Other / unclassified 1 g Intramuscular
Comparator Lidocaine Other / unclassified 35 mg Intramuscular

Indications