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

Last updated: February 15, 2024
Sponsor: Institute of Tropical Medicine, Belgium
Overall Status: Completed

Phase

4

Condition

Gynecological Infections

Vaginal Infection

Hiv

Treatment

Rocephin

Azithromycin

Clinical Study ID

NCT05027516
ITM202101
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 N. gonnorrhea -symptomatic or asymptomatic (Diagnosis of N. gonnorrhea will be by a positive NAATperformed according to the ITMs current laboratory protocols or for patients withurethritis a positive gram/methylene blue stain)

Exclusion

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 Sexually Transmitted Infectionsthat will (likely) require the administration of another antibiotic at the time ofenrollment, as assessed by the treating physician

Study Design

Total Participants: 42
Treatment Group(s): 2
Primary Treatment: Rocephin
Phase: 4
Study Start date:
January 17, 2022
Estimated Completion Date:
May 09, 2022

Connect with a study center

  • Institute of Tropical Medicine

    Antwerpen, 2000
    Belgium

    Site Not Available

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