Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea (ResistAZM)

Institute of Tropical Medicine, Belgium

Status and phase: Completed; Phase 4

Conditions: Neisseria Gonorrhoeae

Treatments: Drug: Rocephin; Drug: Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT05027516

ITM202101

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 NAAT performed according to the ITMs current laboratory protocols or for patients with urethritis a positive gram/methylene blue stain)

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 Infections that will (likely) require the administration of another antibiotic at the time of enrollment, as assessed by the treating physician

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups

Rocephine®

Active Comparator group

Description:

ceftriaxone 1g + lidocaine 35mg; intramuscular injection

Treatment:

Drug: Rocephin

Rocephine® + Azithromycin

Active Comparator group

Description:

ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally

Treatment:

Drug: Azithromycin

Drug: Rocephin