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

NCT ID: NCT05027516

Last Updated: 2024-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2022-05-09

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Rocephine®

ceftriaxone 1g + lidocaine 35mg; intramuscular injection

Group Type: ACTIVE_COMPARATOR

Rocephin

Intervention Type: DRUG

Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection

Rocephine® + Azithromycin

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

Group Type: ACTIVE_COMPARATOR

Rocephin

Intervention Type: DRUG

Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection

Azithromycin

Intervention Type: DRUG

Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally

Interventions

Rocephin

Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection

Intervention Type: DRUG

Azithromycin

Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally

Intervention Type: DRUG

Other Intervention Names

Ceftriaxone; Zithromax

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Institute of Tropical Medicine, Belgium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institute of Tropical Medicine

Antwerp, , Belgium

Countries

Belgium

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

ITM202101

Identifier Type: -

Identifier Source: org_study_id