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

NCT05027516 | Completed Phase 4 Results

• 1 other identifier: ITM202101
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Macrolide Resistance Determinants

  During the bioinformatic analyses, each identified antibiotic-resistance determinant will be categorized at the class level using a read-based classification tool. The primary outcome will be the ratio of mean macrolide resistance determinants in the day 14 anorectal samples between the two treatment groups. This ratio will be calculated by dividing the mean normalized read count of macrolide- resistance determinants categorized at the class level in the Ceftriaxone/Azithromycin group by the corresponding mean quantity in the Ceftriaxone group.

  Day 14

Secondary Outcomes (2)

• Read Count of Resistance Determinants for Each Non-macrolide Antibiotic Class

  Day 14

• Acquisition of Phenotypic Resistance to Azythromycin by N. Gonnorrhea

  Day 0 and Day 14

Study Arms (2)

Rocephine®

ACTIVE COMPARATOR

ceftriaxone 1g + lidocaine 35mg; intramuscular injection

Drug: Rocephin

Rocephine® + Azithromycin

ACTIVE COMPARATOR

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

Drug: Rocephin; Drug: Azithromycin

Interventions

Rocephin DRUG

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

Also known as: Ceftriaxone

Rocephine®; Rocephine® + Azithromycin

Azithromycin DRUG

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

Also known as: Zithromax

Rocephine® + Azithromycin

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Inclusion of male sex at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide written informed consent
• Male sex at birth
• At least 18 years old
• 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)

You may not qualify if:

• Use of any macrolide antibiotics (azithromycin, clarithromycin, erythromycin, roxithromycin, spiramycin) in previous 6 months
• Known contra-indications or allergy to ceftriaxone, azithromycin or lidocaine
• 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

Sponsors & Collaborators

• Institute of Tropical Medicine, Belgium: lead

Study Sites (1)

Institute of Tropical Medicine

Antwerp, 2000, Belgium

Location

MeSH Terms

Interventions

Ceftriaxone; Azithromycin

Intervention Hierarchy (Ancestors)

Cefotaxime; Cephacetrile; Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Results Point of Contact

• Title: Dr. Chris Kenyon
• Organization: Institute of Tropical Medicine Antwerp

ckenyon@itg.be

+32(0)32470786

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 30, 2021
• Study Start: January 17, 2022
• Primary Completion: May 9, 2022
• Study Completion: May 9, 2022
• Last Updated: August 2, 2024
• Results First Posted: August 2, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)