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

Phase 4

Completed

• Conditions: Neisseria Gonorrhoeae
• Interventions: Drug: Rocephin; Drug: Azithromycin

• Registration Number: NCT05027516
• Lead Sponsor: Institute of Tropical Medicine, Belgium

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-20
• Study First Submitted QC: 2021-08-24
• Study First Posted: 2021-08-30
• Study Start: 2022-01-17
• Primary Completion: 2022-05-09
• Study Completion: 2022-05-09
• Results First Submitted: 2023-06-05
• Status Verified: 2024-02
• Results First Submitted QC: 2024-02-15
• Last Update Submitted: 2024-02-15
• Results First Posted: 2024-08-02
• Last Update Posted: 2024-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 42

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rocephine® + Azithromycin	Azithromycin	ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally
Rocephine®	Rocephin	ceftriaxone 1g + lidocaine 35mg; intramuscular injection
Rocephine® + Azithromycin	Rocephin	ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally

Primary Outcome Measures

Name	Time	Method
Macrolide Resistance Determinants	Day 14	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.

Secondary Outcome Measures

Name	Time	Method
Read Count of Resistance Determinants for Each Non-macrolide Antibiotic Class	Day 14	The ratio of mean normalized read count of resistance determinants for each non-macrolide antibiotic class in the day 14 anorectal samples between the two treatment groups
Acquisition of Phenotypic Resistance to Azythromycin by N. Gonnorrhea	Day 0 and Day 14	The difference in time until acquisition of phenotypic resistance to Azithromycin by N. gonnorrhea in the morbidostat upon exposure to commensal Neisseria DNA extracts from each treatment group

Trial Locations

Locations (1)

Institute of Tropical Medicine; 🇧🇪 Antwerpen, Belgium