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

Neisseria Gonorrhoeae Clinical Trial

— ResistAZM  

Official title:

An Open Label Randomized Controlled Trial Comparing the Effect of Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Neisseria Gonorrhoeae on the Resistome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05027516
• Other study ID #: ITM202101
• Status: Completed
• Phase: Phase 4
• Start date: January 17, 2022
• Est. completion date: May 9, 2022

Study information

• Verified date: March 2023
• Source: Institute of Tropical Medicine, Belgium
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: May 9, 2022
• Est. primary completion date: May 9, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gonorrhea
• Neisseria Gonorrhoeae

Intervention

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

Locations

Country	Name	City	State
Belgium	Institute of Tropical Medicine	Antwerpen

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Tropical Medicine, Belgium

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Read count of resistance determinants for each non-macrolide antibiotic class	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	Day 14
Secondary	Read count of resistance determinants for each macrolide and non-macrolide antibiotic class	The ratio of mean normalized read count of resistance determinants for each macrolide and non-macrolide antibiotic class in the day 14 oropharyngeal samples between the two treatment groups	Day 14
Secondary	Proportion of oropharyngeal commensal Neisseria that are macrolide resistant	The difference in proportion of oropharyngeal commensal Neisseria that are macrolide resistant between the two treatment groups at day 14. For each individual the proportion of oropharyngeal commensal Neisseria that are macrolide resistant will be calculated by dividing the number of macrolide-resistant colonies of commensal Neisseria grown on modified LB agar-azithromycin-1mg/L by the total number of commensal Neisseria colonies grown on modified LB agar without Azithromycin.	Day 14
Secondary	Acquisition of phenotypic resistance to Azythromycin by N. gonnorrhea	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	Day 0 and Day 14
Secondary	Diameter of the inhibition zone of N gonnorrhea	The difference in diameter of the inhibition zone of N. gonnorrhea during agar overlay experiments using oropharyngeal commensal Neisseria and Streptococci from day 14 samples from each treatment group	Day 14