ResistAZM: Trial Comparing Ceftriaxone Plus Azithromycin Versus Ceftriaxone for the Treatment of Gonorrhea
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Rocephine® ceftriaxone 1g + lidocaine 35mg; intramuscular injection |
Drug: Rocephin
Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection
Other Names:
|
| Active Comparator: Rocephine® + Azithromycin ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally |
Drug: Rocephin
Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection
Other Names:
Drug: Azithromycin
Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- Read count of resistance determinants for each macrolide and non-macrolide antibiotic class [Day 14]
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
- Proportion of oropharyngeal commensal Neisseria that are macrolide resistant [Day 14]
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.
- 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
- Diameter of the inhibition zone of N gonnorrhea [Day 14]
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
Eligibility Criteria
Criteria
Inclusion criteria:
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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)
Exclusion criteria:
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Use of any macrolide antibiotics (azithromycin, clarithromycin, erythromycin, roxithromycin, spiramycin) in previous 6 months
-
Known contra-indications or allergy to ceftriaxone, azithromycin or lidocaine
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Institute of Tropical Medicine | Antwerpen | Belgium | 2000 |
Sponsors and Collaborators
- Institute of Tropical Medicine, Belgium
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ITM202101