Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study

Phase 3

Not yet recruiting

• Conditions: Neisseria Gonorrhoeae Infection; Asymptomatic Pharyngeal Carriage
• Interventions: Other: Absence of antibiotic treatment; Drug: Ceftriaxone

• Registration Number: NCT05971550
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

Since the use of antibiotics, Neisseria Gonorrhoeae (NG) has acquired progressive resistance to penicillins, sulfonamides, tetracyclines and quinolones. The oropharynx is recognized as an important site for DNA exchange between NG and other commensal Neisseria, allowing NG to acquire new antimicrobial resistance. Despite the worrying data on the emergence of resistant NG, the recommendations remain to systematically treat these infections with ceftriaxone, including asymptomatic pharyngeal localizations. The objective of our study is to evaluate a ceftriaxone sparing strategy in order to limit the emergence of antibiotic resistance.

The primary objective of the study is to evaluate the clearance of Neisseria gonorrhoeae, 3 months after the diagnosis of asymptomatic pharyngeal carriage documented on nucleic acid amplification test (NAAT).

Detailed Description

Non-inferiority, multicenter, prospective, randomized open-label study, in two parallel arms, comparing the pharyngeal clearance of Neisseria gonorrhoeae (NG) at 3 months with or without treatment with ceftriaxone.

Experimental group: Absence of antibiotic treatment for at most 3 months after screening for asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to Sexually Transmitted Infection or positive Polymerase chain reaction (PCR) at 3 months)

Control group: Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose, according to the national recommendations in force, to be repeated if pharyngeal Polymerase chain reaction (PCR) again positive for NG during follow-up.

Study Timeline

• Status Verified: 2023-02
• Study First Submitted: 2023-04-14
• Study First Submitted QC: 2023-07-24
• Last Update Submitted: 2023-07-24
• Study First Posted: 2023-08-02
• Last Update Posted: 2023-08-02
• Study Start: 2023-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 254

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients : Absence of antibiotic treatment	Absence of antibiotic treatment	-
Patients : Ceftriaxone	Ceftriaxone	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)	3 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Proportion of identical genome between partner and patient	Up to 3 months
Proportion of patients with negative pharyngeal NG cultures	at 3 months after inclusion
Proportion of partners with Resistant NG strains	Up to 3 months
Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) and a negative pharyngeal culture for Neisseria gonorrhoeae (NG)	at 1 month after inclusion
Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)	at 3 months after inclusion	Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae	at 3 months after inclusion	Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
Proportion of patients with Resistant NG strains	Up to 3 months
Proportion of patients with spontaneous pharyngeal clearance of NG	at 3 months after inclusion	Analysis of the factors associated with spontaneous pharyngeal clearance of NG : * Socio-demographic and behavioural characteristics; * Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR; * Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions
Proportion of partners with NAAT positive for NG	at 3 months after inclusion of the partner	Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
Proportion of partners with NG cultures positive	at 3 months after inclusion of the partner	Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
Proportion of adverse events	Up to 3 months