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

NCT05971550 | Unknown Phase 3 DMC

• 1 other identifier: APHP210080
• Study Type: interventional
• Target: 254
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Neisseria Gonorrhoeae Infection; Asymptomatic Pharyngeal Carriage

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)

  3 months after inclusion

Secondary Outcomes (18)

• 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 with negative pharyngeal NG cultures

  at 3 months after inclusion

• Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)

  at 1 month after inclusion

• Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae

  at 1 month after inclusion

• Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)

  at 3 months after inclusion

Study Arms (2)

Patients : Absence of antibiotic treatment

EXPERIMENTAL

Other: Absence of antibiotic treatment

Patients : Ceftriaxone

ACTIVE COMPARATOR

Drug: Ceftriaxone

Interventions

Absence of antibiotic treatment OTHER

Absence of antibiotic treatment for at most 3 months after screening for asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to STI or positive PCR at 3 months)

Patients : Absence of antibiotic treatment

Ceftriaxone DRUG

Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose, according to the national recommendations in force, to be repeated if pharyngeal PCR again positive for NG during follow-up

Patients : Ceftriaxone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patient (age ≥ 18 years old)
• Patient consulting for a pharyngeal Neisseria gonorrhoeae Sexually Transmitted Infection (STI) and meeting the following criteria :
• asymptomatic patient
• Patient's agreement to use protection or abstinence from all oral sex for 3 months follow-up (experimental group) or for 7 days (control group)
• For men whose female partner(s) are of childbearing age and for women of childbearing age: use of effective contraception (failure rate less than 1% per year) throughout research
• Patient benefiting from a social health security scheme
• Patient having signed a free and informed consent
• Minor patient
• Symptomatic patient in the pharynx
• Hypersensitivity to ceftriaxone, other cephalosporins or to any of the excipients
• History of severe hypersensitivity (e.g. anaphylactic reaction) to another class of antibacterial agents of the beta-lactam family (penicillins, monobactams and carbapenems).
• Contraindication to ceftriaxone
• Contraindication to intramuscular injections
• Person under legal protection, under guardianship or curatorship, person deprived of liberty, under safeguard of justice, subject to psychiatric care, under duress, admitted to a health or social establishment for purposes other than those of research
• Pregnant or breastfeeding woman

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Gonorrhea

Interventions

Ceftriaxone

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

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

Central Study Contacts

Claire Pintado, Dr

CONTACT

+33142494973; claire.pintado@aphp.fr

Jérôme Lambert, Dr

CONTACT

+33142499742; jerome.lambert@u-paris.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: August 2, 2023
• Study Start: September 1, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 2, 2023

Record last verified: 2023-02