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

Neisseria Gonorrhoeae Infection Clinical Trial

— PORTAPHAR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05971550
• Other study ID #: APHP210080
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 2023
• Est. completion date: December 2025

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Claire Pintado, Dr
• Phone: +33142494973
• Email: claire.pintado[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 254
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Patients (n=154):

Patient inclusion criteria :

• Adult patient (age = 18 years old)
• Patient consulting for a pharyngeal Neisseria gonorrhoeae Sexually Transmitted

Infection (STI) and meeting the following criteria :

• Positive sample for NAAT by PCR in the pharynx for Neisseria gonorrhoeae dating back a maximum of 7 days (the date of the sample and those of inclusion will be compared) and
• asymptomatic patient
• Absence of symptoms of other bacterial STIs or other asymptomatic bacterial STIs confirmed on the systematic screening assessment carried out within 7 days before inclusion
• 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

Patients non-inclusion criteria :

• Minor patient
• Symptomatic patient in the pharynx
• Presence of symptoms of another bacterial STI or of an asymptomatic bacterial STI confirmed on the screening report carried out within 7 days before inclusion
• Antibiotic treatment that may be active on Neisseria gonorrhoeae (C3G, Fluoroquinolones, Macrolides, Cyclins, Aminosides, Penicillins) within 14 days before inclusion
• 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
• Lack of social health insurance
• Patient included in another interventional study Partners (n=100) :

Partner Inclusion Criteria :

• Sexual contact of the index case (genito-anal or genito-vaginal, oro-genital or oro-anal or oro-oral relations) in the month preceding the inclusion of the index case
• Adult patient (age = 18 years old)
• Patient benefiting from a social health security scheme
• Patient having signed a free and informed consent

Partner non-inclusion Criteria:

• Minor patient
• 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
• Patient included in another interventional study
• Pregnant or breastfeeding woman

Related Conditions & MeSH terms

• Gonorrhea
• Neisseria Gonorrhoeae Infection

Intervention

Other:
• Absence of antibiotic treatment
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)

Drug:
• Ceftriaxone
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)		3 months after inclusion
Secondary	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
Secondary	Proportion of patients with negative pharyngeal NG cultures		at 3 months after inclusion
Secondary	Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)	Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample	at 1 month after inclusion
Secondary	Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae	Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample	at 1 month after inclusion
Secondary	Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)	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	at 3 months after inclusion
Secondary	Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae	Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample	at 3 months after inclusion
Secondary	Proportion of patients with spontaneous pharyngeal clearance of NG	Analysis of 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	at 1 month after inclusion
Secondary	Proportion of patients with spontaneous pharyngeal clearance of NG	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	at 3 months after inclusion
Secondary	Proportion of partners with NAAT positive for NG	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)	At inclusion of the partner
Secondary	Proportion of partners with NG cultures positive	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)	At inclusion of the partner
Secondary	Proportion of partners with NAAT positive for NG	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)	at 1 month after inclusion of the partner
Secondary	Proportion of partners with NG cultures positive	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)	at 1 month after inclusion of the partner
Secondary	Proportion of partners with NAAT positive for NG	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)	at 3 months after inclusion of the partner
Secondary	Proportion of partners with NG cultures positive	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)	at 3 months after inclusion of the partner
Secondary	Proportion of identical genome between partner and patient		Up to 3 months
Secondary	Proportion of patients with Resistant NG strains		Up to 3 months
Secondary	Proportion of partners with Resistant NG strains		Up to 3 months
Secondary	Proportion of adverse events		Up to 3 months