Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients : Absence of antibiotic treatment | Experimental |
| |
| Patients : Ceftriaxone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG) | 3 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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 :
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 :
Partners (n=100) :
Partner Inclusion Criteria :
Partner non-inclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Claire Pintado, Dr | Contact | +33142494973 | claire.pintado@aphp.fr | |
| Jérôme Lambert, Dr | Contact | +33142499742 | jerome.lambert@u-paris.fr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
| 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 |
| 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 |
| 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 |
| Proportion of patients with spontaneous pharyngeal clearance of NG | Analysis of factors associated with spontaneous pharyngeal clearance of NG :
| at 1 month after inclusion |
| Proportion of patients with spontaneous pharyngeal clearance of NG | Analysis of the factors associated with spontaneous pharyngeal clearance of NG :
| at 3 months after inclusion |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Proportion of identical genome between partner and patient | Up to 3 months |
| Proportion of patients with Resistant NG strains | Up to 3 months |
| Proportion of partners with Resistant NG strains | Up to 3 months |
| Proportion of adverse events | Up to 3 months |
| ID | Term |
|---|---|
| D006069 | Gonorrhea |
| ID | Term |
|---|---|
| D016870 | Neisseriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided