Neisseria Gonorrhoeae InfectionPhase 3PORTAPHARNCT05971550
Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study
A Phase 3 study testing Absence of antibiotic treatment and Ceftriaxone in people with Neisseria Gonorrhoeae Infection and Asymptomatic Pharyngeal Carriage, run by Assistance Publique - Hôpitaux de Paris.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neisseria Gonorrhoeae Infection, Asymptomatic Pharyngeal Carriage
- What is being tested?
- Absence of antibiotic treatment and Ceftriaxone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 254 participants
- Where
- No sites listed yet
- Study dates
- Sep 2023to Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the 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.
- Being tested
- Absence of antibiotic treatment, Ceftriaxone
- Medical subject headings
- Gonorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absence of antibiotic treatmentOther
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)
CeftriaxoneDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Patients : Absence of antibiotic treatment | Experimental | Not described Receives: Other: Absence of antibiotic treatment |
| Patients : Ceftriaxone | Active comparator | Not described Receives: Drug: Ceftriaxone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)
Measured: 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)
Measured: at 1 month after inclusion
Proportion of patients with negative pharyngeal NG cultures
Measured: at 3 months 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
Measured: 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
Measured: 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
Measured: 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
Measured: at 3 months after inclusion
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
Measured: 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 :
- 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: at 3 months after inclusion of the partner
Proportion of identical genome between partner and patient
Measured: Up to 3 months
Proportion of patients with Resistant NG strains
Measured: Up to 3 months
Proportion of partners with Resistant NG strains
Measured: Up to 3 months
Proportion of adverse events
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria Gonorrhoeae InfectionStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05971550
- Sponsor's protocol ID
- APHP210080
- Acronym
- PORTAPHAR
- Status last verified
- Feb 2023
- First submitted
- 14 Apr 2023
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study
- ClinicalTrials.gov ID
- NCT05971550
- Acronym / sponsor ID
- PORTAPHAR / APHP210080
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 254 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2023 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients : Absence of antibiotic treatment | Experimental | Other: Absence of antibiotic treatment |
| Patients : Ceftriaxone | Active comparator | Drug: Ceftriaxone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absence of antibiotic treatmentAbsence 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) | Other | Patients : Absence of antibiotic treatment |
| CeftriaxoneCeftriaxone 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 | Drug | Patients : Ceftriaxone |
Primary outcome
Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)
Time frame: 3 months after inclusion
18 secondary outcomes
Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) and a negative pharyngeal culture for Neisseria gonorrhoeae (NG)
Time frame: at 1 month after inclusion
Proportion of patients with negative pharyngeal NG cultures
Time frame: at 3 months after inclusion
Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)
Time frame: at 1 month after inclusion
Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae
Time frame: at 1 month after inclusion
Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)
Time frame: at 3 months after inclusion
Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae
Time frame: at 3 months after inclusion
Proportion of patients with spontaneous pharyngeal clearance of NG
Time frame: at 1 month after inclusion
Proportion of patients with spontaneous pharyngeal clearance of NG
Time frame: at 3 months after inclusion
Proportion of partners with NAAT positive for NG
Time frame: At inclusion of the partner
Proportion of partners with NG cultures positive
Time frame: At inclusion of the partner
Proportion of partners with NAAT positive for NG
Time frame: at 1 month after inclusion of the partner
Proportion of partners with NG cultures positive
Time frame: at 1 month after inclusion of the partner
Proportion of partners with NAAT positive for NG
Time frame: at 3 months after inclusion of the partner
Proportion of partners with NG cultures positive
Time frame: at 3 months after inclusion of the partner
Proportion of identical genome between partner and patient
Time frame: Up to 3 months
Proportion of patients with Resistant NG strains
Time frame: Up to 3 months
Proportion of partners with Resistant NG strains
Time frame: Up to 3 months
Proportion of adverse events
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Absence of antibiotic treatment and Ceftriaxone in people with Neisseria Gonorrhoeae Infection and Asymptomatic Pharyngeal Carriage, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Pintado, Dr (+33142494973, claire.pintado@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG) (time frame: 3 months after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.