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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Claire Pintado, Dr contact

+33142494973

claire.pintado@aphp.fr

Jérôme Lambert, Dr contact

+33142499742

jerome.lambert@u-paris.fr

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 groups in NCT05971550
Study groupRoleWhat they receive
Patients : Absence of antibiotic treatmentExperimentalNot described
Receives: Other: Absence of antibiotic treatment
Patients : CeftriaxoneActive comparatorNot described
Receives: Drug: Ceftriaxone

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 3 months after inclusion

Secondary outcomes (18)
  1. 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

  2. Proportion of patients with negative pharyngeal NG cultures

    Measured: at 3 months after inclusion

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Proportion of identical genome between partner and patient

    Measured: Up to 3 months

  16. Proportion of patients with Resistant NG strains

    Measured: Up to 3 months

  17. Proportion of partners with Resistant NG strains

    Measured: Up to 3 months

  18. 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.

  1. First posted2 Aug 2023
  2. Study startSep 2023 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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)
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

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.

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