Neisseria Gonorrhoeae (Ng) InfectionsPhase 3TEMtoGoNCT07631364
Efficacy of Temocillin Compared to Standard of Care in the Treatment of Neisseria Gonorrhoeae Infections
A Phase 3 study testing Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml), Rectal swab for ESBL-E and microbiota (Eswab) and Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml) in people with Neisseria Gonorrhoeae (Ng) Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Neisseria gonorrhoeae (Ng) infections are common and increasing in incidence. Treatment with a third generation cephalosporin, i.e ceftriaxone 1g, single dose, intramuscular (IM), is recommended as a first line treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neisseria Gonorrhoeae (Ng) Infections
- What is being tested?
- Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml), Rectal swab for ESBL-E and microbiota (Eswab) and Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Dec 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Positive PCR for Ng (urine/vagina and/or throat and/or anus)
- Asymptomatic Neisseria gonorrhoeae infection
- Patient who has understood the entirety of the study and accepts its constraints
- Women of child-bearing potential (i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile) who are sexually active have to apply a effective method of birth control*, throughout the study period and for 90 days following the last dose of study treatment.
- Signature of the consent form for participation in the trial.
- Affiliation with a Social Security scheme or State Medical Aid (AME) (waiver to exempt the necessity for patients to be affiliated with a such scheme)
- French, English or Spanish speaker
Who cannot join
- 1 - Known allergy to penicillin, temocillin, ceftriaxone or other beta-lactam antibiotics (grade 3 or 4) 2-Known complete heart block 3- Known hypersensitivity to lidocaine or other amide-type anaesthetics 4- Clinical suspicion of hypovolemia 5 - Concomitant antibiotic treatment to be started or in progress for another bacterial infection except for doxycycline as post exposure prophylaxis 6 - BMI (Body Mass Index)> 35 kg/m2 7 - Another ongoing antibiotic therapy < 1 month except for doxycycline as post exposure prophylaxis) 8 - Complicated upper genital infection 9 - Pregnant or breastfeeding woman (urinary βHCG (Beta Human Chorionic Gonadotropin) at baseline for patients with childbearing potential) 10 - Known renal or hepatic dysfunction 11 - Patient on curative anticoagulation or known haemostasis disorder (contraindication for the IM route) 12- Prior participation in this study 13 - Patient under legal guardianship 14 - Participation in another randomized trial or trial concerning a medicinal product or clinical investigation protocol concerning a medical device (<3 months) 15- patients deprived of liberty by judicial or administrative decision 16- Patients who are the investigator or any other member of the study team, or close relatives of the investigator or persons involved in the study (e.g., assistant physicians, pharmacists, nurses…)A woman is considered of childbearing potential (WOCBP), i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Service des maladies infectieuses et tropicales, Hôpital Saint-Antoine, GHU AP-HP Sorbonne Université
Paris, 75012
Laure SURGERS, Doctor, +33 01 71 97 01 19, laure.surgers@aphp.fr
Thibault CHIARABINI, Doctor, +33 01 49 28 23 91, thibault.chiarabini@aphp.fr
About this study
Official title: Efficacy of Temocillin Compared to Standard of Care in the Treatment of Neisseria Gonorrhoeae Infections : A Multicenter Randomized Controlled Non-Inferiority Trial
Neisseria gonorrhoeae (Ng) infections are common and increasing in incidence. Treatment with a third generation cephalosporin, i.e ceftriaxone 1g, single dose, intramuscular (IM), is recommended as a first line treatment. Ceftriaxone is a broad-spectrum antibiotic with high impact on the intestinal microbiota associated with the acquisition of multidrug-resistant bacteria, particularly extended spectrum beta lactamase producing Enterobacteracerales (ESBL-E). Among populations at high risk for sexually transmitted infections (STI), the colonization rate of ESBL-E is particularly high, up to 30%, implying (i) a risk of transmission within the community and (ii) a risk of infections caused by multidrug-resistant organisms, which are difficult to treat. Temocillin, a narrow-spectrum antibiotic is known for its low ecological impact, appears to be a highly promising option. Ng strains currently circulating in France appear to be sensitive to it. Thus, temocillin could be as effective as ceftriaxone to treat Ng infections while avoiding the deleterious impact of broad-spectrum β-lactams on the acquisition of multidrug-resistant bacteria by patients
Read the detailed description
Sexually transmitted infections (STIs) are a major global public health issue. Ng infections are highly prevalent, with 100,000 cases reported in Europe in 2023, over 50% in men who have sex with men (MSM). Globally, WHO (World Health Organization) estimated 82.4 million new cases in 2020 among individuals aged 15-49, with incidence rates of 19 per 1000 women and 23 per 1000 men.
In France, Ng infections have been rising since the 2000s, particularly in MSM, with positivity rates 5-6 times higher than in heterosexual men and 7 times higher than in heterosexual women. Infections are mostly asymptomatic (~95%), though urethritis, cervicitis, proctitis, arthritis, and disseminated infections can occur.
Ng rapidly develops antimicrobial resistance due to genetic plasticity. Multidrug-resistant strains have emerged globally, but in France nearly all strains remain ceftriaxone-sensitive, with only 0.2% resistant in 2022. Standard treatment is ceftriaxone 1 g IM, a critical antibiotic impacting microbiota, and the only effective current option. Vaccine development is ongoing: the Bexsero vaccine showed 22% efficacy in reducing infections, and Phase 1/2 trials of Ng-specific vaccines are underway. Vaccine hesitancy and heterogeneous coverage, even in high-risk populations such as HIV (Human Immunodeficiency Virus) positive MSM, may limit rapid impact.
Alternative therapies include antibiotic combinations and new agents such as zoliflodacin, though pharyngeal efficacy is lower and broad-spectrum use is limited due to resistance concerns. Repositioning antibiotics has been explored: gentamicin shows low microbiota impact but lower pharyngeal efficacy; fosfomycin is ineffective for Ng; carbapenems (ertapenem) are effective but reserved for multidrug-resistant cases; temocillin, a narrow-spectrum β-lactam, preserves microbiota and colonization resistance and may improve pharyngeal clearance when given IV (Intravenous) or IM. Patient-centered outcomes, including perceived care quality, speed, and pain, will be assessed using short satisfaction questionnaires.
The main objective of this study is to demonstrate the non-inferiority of 2g IV or IM temocillin treatment compared to the reference treatment with 1g IM ceftriaxone (Standard of Care (SOC)) for Neisseria gonorrhoeae infections at day 21 (negative PCR (Polymerase Chain Reaction) in urine/vagina, throat and/or anus).
The primary endpoint is the proportion of participants with therapeutic success at day 21.
The participants will be adults' patients consulting in the inclusion centers, having positive PCR for Ng (urine/vagina, throat or anus). We will focus on asymptomatic patients.
This trial will then have 3 arms: - Arm 1, patients will receive a single 1 g dose of IM ceftriaxone (SOC). -Arm 2, patients will receive a single 2 g dose of IM temocillin - Arm 3, patients will receive a single 2 g dose of IV temocillin.
The total duration of the study is planned to be 27 months, Follow-up visits will be scheduled at Day 21 and Day 90.
- Conditions
- Neisseria Gonorrhoeae (Ng) Infections
- Being tested
- Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml), Rectal swab for ESBL-E and microbiota (Eswab), Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml), Ceftriaxone 1 g intramuscular single dose with lidocaine (3,5ml), Rectal, throat, urine/vagina swab (Cobas/Panther and eswab)
- Keywords
- Neisseria gonorrhoeae, Gonorrhea, Sexually transmitted infections (STIs), Ceftriaxone, Temocillin, Pharyngeal gonorrhea, Multidrug-resistant bacteria
- Medical subject headings
- Infections, Gonorrhea, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml)Drug
Also called NEGABAN 2 g, Temocillin 2 g single dose, Temocillin intravenous injection, Temocillin 2 g IV single dose
patients will receive a single 2 g dose of IV temocillin diluted in 20 mL of water for injection. In this trial, we chose to test the IV route, as the classical intramuscular (IM) injection is often described as painful. We hypothesize that the IV route may be more comfortable for patients. Moreover, after administration of a 2 g IV a slow intravenous injection (over 3 to 4 minutes), the peak plasma concentration reaches approximately 220-250 mg/L, and temocillin concentrations remain detectable after 12 hours (the dosing interval) at around 15 mg/L. We hypothesize that this high plasma concentration could improve treatment of pharyngeal infection.
Rectal swab for ESBL-E and microbiota (Eswab)Other
Also called Rectal swab sample collection, Rectal swab for ESBL-producing, Enterobacterales screening, Rectal swab for microbiota analysis
consists of collecting a rectal specimen using a sterile eSwab system. The swab is gently inserted into the rectum and rotated to obtain a sample of rectal flora. The collected specimen is then placed in the transport medium and sent to the laboratory for microbiological analysis.
The sample is used to detect ESBL-producing Enterobacterales (ESBL-E) and to analyze the intestinal microbiota composition.
Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml)Drug
Also called Temocillin 2 g, Temocillin 2 g single dose, Temocillin intramuscular injection, Temocillin 2 g IM single dose
patients will receive a single 2 g dose of IM temocillin after reconstitution with 3 mL of lidocaine at 10 mg/mL to prevent pain at the injection site. A single 1 g dose of temocillin has been used for the treatment of N. gonorrhoeae infection (Reimer et al., 1985). We chose to use a single 2 g dose because penicillin MICs are increasing. For bacterial STIs, treatment is currently administered via the intramuscular route, which is the fastest and most practical method of antibiotic administration for outpatients.
Ceftriaxone 1 g intramuscular single dose with lidocaine (3,5ml)Drug
Also called Ceftriaxone intramuscular injection, Ceftriaxone 1 g IM single dose, Single-dose ceftriaxone (1 g)
patients will receive a single 1 g dose of IM ceftriaxone (SOC) after reconstitution with 3,5 mL of lidocaine at 10 mg/mL to prevent pain at the injection site
Rectal, throat, urine/vagina swab (Cobas/Panther and eswab)Other
Also called Rectal, throat, urine, and vaginal specimen collection, Cobas/Panther and eSwab sample collection, Multisite swab for microbiological and molecular analysis, Rectal, throat, urine, vaginal swab for pathogen detection
consists of collecting biological specimens from rectal, throat, urine, and vaginal sites using appropriate sterile collection devices, including eSwab systems and sample kits compatible with Cobas or Panther platforms.
Samples are collected according to standard clinical procedures and transported to the laboratory for microbiological and molecular analyses. These specimens are analyzed using automated diagnostic platforms (Cobas or Panther) and conventional microbiological methods to detect and identify microorganisms or pathogens present at the sampled sites.
Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml)Other
The blood sample will be performed 15 min after IV administration and 60 min after IM administration.
| Study group | Role | What they receive |
|---|---|---|
| A single 1 g dose of IM ceftriaxone | Active comparator | Patients will receive a single 1 g dose of IM ceftriaxone (SOC) after reconstitution with 3.5 mL of lidocaine at 10 mg/mL to prevent pain at the injection site Receives: Other: Rectal swab for ESBL-E and microbiota (Eswab); Drug: Ceftriaxone 1 g intramuscular single dose with lidocaine (3,5ml); Other: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab); Other: Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml) |
| A single 2 g dose of IM temocillin | Experimental | Patients will receive a single 2 g dose of IM temocillin after reconstitution with 3 m L of lidocaine at 10 mg/mL to prevent pain at the injection site. Receives: Other: Rectal swab for ESBL-E and microbiota (Eswab); Drug: Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml); Other: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab); Other: Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml) |
| A single 2 g dose of IV temocillin. | Experimental | Patients will receive a single 2 g dose of IV temocillin diluted in 20 mL of water for injection. Receives: Drug: Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml); Other: Rectal swab for ESBL-E and microbiota (Eswab); Other: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab); Other: Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with a negative PCR for NG at urine/vagina site
Proportion of participants with a negative PCR for NG at urine/vagina site in order to determine the therapeutic success at day 21. PCR for NG at all three sites (urine/vagina, throat and anus) needs to be negative.
Measured: Day 21
Secondary outcomes (24)
Proportion of participants with a negative PCR for NG at throat site
Proportion of participants with a negative PCR for NG at throat site in order to determine the therapeutic success at day 21. PCR for NG at all three sites (urine/vagina, throat and anus) needs to be negative.
Measured: Day 21
Proportion of participants with a negative PCR for NG at anus site
Proportion of participants with a negative PCR for NG at anus site in order to determine the therapeutic success at day 21. PCR for NG at all three sites (urine/vagina, throat and anus) needs to be negative.
Measured: Day 21
Proportion of participants with therapeutic success at day 21 for urine/vagina infection.
The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
Measured: Day 21
Proportion of participants with therapeutic success at day 21 for throat infection.
The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
Measured: Day 21
Proportion of participants with therapeutic success at day 21 for anus infection.
The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
Measured: at Day 21
Number of clinical AE (adverse effects)
the number of clinical adverse effects that are observed or felt by the patient within 90 days
Measured: Day 1 to Day 90
Number of biological adverse effects
The number of biological adverse effects identified through laboratory test or biological measurements within 90 days
Measured: Day 1 to Day 90
Number of grade 3 or 4 AE
the number of severe and life threatening adverse events within 90 days
Measured: Day 1 to Day 90
Number of all grade AEs
the number of all grade adverse events within 90 days
Measured: Day 1 to Day 90
Number of treatment-related adverse events (all grade)
the number of side effects judged by investigator to be caused by or linked to the experimental treatment within 90 days
Measured: Day 1 to Day 90
Number of study discontinuations due to AEs
the number of patients who stop the study due to an adverse event within 90 days
Measured: Day 1 to Day 90
Number of serious adverse events
the number of serious adverse events developped by patients within 90 days
Measured: Day 1 to Day 90
score of pain felt during the injection according to the Numerical Scale from 0 to 10
Score of pain felt during the injection, evaluated by the patient in order to evaluate the patient satisfaction and perception
Measured: Day 1 and Day 21
Lickert score result regarding the speed of injection management
Likert score result regarding the speed of injection management (Lickert scale scored from 1 to 5)in order to evaluate the patient satisfaction and perception
Measured: Day 1 and Day 21
Lickert score result regarding the invasive perception of the management of the infection
Lickert score result regarding the invasive perception of the management of the infection (Lickert scale scored from 1 to 5) in order to evaluate the patient satisfaction and perception
Measured: Day 1 and Day 21
Lickert score result regarding the comprehension of the patient that the antibiotic can only be administered by injection
Lickert score result regarding the comprehension of the patient that the antibiotic can only be administered by injection (Lickert scale scored from 1 to 5) in order to evaluate the patient satisfaction and perception
Measured: Day 1 and Day 21
Lickert score result regarding the perception of the patient that the injection was painful
Lickert score result regarding the comprehension of the patient that the antibiotic can only be administered by injection (Lickert scale scored from 1 to 5)in order to evaluate the patient satisfaction and perception
Measured: Day 1 and Day 21
Proportion of participants of ESBL-E rectal colonization
Proportion of participants with rectal colonization by ESBL-producing Enterobacterales
Measured: Day 1, Day 21, and day 90
Composition of the throat microbiota
Analysis of the composition of the microbiota from throat samples at D1, D21, and D90 to assess changes over the study period.
Measured: Day 1, Day 21, and Day 90
Composition of the anal microbiota
Analysis of the composition of the microbiota from anal samples at D1, D21, and D90 to assess changes over the study period.
Measured: Day 1, Day 21, and Day 90
Composition of the urine/vagina microbiota
Analysis of the composition of the microbiota from urine/vagina samples at D1, D21, and D90 to assess changes over the study period.
Measured: Day 1, Day 21, and Day 90
Neisseria gonorrhoeae populations
Analysis of Neisseria gonorrhoeae populations at D1 and D21.
Measured: Day 1 and Day 21
Neisseria gonorrhoeae clonality
Analysis of Neisseria gonorrhoeae clonality at D1 and D21.
Measured: Day 1 and Day 21
Neisseria gonorrhoeae strains and resistance determinants
Analysis of Neisseria gonorrhoeae resistance determinants, including minimum inhibitory concentrations (MIC), sequence types (ST), and resistance genes at D1 and D21.
Measured: Day 1 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study startSep 2026 (estimated)
- Primary completionOct 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neisseria Gonorrhoeae (Ng) InfectionsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laure SURGERS, Doctor, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631364
- Sponsor's protocol ID
- APHP251262
- Other IDs
- 2025-524475-23-00, 2025
- Acronym
- TEMtoGo
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Temocillin Compared to Standard of Care in the Treatment of Neisseria Gonorrhoeae Infections : A Multicenter Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07631364
- Acronym / sponsor ID
- TEMtoGo / APHP251262
- Conditions
- Neisseria Gonorrhoeae (Ng) Infections
- Keywords
- Neisseria gonorrhoeae, Gonorrhea, Sexually transmitted infections (STIs), Ceftriaxone, Temocillin, Pharyngeal gonorrhea, Multidrug-resistant bacteria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 8 Jun 2026 (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.
Neisseria gonorrhoeae (Ng) infections are common and increasing in incidence. Treatment with a third generation cephalosporin, i.e ceftriaxone 1g, single dose, intramuscular (IM), is recommended as a first line treatment. Ceftriaxone is a broad-spectrum antibiotic with high impact on the intestinal microbiota associated with the acquisition of multidrug-resistant bacteria, particularly extended spectrum beta lactamase producing Enterobacteracerales (ESBL-E). Among populations at high risk for sexually transmitted infections (STI), the colonization rate of ESBL-E is particularly high, up to 30%, implying (i) a risk of transmission within the community and (ii) a risk of infections caused by multidrug-resistant organisms, which are difficult to treat. Temocillin, a narrow-spectrum antibiotic is known for its low ecological impact, appears to be a highly promising option. Ng strains currently circulating in France appear to be sensitive to it. Thus, temocillin could be as effective as ceftriaxone to treat Ng infections while avoiding the deleterious impact of broad-spectrum β-lactams on the acquisition of multidrug-resistant bacteria by patients
Detailed description
Sexually transmitted infections (STIs) are a major global public health issue. Ng infections are highly prevalent, with 100,000 cases reported in Europe in 2023, over 50% in men who have sex with men (MSM). Globally, WHO (World Health Organization) estimated 82.4 million new cases in 2020 among individuals aged 15-49, with incidence rates of 19 per 1000 women and 23 per 1000 men.
In France, Ng infections have been rising since the 2000s, particularly in MSM, with positivity rates 5-6 times higher than in heterosexual men and 7 times higher than in heterosexual women. Infections are mostly asymptomatic (~95%), though urethritis, cervicitis, proctitis, arthritis, and disseminated infections can occur.
Ng rapidly develops antimicrobial resistance due to genetic plasticity. Multidrug-resistant strains have emerged globally, but in France nearly all strains remain ceftriaxone-sensitive, with only 0.2% resistant in 2022. Standard treatment is ceftriaxone 1 g IM, a critical antibiotic impacting microbiota, and the only effective current option. Vaccine development is ongoing: the Bexsero vaccine showed 22% efficacy in reducing infections, and Phase 1/2 trials of Ng-specific vaccines are underway. Vaccine hesitancy and heterogeneous coverage, even in high-risk populations such as HIV (Human Immunodeficiency Virus) positive MSM, may limit rapid impact.
Alternative therapies include antibiotic combinations and new agents such as zoliflodacin, though pharyngeal efficacy is lower and broad-spectrum use is limited due to resistance concerns. Repositioning antibiotics has been explored: gentamicin shows low microbiota impact but lower pharyngeal efficacy; fosfomycin is ineffective for Ng; carbapenems (ertapenem) are effective but reserved for multidrug-resistant cases; temocillin, a narrow-spectrum β-lactam, preserves microbiota and colonization resistance and may improve pharyngeal clearance when given IV (Intravenous) or IM. Patient-centered outcomes, including perceived care quality, speed, and pain, will be assessed using short satisfaction questionnaires.
The main objective of this study is to demonstrate the non-inferiority of 2g IV or IM temocillin treatment compared to the reference treatment with 1g IM ceftriaxone (Standard of Care (SOC)) for Neisseria gonorrhoeae infections at day 21 (negative PCR (Polymerase Chain Reaction) in urine/vagina, throat and/or anus).
The primary endpoint is the proportion of participants with therapeutic success at day 21.
The participants will be adults' patients consulting in the inclusion centers, having positive PCR for Ng (urine/vagina, throat or anus). We will focus on asymptomatic patients.
This trial will then have 3 arms: - Arm 1, patients will receive a single 1 g dose of IM ceftriaxone (SOC). -Arm 2, patients will receive a single 2 g dose of IM temocillin - Arm 3, patients will receive a single 2 g dose of IV temocillin.
The total duration of the study is planned to be 27 months, Follow-up visits will be scheduled at Day 21 and Day 90.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A single 1 g dose of IM ceftriaxone | Active comparator | Other: Rectal swab for ESBL-E and microbiota (Eswab), Drug: Ceftriaxone 1 g intramuscular single dose with lidocaine (3,5ml), Other: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab), Other: Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml)Patients will receive a single 1 g dose of IM ceftriaxone (SOC) after reconstitution with 3.5 mL of lidocaine at 10 mg/mL to prevent pain at the injection site |
| A single 2 g dose of IM temocillin | Experimental | Other: Rectal swab for ESBL-E and microbiota (Eswab), Drug: Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml), Other: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab), Other: Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml)Patients will receive a single 2 g dose of IM temocillin after reconstitution with 3 m L of lidocaine at 10 mg/mL to prevent pain at the injection site. |
| A single 2 g dose of IV temocillin. | Experimental | Drug: Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml), Other: Rectal swab for ESBL-E and microbiota (Eswab), Other: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab), Other: Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml)Patients will receive a single 2 g dose of IV temocillin diluted in 20 mL of water for injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Positive PCR for Ng (urine/vagina and/or throat and/or anus)
- Asymptomatic Neisseria gonorrhoeae infection
- Patient who has understood the entirety of the study and accepts its constraints
- Women of child-bearing potential (i.e. fertile, following menarche and until becoming post-menopaused unless permanently sterile) who are sexually active have to apply a effective method of birth control*, throughout the study period and for 90 days following the last dose of study treatment.
Key exclusion criteria (1 listed)
- 1 - Known allergy to penicillin, temocillin, ceftriaxone or other beta-lactam antibiotics (grade 3 or 4) 2-Known complete heart block 3- Known hypersensitivity to lidocaine or other amide-type anaesthetics 4- Clinical suspicion of hypovolemia 5 - Concomitant antibiotic treatment to be started or in progress for another bacterial infection except for doxycycline as post exposure prophylaxis 6 - BMI (Body Mass Index)> 35 kg/m2 7 - Another ongoing antibiotic therapy < 1 month except for doxycycline as post exposure prophylaxis) 8 - Complicated upper genital infection 9 - Pregnant or breastfeeding woman (urinary βHCG (Beta Human Chorionic Gonadotropin) at baseline for patients with childbearing potential) 10 - Known renal or hepatic dysfunction 11 - Patient on curative anticoagulation or known haemostasis disorder (contraindication for the IM route) 12- Prior participation in this study 13 - Patient under legal guardianship 14 - Participation in another randomized trial or trial concerning a medicinal product or clinical investigation protocol concerning a medical device (<3 months) 15- patients deprived of liberty by judicial or administrative decision 16- Patients who are the investigator or any other member of the study team, or close relatives of the investigator or persons involved in the study (e.g., assistant physicians, pharmacists, nurses…)A woman is considered of childbearing potential (WOCBP), i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient.
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 |
|---|---|---|
| Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml)Also: NEGABAN 2 g, Temocillin 2 g single dose, Temocillin intravenous injection, Temocillin 2 g IV single dosepatients will receive a single 2 g dose of IV temocillin diluted in 20 mL of water for injection. In this trial, we chose to test the IV route, as the classical intramuscular (IM) injection is often described as painful. We hypothesize that the IV route may be more comfortable for patients. Moreover, after administration of a 2 g IV a slow intravenous injection (over 3 to 4 minutes), the peak plasma concentration reaches approximately 220-250 mg/L, and temocillin concentrations remain detectable after 12 hours (the dosing interval) at around 15 mg/L. We hypothesize that this high plasma concentration could improve treatment of pharyngeal infection. | Drug | A single 2 g dose of IV temocillin. |
| Rectal swab for ESBL-E and microbiota (Eswab)Also: Rectal swab sample collection, Rectal swab for ESBL-producing, Enterobacterales screening, Rectal swab for microbiota analysisconsists of collecting a rectal specimen using a sterile eSwab system. The swab is gently inserted into the rectum and rotated to obtain a sample of rectal flora. The collected specimen is then placed in the transport medium and sent to the laboratory for microbiological analysis. The sample is used to detect ESBL-producing Enterobacterales (ESBL-E) and to analyze the intestinal microbiota composition. | Other | A single 1 g dose of IM ceftriaxone, A single 2 g dose of IM temocillin, A single 2 g dose of IV temocillin. |
| Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml)Also: Temocillin 2 g, Temocillin 2 g single dose, Temocillin intramuscular injection, Temocillin 2 g IM single dosepatients will receive a single 2 g dose of IM temocillin after reconstitution with 3 mL of lidocaine at 10 mg/mL to prevent pain at the injection site. A single 1 g dose of temocillin has been used for the treatment of N. gonorrhoeae infection (Reimer et al., 1985). We chose to use a single 2 g dose because penicillin MICs are increasing. For bacterial STIs, treatment is currently administered via the intramuscular route, which is the fastest and most practical method of antibiotic administration for outpatients. | Drug | A single 2 g dose of IM temocillin |
| Ceftriaxone 1 g intramuscular single dose with lidocaine (3,5ml)Also: Ceftriaxone intramuscular injection, Ceftriaxone 1 g IM single dose, Single-dose ceftriaxone (1 g)patients will receive a single 1 g dose of IM ceftriaxone (SOC) after reconstitution with 3,5 mL of lidocaine at 10 mg/mL to prevent pain at the injection site | Drug | A single 1 g dose of IM ceftriaxone |
| Rectal, throat, urine/vagina swab (Cobas/Panther and eswab)Also: Rectal, throat, urine, and vaginal specimen collection, Cobas/Panther and eSwab sample collection, Multisite swab for microbiological and molecular analysis, Rectal, throat, urine, vaginal swab for pathogen detectionconsists of collecting biological specimens from rectal, throat, urine, and vaginal sites using appropriate sterile collection devices, including eSwab systems and sample kits compatible with Cobas or Panther platforms. Samples are collected according to standard clinical procedures and transported to the laboratory for microbiological and molecular analyses. These specimens are analyzed using automated diagnostic platforms (Cobas or Panther) and conventional microbiological methods to detect and identify microorganisms or pathogens present at the sampled sites. | Other | A single 1 g dose of IM ceftriaxone, A single 2 g dose of IM temocillin, A single 2 g dose of IV temocillin. |
| Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml)The blood sample will be performed 15 min after IV administration and 60 min after IM administration. | Other | A single 1 g dose of IM ceftriaxone, A single 2 g dose of IM temocillin, A single 2 g dose of IV temocillin. |
Primary outcome
Proportion of participants with a negative PCR for NG at urine/vagina site
Time frame: Day 21
Proportion of participants with a negative PCR for NG at urine/vagina site in order to determine the therapeutic success at day 21. PCR for NG at all three sites (urine/vagina, throat and anus) needs to be negative.
24 secondary outcomes
Proportion of participants with a negative PCR for NG at throat site
Time frame: Day 21
Proportion of participants with a negative PCR for NG at anus site
Time frame: Day 21
Proportion of participants with therapeutic success at day 21 for urine/vagina infection.
Time frame: Day 21
Proportion of participants with therapeutic success at day 21 for throat infection.
Time frame: Day 21
Proportion of participants with therapeutic success at day 21 for anus infection.
Time frame: at Day 21
Number of clinical AE (adverse effects)
Time frame: Day 1 to Day 90
Number of biological adverse effects
Time frame: Day 1 to Day 90
Number of grade 3 or 4 AE
Time frame: Day 1 to Day 90
Number of all grade AEs
Time frame: Day 1 to Day 90
Number of treatment-related adverse events (all grade)
Time frame: Day 1 to Day 90
Number of study discontinuations due to AEs
Time frame: Day 1 to Day 90
Number of serious adverse events
Time frame: Day 1 to Day 90
score of pain felt during the injection according to the Numerical Scale from 0 to 10
Time frame: Day 1 and Day 21
Lickert score result regarding the speed of injection management
Time frame: Day 1 and Day 21
Lickert score result regarding the invasive perception of the management of the infection
Time frame: Day 1 and Day 21
Lickert score result regarding the comprehension of the patient that the antibiotic can only be administered by injection
Time frame: Day 1 and Day 21
Lickert score result regarding the perception of the patient that the injection was painful
Time frame: Day 1 and Day 21
Proportion of participants of ESBL-E rectal colonization
Time frame: Day 1, Day 21, and day 90
Composition of the throat microbiota
Time frame: Day 1, Day 21, and Day 90
Composition of the anal microbiota
Time frame: Day 1, Day 21, and Day 90
Composition of the urine/vagina microbiota
Time frame: Day 1, Day 21, and Day 90
Neisseria gonorrhoeae populations
Time frame: Day 1 and Day 21
Neisseria gonorrhoeae clonality
Time frame: Day 1 and Day 21
Neisseria gonorrhoeae strains and resistance determinants
Time frame: Day 1 and Day 21
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Individual participant dataSharing planned: No
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.
Laure SURGERS, Doctor principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml), Rectal swab for ESBL-E and microbiota (Eswab) and Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml) in people with Neisseria Gonorrhoeae (Ng) Infections, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. 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: opening soon, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laure SURGERS, Doctor (+33 01 71 97 01 19, laure.surgers@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a negative PCR for NG at urine/vagina site (time frame: Day 21). 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 22 Jun 2026.