Efficacy of Temocillin Compared to Standard of Care in the Treatment of Neisseria Gonorrhoeae Infections

Starting soon · Phase 3

Conditions studied: Neisseria Gonorrhoeae (Ng) Infections

In brief

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

Key facts

Study ID: NCT07631364
Run by: Assistance Publique - Hôpitaux de Paris
People needed: 360
Starts: 2026-09-01
Expected to finish: 2028-12-01
Last updated by the study team: 2026-06-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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.

Where it is running

Service des maladies infectieuses et tropicales, Hôpital Saint-Antoine, GHU AP-HP Sorbonne Université — Paris, France

Full record on ClinicalTrials.gov

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