Efficacy of Temocillin compared to standard of care in the Treatment of Neisseria gonorrhoeae Infections: A Multicenter Randomized Controlled Non-Inferiority Trial (TEMtoGo).

Status Authorised, recruitment pending · 1 EU/EEA countries · 11 sites · Protocol APHP251262

Overview

Sponsor-declared trial summary

Phase Therapeutic confirmatory (Phase III)

Status Authorised, recruitment pending

Participants planned 360

Countries 1

Sites 11

Neisseria gonorrhoeae Infections

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 D21 (negative PCR in urine/vagina, throat and/or anus).

Key facts

Sponsor: Assistance Publique Hopitaux De Paris
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Decision date (initial): 2026-05-18
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: No
Funding sources: Ministry of Health / DGOS- RECHMIE-24-0004

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

Secondary objectives 6

To compare each experimental treatment to the SOC in terms of: - Efficacy of treatments for Ng infections at D21, according to the infected site (negative PCR in urine/vagina, throat or anus).
- Safety
- Patient satisfaction/perception.
- Impact of the different antimicrobial therapies on ESBL-E rectal carriage rate at D1, D21 and M3
- Impact of the different antimicrobial therapies on throat/anal and urine/vagina microbiota at D1, D21 and M3
- Population of Ng selected under treatment: MIC determination to ceftriaxone and temocillin, genotype, clonality and resistance determinants (sequence type (ST), resistance genes).

Conditions and MedDRA coding

Neisseria gonorrhoeae Infections

Version	Level	Code	Term	System organ class
21.1	PT	10081185	Gonococcal infection	100000004862
20.0	SOC	10021881	Infections and infestations	1

Study design 1 period

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Phase III confirmatory multicenter, randomized, controlled, open-label non-inferiority trial with three parallel arms	Randomised Controlled	None		Arm1 - ceftriaxone (SOC): patients will receive a single 1 g dose of IM ceftriaxone (SOC) after reconstitution with 4 mL of lidocaine at 10 mg/mL to prevent pain at the injection site. Arm2 - IM temocillin: patients will receive a single 2 g dose of IM temocillin after reconstitution with 4 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. Arm3 - IV temocillin: 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 bolus, 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.

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1- Age ≥ 18 years
2- Positive PCR for Ng (urine/vagina and/or throat and/or anus)
3-Asymptomatic Neisseria gonorrhoeae infection
4- Patient who has understood the entirety of the study and accepts its constraints
5-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.
6- Signature of the consent form for participation in the trial.
7- 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)
8- French, English or Spanish speaker

Exclusion criteria 16

1 - Known allergy to penicillin, temocillin, ceftriaxone or other beta-lactam antibiotics (grade 3 or 4), or lidocaine
2- Known complete heart block
3- Known hypersensitivity to lidocaine or other amide-type anesthetics
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> 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 at baseline)
10 -Known renal or hepatic dysfunction
11 - Patient on curative anticoagulation or known hemostasis 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…)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Proportion of participants with therapeutic success at D21. Therapeutic success is defined by a negative PCR for Ng at all three sites (urine/vagina, throat and anus) at D21 of treatment.

Secondary endpoints 6

- Proportion of participants with therapeutic success at D21 according to each infected site urine/vagina, throat or anus). Therapeutic success is defined by a negative PCR for the infection site at day 21 of treatment.
- Incidence of clinical and biological adverse effects (AEs), grade 3 or 4 AEs, all-grade AEs, treatment-related adverse events (all grades), study discontinuations due to AEs, and serious adverse events at M3.
- Satisfaction/perception evaluated by the patient at baseline (D1, after injection) and D21 (5 questions asked during consultation)
- Proportion of ESBL-E rectal colonization at baseline (D1), D21, and M3
- Composition of the throat/anal and urine/vagina microbiota at D1, D21 and M3
- Ng populations, clonality, and analysis of resistance determinants (MIC, ST, resistance genes) at day 1 and D21.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Temocillin Sodium

SCP2020783 · ATC

Active substance: Temocillin Sodium
Route of administration: INTRAMUSCULAR INJECTION
Max daily dose: 2 g gram(s)
Max total dose: 2 g gram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J01CA17 — TEMOCILLIN
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Negaban 2 g poudre pour solution injectable/pour perfusion

PRD1955801 · Product

Active substance: Temocillin Sodium
Pharmaceutical form: SOLUTION FOR INJECTION/INFUSION
Route of administration: INTRAVENOUS ADMINISTRATION
Max daily dose: 2 g gram(s)
Max total dose: 2 g gram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J01CA17 — TEMOCILLIN
Marketing authorisation: 1999024938
MA holder: EUMEDICA / BELGIUM
MA country: Luxembourg
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 1

Ceftriaxone Sodium

SCP107121969 · ATC

Active substance: Ceftriaxone Sodium
Route of administration: INTRAMUSCULAR INJECTION
Max daily dose: 1 g gram(s)
Max total dose: 1 g gram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: J01DD04 — CEFTRIAXONE
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Assistance Publique Hopitaux De Paris

Sponsor organisation: Assistance Publique Hopitaux De Paris
Address: Porte 23, 1 Avenue Claude Vellefaux 1 Avenue Claude Vellefaux
City: Paris Cedex 10
Postcode: 75475
Country: France

Scientific contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Dr Laure SURGERS

Public contact point

Organisation: Assistance Publique Hopitaux De Paris
Contact name: Breno MELO, PhD

Locations

1 EU/EEA country · 11 investigational sites

By country

Country	MS status	Planned subjects	Sites
France	Authorised, recruitment pending	360	11
Rest of world	—	0	—