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Efficacy of Temocillin compared to standard of care in the Treatment of Neisseria gonorrhoeae Infections: A Multicenter Randomized Controlled Non-Inferiority Trial (TEMtoGo).
EU CTIS ID: 2025-524475-23-00
What this study is testing
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).
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 1 - Known allergy to penicillin, temocillin, ceftriaxone or other beta-lactam antibiotics (grade 3 or 4), or lidocaine
- 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)
See the full eligibility criteria
- 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
- 1 - Known allergy to penicillin, temocillin, ceftriaxone or other beta-lactam antibiotics (grade 3 or 4), or lidocaine
- 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…)
- 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)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.