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

1 czerwca 2026 zaktualizowane przez: Assistance Publique - Hôpitaux de Paris

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

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

360

Faza

  • Faza 3

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Francja
      • Paris, Francja, 75012
        • Service des maladies infectieuses et tropicales, Hôpital Saint-Antoine, GHU AP-HP Sorbonne Université
        • Kontakt:
        • Kontakt:

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion 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

Exclusion Criteria:

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: A single 1 g dose of IM ceftriaxone
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
Inny: Rectal swab for ESBL-E and microbiota (Eswab)

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.

Inne nazwy:
  • Rectal swab sample collection
  • Rectal swab for ESBL-producing
  • Enterobacterales screening
  • Rectal swab for microbiota analysis
  • Rectal eSwab sampling
  • Rectal specimen collection for ESBL-E detection
  • Rectal swab culture for ESBL-E
  • Rectal swab for bacterial colonization assessment
Lek: Ceftriaxone 1 g intramuscular single dose with lidocaine (3,5ml)
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
Inne nazwy:
  • Ceftriaxone intramuscular injection
  • Ceftriaxone 1 g IM single dose
  • Single-dose ceftriaxone (1 g)
Inny: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab)

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.

Inne nazwy:
  • 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
Inny: 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.
Eksperymentalny: A single 2 g dose of IM temocillin
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.
Inny: Rectal swab for ESBL-E and microbiota (Eswab)

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.

Inne nazwy:
  • Rectal swab sample collection
  • Rectal swab for ESBL-producing
  • Enterobacterales screening
  • Rectal swab for microbiota analysis
  • Rectal eSwab sampling
  • Rectal specimen collection for ESBL-E detection
  • Rectal swab culture for ESBL-E
  • Rectal swab for bacterial colonization assessment
Inny: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab)

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.

Inne nazwy:
  • 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
Inny: 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.
Lek: Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml)
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.
Inne nazwy:
  • Temocillin 2 g single dose
  • Single-dose temocillin (2 g)
  • Temocillin 2 g
  • Temocillin intramuscular injection
  • Temocillin 2 g IM single dose
Eksperymentalny: A single 2 g dose of IV temocillin.
Patients will receive a single 2 g dose of IV temocillin diluted in 20 mL of water for injection.
Inny: Rectal swab for ESBL-E and microbiota (Eswab)

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.

Inne nazwy:
  • Rectal swab sample collection
  • Rectal swab for ESBL-producing
  • Enterobacterales screening
  • Rectal swab for microbiota analysis
  • Rectal eSwab sampling
  • Rectal specimen collection for ESBL-E detection
  • Rectal swab culture for ESBL-E
  • Rectal swab for bacterial colonization assessment
Inny: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab)

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.

Inne nazwy:
  • 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
Inny: 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.
Lek: Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml)
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.
Inne nazwy:
  • NEGABAN 2 g
  • Temocillin 2 g single dose
  • Temocillin intravenous injection
  • Temocillin 2 g IV single dose
  • Single-dose temocillin (2 g)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of participants with a negative PCR for NG at urine/vagina site
Ramy czasowe: 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.
Day 21

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion of participants with a negative PCR for NG at throat site
Ramy czasowe: Day 21
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.
Day 21
Proportion of participants with a negative PCR for NG at anus site
Ramy czasowe: Day 21
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.
Day 21
Proportion of participants with therapeutic success at day 21 for urine/vagina infection.
Ramy czasowe: Day 21
The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
Day 21
Proportion of participants with therapeutic success at day 21 for throat infection.
Ramy czasowe: Day 21
The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
Day 21
Proportion of participants with therapeutic success at day 21 for anus infection.
Ramy czasowe: at Day 21
The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
at Day 21
Number of clinical AE (adverse effects)
Ramy czasowe: Day 1 to Day 90
the number of clinical adverse effects that are observed or felt by the patient within 90 days
Day 1 to Day 90
Number of biological adverse effects
Ramy czasowe: Day 1 to Day 90
The number of biological adverse effects identified through laboratory test or biological measurements within 90 days
Day 1 to Day 90
Number of grade 3 or 4 AE
Ramy czasowe: Day 1 to Day 90
the number of severe and life threatening adverse events within 90 days
Day 1 to Day 90
Number of all grade AEs
Ramy czasowe: Day 1 to Day 90
the number of all grade adverse events within 90 days
Day 1 to Day 90
Number of treatment-related adverse events (all grade)
Ramy czasowe: Day 1 to Day 90
the number of side effects judged by investigator to be caused by or linked to the experimental treatment within 90 days
Day 1 to Day 90
Number of study discontinuations due to AEs
Ramy czasowe: Day 1 to Day 90
the number of patients who stop the study due to an adverse event within 90 days
Day 1 to Day 90
Number of serious adverse events
Ramy czasowe: Day 1 to Day 90
the number of serious adverse events developped by patients within 90 days
Day 1 to Day 90
score of pain felt during the injection according to the Numerical Scale from 0 to 10
Ramy czasowe: Day 1 and Day 21
Score of pain felt during the injection, evaluated by the patient in order to evaluate the patient satisfaction and perception
Day 1 and Day 21
Lickert score result regarding the speed of injection management
Ramy czasowe: Day 1 and Day 21
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
Day 1 and Day 21
Lickert score result regarding the invasive perception of the management of the infection
Ramy czasowe: Day 1 and Day 21
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
Day 1 and Day 21
Lickert score result regarding the comprehension of the patient that the antibiotic can only be administered by injection
Ramy czasowe: Day 1 and Day 21
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
Day 1 and Day 21
Lickert score result regarding the perception of the patient that the injection was painful
Ramy czasowe: Day 1 and Day 21
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
Day 1 and Day 21
Proportion of participants of ESBL-E rectal colonization
Ramy czasowe: Day 1, Day 21, and day 90
Proportion of participants with rectal colonization by ESBL-producing Enterobacterales
Day 1, Day 21, and day 90
Composition of the throat microbiota
Ramy czasowe: Day 1, Day 21, and Day 90
Analysis of the composition of the microbiota from throat samples at D1, D21, and D90 to assess changes over the study period.
Day 1, Day 21, and Day 90
Composition of the anal microbiota
Ramy czasowe: Day 1, Day 21, and Day 90
Analysis of the composition of the microbiota from anal samples at D1, D21, and D90 to assess changes over the study period.
Day 1, Day 21, and Day 90
Composition of the urine/vagina microbiota
Ramy czasowe: Day 1, Day 21, and Day 90
Analysis of the composition of the microbiota from urine/vagina samples at D1, D21, and D90 to assess changes over the study period.
Day 1, Day 21, and Day 90
Neisseria gonorrhoeae populations
Ramy czasowe: Day 1 and Day 21
Analysis of Neisseria gonorrhoeae populations at D1 and D21.
Day 1 and Day 21
Neisseria gonorrhoeae clonality
Ramy czasowe: Day 1 and Day 21
Analysis of Neisseria gonorrhoeae clonality at D1 and D21.
Day 1 and Day 21
Neisseria gonorrhoeae strains and resistance determinants
Ramy czasowe: Day 1 and Day 21
Analysis of Neisseria gonorrhoeae resistance determinants, including minimum inhibitory concentrations (MIC), sequence types (ST), and resistance genes at D1 and D21.
Day 1 and Day 21

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Assistance Publique - Hôpitaux de Paris

Śledczy

  • Główny śledczy: Laure SURGERS, Doctor, Assistance Publique - Hôpitaux de Paris

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 października 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

1 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

1 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

8 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

8 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 czerwca 2026

Ostatnia weryfikacja

1 maja 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • APHP251262
  • 2025-524475-23-00 (Ctis)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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