Efficacy of Temocillin Compared to Standard of Care in the Treatment of Neisseria Gonorrhoeae Infections (TEMTtoGo)
Efficacy of Temocillin Compared to Standard of Care in the Treatment of Neisseria Gonorrhoeae Infections : A Multicenter Randomized Controlled Non-Inferiority Trial
연구 개요
상태
개입 / 치료
- 다른: Rectal swab for ESBL-E and microbiota (Eswab)
- 의약품: Ceftriaxone 1 g intramuscular single dose with lidocaine (3,5ml)
- 다른: Rectal, throat, urine/vagina swab (Cobas/Panther and eswab)
- 다른: Blood samples: 1 EDTA (Ethylenediaminetetraacetic acid) (7 ml) and 1dry tube (7 ml)
- 의약품: Temocillin (NEGABAN®) 2 g intramuscular single dose with lidocaine (3ml)
- 의약품: Temocillin (NEGABAN®) 2 g intravenous with lidocaine (3ml)
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: Laure SURGERS, Doctor
- 전화번호: +33 01 71 97 01 19
- 이메일: laure.surgers@aphp.fr
연구 연락처 백업
- 이름: Béatrice BERçOT, Professor
- 전화번호: +33 01 42 38 50 96
- 이메일: beatrice.bercot@aphp.fr
연구 장소
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Paris, 프랑스, 75012
- Service des maladies infectieuses et tropicales, Hôpital Saint-Antoine, GHU AP-HP Sorbonne Université
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연락하다:
- Laure SURGERS, Doctor
- 전화번호: +33 01 71 97 01 19
- 이메일: laure.surgers@aphp.fr
-
연락하다:
- Thibault CHIARABINI, Doctor
- 전화번호: +33 01 49 28 23 91
- 이메일: thibault.chiarabini@aphp.fr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: 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
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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.
다른 이름들:
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
다른 이름들:
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.
다른 이름들:
The blood sample will be performed 15 min after IV administration and 60 min after IM administration.
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실험적: 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.
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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.
다른 이름들:
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.
다른 이름들:
The blood sample will be performed 15 min after IV administration and 60 min after IM administration.
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.
다른 이름들:
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실험적: 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.
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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.
다른 이름들:
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.
다른 이름들:
The blood sample will be performed 15 min after IV administration and 60 min after IM administration.
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.
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants with a negative PCR for NG at urine/vagina site
기간: Day 21
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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.
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Day 21
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants with a negative PCR for NG at throat site
기간: Day 21
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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.
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Day 21
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Proportion of participants with a negative PCR for NG at anus site
기간: Day 21
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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.
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Day 21
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Proportion of participants with therapeutic success at day 21 for urine/vagina infection.
기간: Day 21
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The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
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Day 21
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Proportion of participants with therapeutic success at day 21 for throat infection.
기간: Day 21
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The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
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Day 21
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Proportion of participants with therapeutic success at day 21 for anus infection.
기간: at Day 21
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The proportion of participants with a negative PCR for the infection site at day 21 of treatment.
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at Day 21
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Number of clinical AE (adverse effects)
기간: Day 1 to Day 90
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the number of clinical adverse effects that are observed or felt by the patient within 90 days
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Day 1 to Day 90
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Number of biological adverse effects
기간: Day 1 to Day 90
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The number of biological adverse effects identified through laboratory test or biological measurements within 90 days
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Day 1 to Day 90
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Number of grade 3 or 4 AE
기간: Day 1 to Day 90
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the number of severe and life threatening adverse events within 90 days
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Day 1 to Day 90
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Number of all grade AEs
기간: Day 1 to Day 90
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the number of all grade adverse events within 90 days
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Day 1 to Day 90
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Number of treatment-related adverse events (all grade)
기간: Day 1 to Day 90
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the number of side effects judged by investigator to be caused by or linked to the experimental treatment within 90 days
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Day 1 to Day 90
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Number of study discontinuations due to AEs
기간: Day 1 to Day 90
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the number of patients who stop the study due to an adverse event within 90 days
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Day 1 to Day 90
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Number of serious adverse events
기간: Day 1 to Day 90
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the number of serious adverse events developped by patients within 90 days
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Day 1 to Day 90
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score of pain felt during the injection according to the Numerical Scale from 0 to 10
기간: Day 1 and Day 21
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Score of pain felt during the injection, evaluated by the patient in order to evaluate the patient satisfaction and perception
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Day 1 and Day 21
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Lickert score result regarding the speed of injection management
기간: Day 1 and Day 21
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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
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Day 1 and Day 21
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Lickert score result regarding the invasive perception of the management of the infection
기간: Day 1 and Day 21
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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
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Day 1 and Day 21
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Lickert score result regarding the comprehension of the patient that the antibiotic can only be administered by injection
기간: Day 1 and Day 21
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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
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Day 1 and Day 21
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Lickert score result regarding the perception of the patient that the injection was painful
기간: Day 1 and Day 21
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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
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Day 1 and Day 21
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Proportion of participants of ESBL-E rectal colonization
기간: Day 1, Day 21, and day 90
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Proportion of participants with rectal colonization by ESBL-producing Enterobacterales
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Day 1, Day 21, and day 90
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Composition of the throat microbiota
기간: Day 1, Day 21, and Day 90
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Analysis of the composition of the microbiota from throat samples at D1, D21, and D90 to assess changes over the study period.
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Day 1, Day 21, and Day 90
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Composition of the anal microbiota
기간: Day 1, Day 21, and Day 90
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Analysis of the composition of the microbiota from anal samples at D1, D21, and D90 to assess changes over the study period.
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Day 1, Day 21, and Day 90
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Composition of the urine/vagina microbiota
기간: Day 1, Day 21, and Day 90
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Analysis of the composition of the microbiota from urine/vagina samples at D1, D21, and D90 to assess changes over the study period.
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Day 1, Day 21, and Day 90
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Neisseria gonorrhoeae populations
기간: Day 1 and Day 21
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Analysis of Neisseria gonorrhoeae populations at D1 and D21.
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Day 1 and Day 21
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Neisseria gonorrhoeae clonality
기간: Day 1 and Day 21
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Analysis of Neisseria gonorrhoeae clonality at D1 and D21.
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Day 1 and Day 21
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Neisseria gonorrhoeae strains and resistance determinants
기간: Day 1 and Day 21
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Analysis of Neisseria gonorrhoeae resistance determinants, including minimum inhibitory concentrations (MIC), sequence types (ST), and resistance genes at D1 and D21.
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Day 1 and Day 21
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공동 작업자 및 조사자
수사관
- 수석 연구원: Laure SURGERS, Doctor, Assistance Publique - Hôpitaux de Paris
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
- 비뇨생식기 질환
- 생식기 질환
- 병리학적 과정
- 질병 속성
- 전염병
- 세균 감염
- 세균 감염 및 진균증
- 그람 음성 세균 감염
- 성병, 세균
- 나이세리아과 감염
- 병리학적 상태, 징후 및 증상
- 감염
- 성병
- 임질
- 황 화합물
- 유기 화학 물질
- 이종 사이 클릭 화합물
- 이종 사이 클릭 화합물, 2- 링
- 이종 사이 클릭 화합물, 융합 링
- 치료학
- 의약품 경로
- 약물 요법
- 환경 및 공중 보건
- 산, acyclic
- 카르 복실 산
- Anilides
- 아미드
- 아닐린 화합물
- 아민
- 아세타 닐리 드
- 미생물 학적 현상
- 비오타
- 생물 다양성
- 생태계
- 환경
- 생태 및 환경 현상
- 생물학적 현상
- 베타-락탐
- 락탐
- 세 팔로 스포린
- 티아 지인
- 아세테이트
- 에틸렌 디아민
- 디아 민
- 폴리아민
- 생식 및 비뇨기 생리 학적 현상
- 주사
- Cefotaxime
- Cephacetrile
- 요로 생리적 현상
- 투여, 점막
- 행정, 국소
- 리도카인
- 세프트리악손
- 에데틱산
- 주사, 근육 내
- 배뇨
- 관리, 직장
- 테모실린
- 미생물군집
기타 연구 ID 번호
- APHP251262
- 2025-524475-23-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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