Randomized, Multicenter, Non-inferiority Trial Comparing the Efficacy of Fosfomycin Versus Fluoroquinolones or Cotrimoxazole as Oral Follow-up Treatment in Febrile Urinary Tract Infections in Men Caused by Susceptible Enterobacteria (FOSFORMEN)
Essai randomisé, Multicentrique, de Non-infériorité Comparant l'efficacité d'un Traitement Par Fosfomycine Versus Fluoroquinolones ou Cotrimoxazole en Relais Oral Dans Les Infections Urinaires Masculines fébriles Dues à Escherichia Coli
The fosfomycin-trometamol (FT) combination demonstrates microbiological efficacy against the vast majority of Escherichia coli strains responsible for urinary tract infections (UTIs). Moreover, approximately 99% of strains exhibiting multidrug resistance remain suceptible to fosfomycin.
The clinical tolerance profile of this molecule is excellent and has been well established since its market authorization in 1989 for the treatment of cystitis in women.
Its pharmacokinetic and pharmacodynamic properties are compatible with its use in the treatment of UTIs in men.
However, the clinical efficacy of FT (oral fosfomycin) in the treatment of febrile UTIs in men has never been evaluated in prospective trials. FT could represent an innovative treatment option in such cases, offering the use if an antibiotic with significantly fewer side effects than those currently recommended.
The main objective of the trial is to demonstrate that FT is not inferior to fluoroquinolones (FQ) or cotrimoxazole (TMP-SMX) as oral step-down therapy in prostatitisfebrile male urinary tract infections caused by Escherichia coli.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 3단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Jérôme Lambert
- 전화번호: +33 +33 1 42 49 97 42
- 이메일: jerome.lambert@u-paris.fr
연구 연락처 백업
- 이름: Antoine Hamon
- 전화번호: +33 +33 1 40 87 54 83
- 이메일: antoine.hamon@aphp.fr
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Male
- Age ≥ 18
- Body temperature ≥ 38°C within the 72 hours preceding the diagnosis of UTI
- At least one of the following symptoms : dysuria, higher urinary frequency, urgency, hematuria, suprapubic pain, prostatic pain, or perineal pain
- Positive urine microbiological examination (urine culture) : Sample collected before initiation of the empiric antibiotic therapy, ≥ 10 leukocytes/µL, and monomicrobial culture positive for E. coli with bacteriuria ≥ 103 CFU/mL
- The strain must be suceptible to fosfomycin and to either FQ or TMP-SMX according to EUCAST
- The strain must be suceptible to the empiric antibiotic therapy received
- Ability to take oral treatment
- Favorable clinical evolution after receiving effective empiric antibiotic therapy for 72 ± 24 hours ; Favorable evolution is defined as body temperature < 38°C with clinical improvement or resolution of the clinical signs and symptoms of urinary tract infection present at diagnosis, including the absence or improvement of dysuria, pollakiuria, urinary urgency, hematuria, suprapubic, prostatic, or perineal pain, urethral pain during urination, and/or a burning sensation during urination.
Exclusion Criteria:
- Presence of another condition that could explain the fever
- Septic shock of urinary origin
- Need for a urological procedure
- Anatomical abnormalities of the urinary tract (e.g., urinary prostheses and implants [except JJ], Bricker, neobladder, total prostatectomy, uretrestomy, nephrostomy, urinary fistula)
- Presence of an indwelling urinary catheter, except of placed during the current UTI episode
- Neurogenic bladder
- Immunosupression
- Contraindication to the use of FQ , TMP-SMX or FT
- Severe chronic kidney disease with an estimated flomerular filtration rate < 20 mL/min
- UTI treated within the past 3 months
- High probability of death within 3 months
- Major cognitive disorders
- Patients deprived of their liberty by judicial or administrative decision, under guardianship or curatorship
- Lack of social security coverage
- Absence of written informed consent
- Participation in another interventional research protocol
- Absence of written informed consent
- Participation in another interventional research protocol
- Patients deprived of their liberty by a judicial or administrative decision
공부 계획
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디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Fosfomycin-trometamol (FT)
|
Oral dose : 3g Fosfomycin-trometamol once daily |
|
활성 비교기: Reference treatments as per the French SPLIF guidlines
|
Reference treatments will bet hose recommended by the French SPLIF guidlines :
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Clinical cure
기간: At day 26
|
Defined as body temperature < 38°C and absence of urinary tract infection symptoms, without the need for additional antibiotic therapy up to the primary evaluation on Day 26, which corresponds to 14 days after completion of a 12-day antibiotic treatment assigned by randomization. |
At day 26
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cumulative incidence of infectious and urological complications
기간: Up to day 40
|
Up to day 40
|
|
|
Adherence to treatment
기간: Up to day 40
|
Up to day 40
|
|
|
Occurence of adverse events related to anticiotics
기간: Up to day 40
|
Occurrence, nature, and severity of adverse events |
Up to day 40
|
|
Rectal carriage of phenotypically antibiotic-resistant Enterobacterales
기간: At day 26
|
Carriage of Enterobacterales resistant to FQ, TMP-SMX, fosfomycin, and third-generation cephalosporins on Day 26, i.e., 14 days after completion of the randomized antibiotic treatment Binary outcome |
At day 26
|
|
Rates of recurrence of febrile or non-febrile UTIs (relapse or reinfection)
기간: At day 40
|
Assessed on Day40, i.e., 28 days after completion of the randomized antibiotic treatment
|
At day 40
|
|
Number of patients who experienced treatment failure
기간: Up to day 40
|
Clinical and biological characteristics of patients who experienced treatment failure compared to those who were cured during the initial episode |
Up to day 40
|
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연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
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추가 정보
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추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- APHP240801
개별 참가자 데이터(IPD) 계획
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