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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：Jérôme Lambert
- 電話番号：+33 +33 1 42 49 97 42
- メール：jerome.lambert@u-paris.fr
研究連絡先のバックアップ
- 名前：Antoine Hamon
- 電話番号：+33 +33 1 40 87 54 83
- メール：antoine.hamon@aphp.fr
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Fosfomycin-trometamol (FT)
|
Oral dose : 3g Fosfomycin-trometamol once daily |
|
アクティブコンパレータ：Reference treatments as per the French SPLIF guidlines
|
Reference treatments will bet hose recommended by the French SPLIF guidlines :
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Clinical cure
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cumulative incidence of infectious and urological complications
時間枠：Up to day 40
|
Up to day 40
|
|
|
Adherence to treatment
時間枠：Up to day 40
|
Up to day 40
|
|
|
Occurence of adverse events related to anticiotics
時間枠：Up to day 40
|
Occurrence, nature, and severity of adverse events |
Up to day 40
|
|
Rectal carriage of phenotypically antibiotic-resistant Enterobacterales
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- APHP240801
個々の参加者データ (IPD) の計画
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医薬品およびデバイス情報、研究文書
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