FOSFOLD - Fosfomycin trometamol compared with another active antibiotic relay therapy for the treatment of acute Escherichia coli pyelonephritis in elderly women: a randomized, multicenter, non-inferiority trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 20
- 主要终点
- Temperature <38°C and the absence of urinary infection symptoms between the end of treatment and the evaluation of the primary endpoint on Day 17, except for a value ≥38°C not related to the urine
研究概览
简要总结
Demonstrate the non-inferiority in terms of clinical cure of a treatment with FT compared to an alternative active antibiotic used as a follow-up treatment for Escherichia coli acute pyelonephritis in elderly women
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •75 years old or more
- •Temperature ≥38.0°C at least once within the 72 hours preceding the diagnosis.
- •At least one new symptom among the following: urgency, dysuria, increased frequency of urination, hematuria, burning during urination, pain in the lumbar region (spontaneous or provoked) or suprapubic area, urinary incontinence
- •A urine culture (ECBU) taken before the start of antibiotic therapy positive: ≥10,000 leukocytes/mL AND monomicrobial culture with E. coli ≥10^3 CFU/mL AND sensitivity to FT, to the empirical antibiotic therapy, and to at least one alternative antibiotic (active and not contraindicated) orally (fluoroquinolones, amoxicillin, or amoxicillin-clavulanic acid, SMX-TMP) or injectable if no oral alternative is available
- •Possibility of oral treatment intake
- •Favorable evolution after 3 or 4 days of effective empirical antibiotic therapy, defined as defervescence (temperature < 38°C) and improvement or resolution of the clinical signs of urinary tract infection present at diagnosis
排除标准
- •Presence of an infectious focus other than urinary
- •Absence of the patient's written consent or, in case the patient is unable to give consent, the absence of agreement from the trusted person or a close relative
- •Patient included in another interventional research protocol
- •Severity and/or initial complications of the infection: septic shock, need for urgent intervention on the upper urinary tract, renal abscess
- •Indwelling urinary catheter, bladder, ureteral, or nephrostomy catheter
- •Oral medication intake impossible
- •Immunosuppression (organ transplant recipient, immunosuppressive treatment, ongoing chemotherapy)
- •Allergy/contraindication to fosfomycin
- •End-stage chronic renal failure with a glomerular filtration rate <15 ml/min/1.73 m²
- •Absence of social security coverage
- •Patient under legal protection
研究组 & 干预措施
PIPERACILLIN AND BETA-LACTAMASE INHIBITOR
干预措施: PIPERACILLIN AND BETA-LACTAMASE INHIBITOR (Drug)
FOSFOMYCINE ARROW 3 g, granulés pour solution buvable en sachet
干预措施: FOSFOMYCINE ARROW 3 g, granulés pour solution buvable en sachet (Drug)
IMIPENEM AND CILASTATIN
干预措施: IMIPENEM AND CILASTATIN (Drug)
SULFAMETHOXAZOLE AND TRIMETHOPRIM
干预措施: SULFAMETHOXAZOLE AND TRIMETHOPRIM (Drug)
AMOXICILLIN AND BETA-LACTAMASE INHIBITOR
干预措施: AMOXICILLIN AND BETA-LACTAMASE INHIBITOR (Drug)
CEFEPIME
干预措施: CEFEPIME (Drug)
CEFOXITIN
干预措施: CEFOXITIN (Drug)
AZTREONAM
干预措施: AZTREONAM (Drug)
CIPROFLOXACIN
干预措施: CIPROFLOXACIN (Drug)
AMIKACIN
干预措施: AMIKACIN (Drug)
ERTAPENEM
干预措施: ERTAPENEM (Drug)
CEFOTAXIME
干预措施: CEFOTAXIME (Drug)
CEFTAZIDIME
干预措施: CEFTAZIDIME (Drug)
GENTAMICIN
干预措施: GENTAMICIN (Drug)
OFLOXACIN
干预措施: OFLOXACIN (Drug)
TEMOCILLIN
干预措施: TEMOCILLIN (Drug)
CEFTRIAXONE
干预措施: CEFTRIAXONE (Drug)
AMOXICILLIN
干预措施: AMOXICILLIN (Drug)
MEROPENEM
干预措施: MEROPENEM (Drug)
LEVOFLOXACIN
干预措施: LEVOFLOXACIN (Drug)
结局指标
主要结局
Temperature <38°C and the absence of urinary infection symptoms between the end of treatment and the evaluation of the primary endpoint on Day 17, except for a value ≥38°C not related to the urine
Temperature <38°C and the absence of urinary infection symptoms between the end of treatment and the evaluation of the primary endpoint on Day 17, except for a value ≥38°C not related to the urine
Absence of resumption of an antibiotic therapy active against the bacteria responsible for acute pyelonephritis following the end of antibiotic treatment
Absence of resumption of an antibiotic therapy active against the bacteria responsible for acute pyelonephritis following the end of antibiotic treatment
次要结局
- Rate of rectal colonization with antibiotic-resistant Enterobacteriaceae (FQ, SMX-TMP, fosfomycin, and third-generation cephalosporins) between day 1 and day 37
- Incidence of infectious and urological complications, evaluated at the end of antibiotic therapy (day 7): • Renal abscess • Need for urinary drainage • Transfer to continuous care or intensive care related to the infection
- - Occurrence, nature, and severity of adverse events related to antibiotics, measured by the National Cancer Institute's Common Terminology Criteria for Adverse Events scale
- Geriatric complications: • Occurrence of confusion (definition according to the CAM tool) • Fall(s) • Weight loss: evaluated as a percentage between the admission weight and the discharge weight or at day 17 if the patient is still hospitalized • Appearance of pressure ulcers
- Functional autonomy according to the A.D.L. scale at the end of follow-up on day 37
- Cumulative incidence of febrile or non-febrile UTI recurrence (recurrence or reinfection) between day 17 and day 37: • Cystitis: reappearance of urinary functional signs without fever with a positive urine culture • Pyelonephritis (PNA): reappearance of urinary functional signs with fever and a positive urine culture • Reinfection: new infection caused by a different bacterium than the initial episode • Recurrence: new infection caused by the same bacterium as the initial episode
- Rate of (re)hospitalization following the management of pyelonephritis (PNA)
- Number of days of hospitalization post-randomization
- Mortality at day 37
研究者
Clara Pouchelon
Scientific
Assistance Publique Hopitaux De Paris