EUCTR2022-001832-27-SK招募中1 期
A Single Group Treatment, Phase 2 study to investigate Pharmacokinetics, Safety and Tolerability of Cefepime-Enmetazobactam administered by intra-venous infusion over 2 hours in Male or Female Participants from birth to less than 18 years of age hospitalized with complicated urinary tract infections (cUTI) including Acute Pyelonephritis (AP).EMA Decision number of Paediatric Investigation Plan: P/0093/2019.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Participant must be from birth to <18 years of age. Participants up to
- •2 months must have been born at term or preterm with a gestational age
- •=32 weeks.
- •2. Written informed consent from parent(s) or other legally acceptable
- •representative(s), and informed assent from participant (if age
- •appropriate according to local regulations).
- •3. If female and has reached menarche, or has reached Tanner stage 3
- •development, (even if not having reached menarche) the participant is
- •authorized to participate in this clinical study if the following criteria are
- •a) Participant has a negative urine and/or serum human chorionic
- •gonadotropin test at screening visit. As serum tests may miss an early
- •pregnancy, relevant menstrual history, and sexual history, including
- •methods of contraception, should be considered
- •b) Participant agrees to avoid conception from the time of screening
- •until 7 days after receipt of study intervention and agrees not to attempt
- •pregnancy from the time of screening until 7 days after EOT with study
- •intervention, and participant agrees to follow guidelines received regarding continuation of abstinence, initiation of abstinence or about
- •allowed contraception, and
- •c) Participant reports sexual abstinence for the prior 3 months or
- •reported the use of at least 1 of the acceptable methods of
- •contraception, including an intrauterine device (with copper banded
- •coil), levonorgestrel intrauterine system or regular
- •medroxyprogesterone injections, or participant agrees to initiate sexual
- •abstinence from the time of screening until 7 days after end of treatment
- •(EOT) with study intervention. For detailed information on contraceptive and barrier guidance, refer to Section 10.4
- •4. Participant has a clinically suspected and/or bacteriologically
- •documented complicated urinary tract infection (cUTI) or acute
- •pyelonephritis judged by the investigator to require the participant to be
- •hospitalized for treatment with intravenous (i.v.) therapy.
- •5. The causative pathogen is confirmed to be either susceptible to cefepime (if results available) or suspected to be susceptible
- •to cefepime-enmetazobactam, and the patient is suitable for treatment with cefepime according to the investigator judgement.
- •6. Participant has pyuria, defined as dipstick analysis positive for
- •leukocyte esterase OR:
- •a) If =1 year of age: White blood cell (WBC) count >10 cells/µL in
- •unspun urine or =10 cells/high power field in spun urine.
- •b) If <1 year of age: WBC count >5 cells/µL in unspun urine or =5
- •cells/high power field in spun urine.
- •7. Participant demonstrates clinical signs and/or symptoms of either
- •acute pyelonephritis or cUTI at the Screening Visit, as defined by the
- •following criteria:
- •a. For pyelonephritis, participants must have at least 2 of the following
- •new or worsening signs and/or symptoms:
- •i. If 0 to <2 years of age:
- •Fever (as defined by the investigator)
- •Failure to thrive
- •Recent weight loss
- •Irritability
- •Poor feeding
- •Lack of normal level of activity
- •Abdominal tenderness on physical examination
- 另有 11 项未显示
排除标准
- •1. History of serious allergy, hypersensitivity (e.g., anaphylaxis), or any
- •serious reaction to cefepime, any cephalosporin, penicillins, ß-lactamase
- •inhibitors (e.g., tazobactam, sulbactam, or clavulanic acid), or other ß-
- •lactam agents.
- •2. Previous enrolment in this study, or in another interventional study =
- •30 days before i.v. administration of study intervention.
- •3. Concurrent infection requiring systemic antibiotics in addition to the
- •i.v. study intervention therapy at the time of first study intervention
- •administration.
- •4. Receipt of systemic antibiotics within 24 hours before obtaining the
- •study qualifying pre-treatment baseline urine sample and before study
- •intervention therapy. Exceptions are:
- •Receipt up to 24 hours of short-acting antibacterial agent with a daily
- •dose not completed.
- •Patients who received prior antimicrobial therapy for the current
- •cUTI/AP, and 1) in the Investigator's opinion, failed that prior antibiotic
- •therapy (i.e., presented with worsening signs and symptoms), AND 2)
- •were documented that the pathogen is non-susceptible to the prior
- •antibiotic therapy.
- •Patients who have received antimicrobial prophylaxis for recurrent
- •cUTI and then presented signs and symptoms consistent with an active
- •new cUTI or AP.
- •5. A permanent indwelling bladder catheter or instrumentation
- •including nephrostomy or current urinary catheter or anticipation of
- •urinary catheter placement that would not be removed during the course
- •of i.v. study intervention therapy administration.
- •6. Participant has suspected or known complete obstruction of any
- •portion of the urinary tract, perinephric abscess, or ileal loops.
- •7. Participant has trauma to the pelvis or urinary tract.
- •8. Participant has undergone renal transplantation.
- •9. Participant has a condition or history of any illness that, in the
- •opinion of the investigator, would have made the participant unsuitable
- •for the study (e.g., may have confounded the results of the study or
- •posed additional risk in administering the study therapy to the
- •participant).
- •10. Participant is considered unlikely to survive the 6-week study
- •period or had a rapidly progressive illness, including septic shock, that
- •was associated with a high risk of mortality.
- •11. At the time of first study intervention administration, known
- •presence of a cUTI caused by pathogens resistant to Cefepime -
- •enmetazobactam.
- •12. Presence of any of the following clinically significant laboratory
- •abnormalities:
- •a. Haematocrit <25% or haemoglobin <8 g/dL (<80 g/L, <4.9 mmol/L)
- •for children = 1 month, or <13 g/dL (<130 g/L, <8.0 mmol/L) for
- •children < 1 month.
- •b. Serum alanine aminotransferase (ALT) or aspartate
- •aminotransferase (AST)>3 times the age-specific upper limit of normal
- •(ULN), or total bilirubin >2 times ULN (except known Gilbert's disease)
- •and Absolute Neutrophil count<1000/ mm3.
- 另有 7 项未显示
研究者
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