Personalized Antibiotic Treatment in the Emergency Department: Panther Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 4
- 主要终点
- Feasibility of completing all clinical trial activities and follow-up
研究概览
简要总结
This pilot study will randomize 40 female patients with acute uncomplicated pyelonephritis to receive standard duration of therapy versus patient-directed antimicrobial duration (PDAD). The primary objectives of this pilot trial are to determine the feasibility and safety of conducting a full-scale multi-center randomized controlled trial.
详细描述
Following informed consent, patients will be randomized to receive 10 days of cephalexin or PDAD (minimum of 3 days of cephalexin followed by placebo once patient reports 24 hours of symptom resolution). Patients will be evaluated at day 1 in-person, then daily using a mobile cellphone application to assess acute uncomplicated pyelonephritis (AUP) symptoms and quality of life (QOL). Urine samples will be collected at in-person visits at day 1, 3 weeks, and 4 weeks. Study feasibility will be assessed through day 90.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females between 18 and 55 years of age
- •Diagnosis of acute uncomplicated pyelonephritis
- •Can be discharged home on oral antimicrobial treatment
- •Ability to provide written informed consent in English or Spanish
排除标准
- •Took antibiotics in the prior 48 hours
- •Insulin-dependent diabetes
- •End-stage liver disease
- •If the patient reports a penicillin allergy, and is deemed to be high-risk using the penicillin allergy clinical decision rule (PEN-FAST)
- •Serious allergy (e.g., angioedema, anaphylaxis) to the study medication or a similarly reported allergy to a cephalosporin
- •Known or identified hydronephrosis, obstruction, or abscess identified by emergency department ultrasound
- •Presence of a kidney stone
- •Pregnancy or lactation
- •Renal dysfunction (defined as creatinine clearance of less than 30 mL/min)
- •Renal transplantation
- •Complicated pyelonephritis (defined anatomical or functional abnormality of the urinary tract that predisposes to infection)
- •Need for additional antimicrobial therapy for a coexisting infection
- •Human immunodeficiency virus (HIV) infection, with either a recent (in the past 6 months) acquired immune deficiency syndrome-defining condition or a cluster of differentiation-4 (CD-4+) T lymphocyte count <200/mm^3
研究组 & 干预措施
Standard Duration Treatment
干预措施: Cephalexin (Drug)
Patient-directed antimicrobial duration (PDAD)
干预措施: Cephalexin or placebo (Drug)
结局指标
主要结局
Feasibility of completing all clinical trial activities and follow-up
时间窗: 90 days
Percentage of participants that complete all study activities and follow-up through 90 days
Feasibility of Completing All Clinical Trial Activities and Follow-up
时间窗: 90 days
Percentage of participants that complete all study activities and follow-up through 90 days
次要结局
- Additional health care visits with the chief complaint of urinary tract infection(30 days)
- Sustained clinical cure(30 days)
- Sustained microbiological cure(30 days)
- Clinical and microbiological cure rates after the end of treatment(15-21 days)
- Time to return to normal activities(30 days)
- Adverse event and side effect event rates(30 days)
- Sustained Clinical Cure(30 days)
- Sustained Microbiological Cure Defined as the Bacterial Pathogen Found at Trial Entry is Reduced to Fewer Than 10^3 Cfu/mL and no New Pathogen >10^3 Cfu/mL,(30 days)
- Clinical Cure Rate at the End of Treatment(15-21 days)
- Microbiological Cure Rate at End of Treatment Defined as Defined as the Bacterial Pathogen Found at Trial Entry is Reduced to Fewer Than 10^3 Cfu/mL and no New Pathogen >10^3 Cfu/mL,(Day 15-21)
- Additional Health Care Visits With the Chief Complaint of Urinary Tract Infection(90 days)
研究者
Brett A Faine
Clinical Associate Professor
University of Iowa