Exposure to orally administered antibiotics during the initial phase of infection in non-critically ill, febrile patients - EXPO-AB

Amsterdam UMC, location AMC0 个研究点目标入组 50 人开始时间: 2019年6月26日最近更新: 2019年11月25日

适应症

试验速览

暂无简介。

•Age =18 years Acute febrile illness, defined as a temperature =38.5 and in need of IV antibiotic therapy for an infection for which amoxicillin or ciprofloxacin are registered treatments
•Admitted to the internal medicine (including gastroenterology and pulmonology ward)
•Able to take oral medication, that is no abdominal pathology or history of abdominal pathology that may alter absorption (i.e. vomiting, mucositis, diarrhoea, malabsorption syndrome, former abdominal surgery affecting absorption)
•Able and willing to give informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 50
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Critically ill patients, admitted to the ICU, or infectious patients of the general ward who became critically ill and got transferred to the ICU during the research period.
•Comorbidity affecting absorption: hepatic impairment, i.e. active hepatitis, hepatic failure, liver cirrhosis or severe renal impairment (GFR <30),
•Neutropenic patients (neutrophil count <1000/µl) and patients treated with chemotherapy within 28 days prior to the study.
•Contraindications to use ciprofloxacin or amoxicillin
•o Ciprofloxacin: allergy to fluoroquinolones, concomitant administration of tizanidine
•o Amoxicillin: allergy to penicillins or proven allergy to another beta-lactam agent (e.g. cephalosporin, carbapenem or monobactam).
•Penicillin/fluoroquinolone treatment during the week prior to study enrolment
•History of alcohol and drug abuse.

发起方

Amsterdam UMC, location AMC