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

Conditions: Febrile illnesses

Registration Number: NL-OMON23093

Lead Sponsor: .A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

? Age =18 years
? Acute febrile illness, defined as an temperature =38.5 ?C and in need of IV antibiotic therapy for an infection for which amoxicillin or ciprofloxacin are registered treatments
? Admitted to the internal medicine ward (including pulmonology and gastroenterology)
? 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

Exclusion Criteria

? 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
? Pregnancy
? History of alcohol and drug abuse.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AUC (the area under the plasma concentration versus time curve) calculated after oral administration of ciprofloxacin and amoxicillin, which will be compared between the febrile and afebrile phase

Secondary Outcome Measures

Name	Time	Method
Cmax (the maximum plasma concentration) and Tmax (time to reach the maximum plasma concentration) of ciprofloxacin and amoxicillin, which will be compared between the febrile and afebrile phase. And, the PTA (probability of target attainment) with the administered dose. Ciprofloxacin has a concentration-dependent bacterial killing activity, with prolonged persistent effects and is thus dependent on maximizing plasma concentrations and the duration of time drug concentrations exceed the MIC, expressed in AUC/MIC. The PD target of total plasma concentrations is AUC/MIC =125. Amoxicillin has a time-dependent bacterial killing activity and is thus dependent on the duration of time that drug concentrations exceed the MIC, expressed as percentage of a dosing interval de concentrations exceeds the MIC, %fT>MIC. The PD target of total plasma concentrations is >50%fT>MIC