Febrile illnesses
Conditions
Interventions
Subjects will receive a single oral dose of ciprofloxacin or amoxicillin in addition to the IV antibiotic treatment prescribed for their febrile illness during their initial phase of disease when they
Sponsors
N.A.
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactAnnemieke van den Broek
Amsterdam UMC, location AMC
Outcome results
None listed