febrile illness infectious disease
Conditions
Interventions
The exposure to ciprofloxacin and amoxicillin will be investigated separately
in two studies, using the same study design and procedure. Patients will
receive a single oral tablet of the study antib
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age *18 years Acute febrile illness, defined as a temperature *38.3 and in need of IV antibiotic therapy for an infection for which amoxicillin or ciprofloxacin are registered treatments 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the AUC, calculated after oral administration of ciprofloxacin and amoxicillin, which will be compared between the febrile and afebrile phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are the Cmax and Tmax, calculated after oral administration of ciprofloxacin and amoxicillin, which will be compared between the febrile and afebrile phase. In addition, the percentage of patients that achieve target attainment will be assessed in both phases. | — |
Countries
Netherlands
Outcome results
None listed