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

Completed

Conditions: febrile illness
infectious disease
10002252

Registration Number: NL-OMON49236

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 50

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

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
<p>The primary endpoint is the AUC, calculated after oral administration of<br /><br>ciprofloxacin and amoxicillin, which will be compared between the febrile and<br /><br>afebrile phase. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints are the Cmax and Tmax, calculated after oral<br /><br>administration of ciprofloxacin and amoxicillin, which will be compared between<br /><br>the febrile and afebrile phase. In addition, the percentage of patients that<br /><br>achieve target attainment will be assessed in both phases.</p><br>