The primary objective is to determine whether the exposure to oral ciprofloxacin and amoxicillin is altered in hospitalized non-critically ill, febrile patients in need of IV antibiotics when they are acutely ill and febrile, compared to when they…
ID
Source
Brief title
Condition
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Patients hospitalized with serious infectious diseases are in general initially
treated with parental antimicrobial therapy. In case of a favourable response
after 48-72h, intravenous (IV) antibiotic therapy is followed by an oral course
of antibiotic therapy. This switch to oral therapy has been shown to lower the
length of hospital stay, the risk of new infections and healthcare costs,
without compromising the clinical outcome. The initial treatment is
intravenously because of the high likelihood that adequate antibiotic plasma
levels are achieved when patients are acutely ill. It is possible that adequate
plasma concentrations are also achieved with oral antibiotics. If this is the
case, we might be able to obtain the evident benefits of oral therapy earlier
than the currently set time frame.
Study objective
The primary objective is to determine whether the exposure to oral
ciprofloxacin and amoxicillin is altered in hospitalized non-critically ill,
febrile patients in need of IV antibiotics when they are acutely ill and
febrile, compared to when they are afebrile. The secondary objective is to
determine whether target attainment can be achieved with current oral treatment
dosage regimens.
Study design
Longitudinal cohort study with repeated measurements
Intervention
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 antibiotic: when they are febrile and
again when they are afebrile, in addition to the antibiotic treatment
prescribed by the treating physician. To measure the antibiotic plasma
concentrations, blood samples will be obtained at 4 time points on both study
days.
Study burden and risks
Ciprofloxacin or amoxicillin will only be administered to those patients
diagnosed with a febrile illness for which the antibiotica are a registered
treatment and on top of IV antibiotics that are given to these patients. The
study will thus not influence the treatment of the febrile illness.
Prolongation of the hospitalization or extra study visits won*t be necessary.
Patients are exposed to extra venous blood sample collection (low-risk
intervention), with a total of 8 samples. To enhance patients comfort we will
try to collect the venous blood through an IV catheter. If this is not
possible, this will be done via direct venapuncture. Data obtained from our
study will have impact on current treatment strategies, which will be
beneficial for future patients, science and society.
Meibergdreef 9
Amsterdam 1105AZ
NL
Meibergdreef 9
Amsterdam 1105AZ
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-001240-21-NL |
| CCMO | NL69024.018.19 |