Target attainment of ciprofloxacin as infection prophylaxis during chemotherapy-induced neutropenia in patients treated for haematological malignancies.
Completed
- Conditions
- haematological malignanciesInfections1002432410004018
- Registration Number
- NL-OMON48253
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
Receiving ciprofloxacin orally or intravenously as prophylaxis as part of
standard care prescribed by the treating physician
Admitted to the nursing ward of the haematology department or to another
general ward, but treated for a haematological malignancy
Age * 18 years
Informed consent is obtained
Exclusion Criteria
Admitted to the Intensive Care Unit
Receiving RRT (i.e. haemodialysis, peritoneal dialysis, continuous venovenous
hemofiltration or another ways of RRT) during ciprofloxacin prophylaxis
Patients with cystic fibrosis
Severely burned patients, defined as a burned surface * 10%
Incapacitated patients, i.e. a minor or legally incompetent adult
Informed consent is not obtained
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>PK/PD target attainment defined as AUC0-24/MIC * 125.</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK/PD target attainment defined as peak concentration (Cmax)/MIC * 8.<br /><br>PK/PD target attainment defined as the unbound ciprofloxacin concentration<br /><br>(fAUC0-24)/MIC * 90.<br /><br>To analyze the amount of positive cultures with ciprofloxacin-resistant<br /><br>bacteria or extended-spectrum *-lactamases (ESBL)-producing Gram-negative<br /><br>bacteria in patients treated for haematological malignancies, who received<br /><br>ciprofloxacin as infection prophylaxis. </p><br>