Target attainment of ciprofloxacin as infection prophylaxis during chemotherapy-induced neutropenia in patients treated for haematological malignancies.
Recruiting
- Conditions
- All patients receiving ciprofloxacin prophylaxis as standard care will be included, regardless of treatment with different cytostatic agents, regardless of the severity of adverse effects of the treatment (in particular mucositis) and regardless of the degree and duration of neutropenia, as long as ciprofloxacin is recommended as infection prophylaxis within the applied treatment protocol.
- Registration Number
- NL-OMON20490
- Lead Sponsor
- Amsterdam UMC - location Academic Medical Centre (AMC), University of Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
Inclusion Criteria
Hospitalized adult patients (age = 18 years) receiving ciprofloxacin as infection prophylaxis as part of standard care prescribed by the treating physician.
Exclusion Criteria
Four patient-groups will be excluded as they are known to exhibit altered pharmacokinetics of antibiotics: patients in the intensive care unit (ICU), all patients receiving renal replacement therapy (RRT), patients with cystic fibrosis (CF) and severely burned patients.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method AUC0-24/MIC= 125, in which all relevant commensal Gram-negative bacteria of the intestinal tract will be taken into account.
- Secondary Outcome Measures
Name Time Method Cmax/MIC = 8, and fAUC0-24/MIC = 90 based on an average unbound fraction of ciprofloxacin of 70% and analyze the frequency of positive cultures with ciprofloxacin-resistant organisms or ESBL-producing Gram-negative bacteria in patients treated for haematological malignancies.