No registrations found.
ID
Source
Brief title
Health condition
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.
Sponsors and support
Intervention
Outcome measures
Primary outcome
AUC0-24/MIC≥ 125, in which all relevant commensal Gram-negative bacteria of the intestinal tract will be taken into account.
Secondary outcome
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.
Background summary
Prospectively investigate whether ciprofloxacin, administered as antibiotic prophylaxis in patients treated for haematological malignancies (with or without gastrointestinal mucositis), in the currently recommended dosing regimen (500mg orally twice a day, 400mg intravenously twice a day or another dose, which is adjusted to renal function), results in the PK/PD target attainment defined as AUC0-24/MIC ≥ 125.
Study objective
Exploratory study investigating the efficacy of the currently recommended dosing regimen of ciprofloxacin prophylaxis in patients treated for haematological malignancies.
Study design
Four venapunctures in a time period of 48 hours and one questionnaire about the frequency and consistency of the stools.
Intervention
No intervention in patient’s ‘treatment’ is made, intervention consists of four venapunctures in a time period of 48 hours, obtaining a maximum of 12 ml of blood in total and one questionnaire about the frequency and consistency of the stools.
Suzanne L. de Vroom
0031 (0)6 29189028
s.l.devroom@amc.uva.nl
Suzanne L. de Vroom
0031 (0)6 29189028
s.l.devroom@amc.uva.nl
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.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL7520 |
| Other | METC AMC : METC 2018_290 |