Exploratory study investigating the efficacy of the currently recommended dosing regimen of ciprofloxacin prophylaxis in patients treated for haematological malignancies.
ID
Bron
Verkorte titel
Aandoening
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.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
AUC0-24/MIC≥ 125, in which all relevant commensal Gram-negative bacteria of the intestinal tract will be taken into account.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Exploratory study investigating the efficacy of the currently recommended dosing regimen of ciprofloxacin prophylaxis in patients treated for haematological malignancies.
Onderzoeksopzet
Four venapunctures in a time period of 48 hours and one questionnaire about the frequency and consistency of the stools.
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Suzanne L. de Vroom
0031 (0)6 29189028
s.l.devroom@amc.uva.nl
Wetenschappers
Suzanne L. de Vroom
0031 (0)6 29189028
s.l.devroom@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Hospitalized adult patients (age ≥ 18 years) receiving ciprofloxacin as infection prophylaxis as part of standard care prescribed by the treating physician.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7520 |
| Ander register | METC AMC : METC 2018_290 |