Prospectively investigate whether ciprofloxacin, administered as antibiotic prophylaxis in patients treated for haematological malignancies (with or without gastro-intestinal mucositis), in the currently recommended dosing regimen (500 mg orally or…
ID
Source
Brief title
Condition
- Leukaemias
- Bacterial infectious disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
PK/PD target attainment defined as AUC0-24/MIC * 125.
Secondary outcome
PK/PD target attainment defined as peak concentration (Cmax)/MIC * 8.
PK/PD target attainment defined as the unbound ciprofloxacin concentration
(fAUC0-24)/MIC * 90.
To analyze the amount of positive cultures with ciprofloxacin-resistant
bacteria or extended-spectrum *-lactamases (ESBL)-producing Gram-negative
bacteria in patients treated for haematological malignancies, who received
ciprofloxacin as infection prophylaxis.
Background summary
To prevent infections caused by commensal bacteria of the intestinal tract in
patients treated for haematological malignancies, during profound and
protracted neutropenia, ciprofloxacin as antibiotic prophylaxis is recommended.
Although pharmacokinetics of antibiotics are likely to be changed by altered
drug absorption due to adverse effects of cytostatic agents, like mucositis,
diarrhea and vomiting and changes in distribution, metabolism and excretion,
pharmacokinetic(PK) / pharmacodynamic(PD) target attainment has never been
investigated. Underdosing of ciprofloxacin could threaten these patients,
leading to suboptimal antibiotic prophylaxis, with negative effects on
patient*s outcome. Analyzing PK/PD target attainment is an accepted strategy to
investigate the efficacy of the used dosing regimen.
Study objective
Prospectively investigate whether ciprofloxacin, administered as antibiotic
prophylaxis in patients treated for haematological malignancies (with or
without gastro-intestinal mucositis), in the currently recommended dosing
regimen (500 mg orally or 400 mg intravenously twice a day or another dose,
which is adjusted to renal function), results in the PK/PD target attainment of
AUC0-24/MIC * 125.
Study design
Prospective, observational, single-center cohort study.
Study burden and risks
Risks imposed by participation are considered negligible.
By using population pharmacokinetic (PK) modeling, individual relevant
pharmacokinetic parameters can be assessed on the basis of only 4 blood samples
per patient. As a result, the participation burden and risk for the individual
patient is low. Participation itself does not bring any benefit, but the group
related benefit could be significant, based on substantial morbidity and
mortality associated with bacterial infections in this vulnerable patient
population, that could be prevented by efficient ciprofloxacin prophylaxis.
Meibergdreef 9
Amsterdam Zuidoost 1105 AZ
NL
Meibergdreef 9
Amsterdam Zuidoost 1105 AZ
NL
Listed location countries
Age
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
Design
Recruitment
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 |
|---|---|
| CCMO | NL67783.018.18 |