Target attainment of ciprofloxacin as infection prophylaxis during chemotherapy-induced neutropenia in patients treated for haematological malignancies.

Target attainment of ciprofloxacin as infection prophylaxis during chemotherapy-induced neutropenia in patients treated for haematological malignancies. - Target attainment of ciprofloxacin as infection prophylaxis.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON48253

Enrollment

Registered

2018-12-20

Start date

2019-03-04

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

haematological malignancies Infections

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
PK/PD target attainment defined as AUC0-24/MIC * 125.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results