Probability of Optimal Target Attainment of Amikacin in Patients With Febrile Neutropenia During Treatment for a Hematological Disorder

NCT05689450 | Completed

• 1 other identifier: 2022-01218; am23Osthoff
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief Summary

The present trial is a single center, prospective, observational pharmacokinetics and pharmacodynamics (PKPD) cohort study investigating whether patients suffering from a hematological disorder and treated with amikacin due to febrile neutropenia (FN) achieve the predefined amikacin target concentration (Cmax ≥60 mg/L).

Conditions

Febrile Neutropenia (FN)

Keywords

Amikacin; Hematological disorder; Aminoglycoside (AG); Area under the curve (AUC); Acute kidney injury (AKI); Pharmacokinetics and pharmacodynamics (PKPD) analysis; Peak serum concentration (Cmax); Trough serum concentration (Cmin); Renal toxicity; Pharmacological target attainment; Amikacin concentration

Outcome Measures

Primary Outcomes (1)

• Change in pharmacological target attainment (Cmax ≥60 mg/L) in blood during amikacin treatment

  Percentage of patients with optimal pharmacological target attainment (Cmax ≥60 mg/L) in blood during amikacin treatment

  60 minutes (+/-30 minutes) and 8 hours (+/-1 hour) after the beginning of amikacin infusion on day 1, day 2 and day 3

Secondary Outcomes (5)

• AUC >200 mg/L and AUC >300 mg/L* h during amikacin treatment

  Up to 3 days after the beginning of amikacin infusion

• Percentage of patients achieving a calculated Cmin <4 mg/L in blood

  Up to 3 days after the beginning of amikacin infusion

• Incidence of Acute kidney injury (AKI)

  Within 7 days after application of amikacin

• Percentage of patients with optimal pharmacological target attainment

  Up to 3 days after the beginning of amikacin infusion

• Time interval between the detection of the first fever spike and the administration of amikacin

  One time assessment at baseline (Day 1)

Interventions

Data collection: Amikacin concentration OTHER

Blood samples for the measurement of the concentration and calculation of the AUC of amikacin are collected 60 min (+/-30 min) and 8 h (+/-1 h) after the beginning of amikacin infusion. The blood collection after the start of the amikacin infusion will be repeated during every subsequent amikacin administration, but max. during 3 consecutive days.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Inpatients being at risk of developing FN after treatment for a hematological disorder, admitted to the Department of Internal Medicine or the Department of Hematology at the University Hospital Basel (USB) and who are intended to receive amikacin iv during their hospital stay will be screened for eligibility.

You may qualify if:

• Age ≥ 18 years
• Informed consent (IC) as documented by signature
• Documented hematological disorder
• Hospitalization at the USB due to the treatment for a hematological disorder (e.g. chemotherapy, stem cell transplantation)
• Being at risk of developing FN during the hospital stay (e.g. because of chemotherapy)

You may not qualify if:

• Previous enrolment into the current study
• Outpatients
• Patients undergoing hemodialysis
• Women who are pregnant (special pharmacokinetic)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Division of Internal Medicine

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Febrile Neutropenia; Hematologic Diseases; Acute Kidney Injury

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hemic and Lymphatic Diseases; Leukocyte Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Michael Osthoff, PD Dr. med.

  University Hospital Basel, Division of Internal Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 19, 2023
• Study Start: December 21, 2022
• Primary Completion: February 2, 2024
• Study Completion: February 2, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Locations

CH (1)