Febrile Neutropenia (FN)NCT05689450
Probability of Optimal Target Attainment of Amikacin in Patients With Febrile Neutropenia During Treatment for a Hematological Disorder
An observational study of Febrile Neutropenia (FN), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Febrile Neutropenia (FN)
- What is being tested?
- Data collection: Amikacin concentration
- Type of treatment
- Injection or infusion
- How many people
- 92 participants
- Where
- 1 siteSwitzerland
- Study dates
- 21 Dec 2022to 2 Feb 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- Previous enrolment into the current study
- Outpatients
- Patients undergoing hemodialysis
- Women who are pregnant (special pharmacokinetic)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel, Division of Internal Medicine
Basel, 4031
About this study
Official title: Probability of Optimal Target Attainment of Amikacin in Patients With Febrile Neutropenia During Treatment for a Hematological Disorder: a Prospective, Single-centre Study and PKPD-analysis
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).
Read the detailed description
Amikacin is an aminoglycoside (AG) that exerts a rapid bactericidal effect against many Gram-negative pathogens. Its pharmacological effect depends on the peak concentration achieved. However, a common side effect of AG is dose-dependent acute kidney injury (AKI), especially when administered over several days due to an accumulation of the drug in the proximal renal tubular cells. In patients in advanced stage of a hematological disease, low body weight influences amikacin pharmacokinetics and pharmacodynamics (PKPD) and increases its clearance. However, there is little known about amikacin PKPD in patients with febrile neutropenia (FN). Whereas the therapeutic efficacy is associated with the peak concentration of AG, toxicity of AG depends on the area under the curve (AUC) or trough level of the drug. When using the AUC to predict renal toxicity, an AUC between 200 and 300 mg/L * h of amikacin has been proposed as a potential threshold for renal toxicity. At the University Hospital Basel (USB), amikacin is administered intravenously (iv) as once daily infusion combined with cefepime or piperacillin/tazobactam immediately after the occurrence of a fever spike in patients with FN. After the iv administration of amikacin, peak concentration is achieved after 30-60 min. The in-house guidelines recommend the administration of lower amikacin dosages compared to other published studies (15 mg/kg body weight vs. 20 mg/kg or up to 30 mg/kg). It remains unclear if adequate peak concentrations are achieved in patients with FN, when lower amikacin doses are administered. The aim of this study is to investigate the probability of optimal pharmacological target attainment (Cmax ≥60 mg/L) during amikacin treatment among patients with FN treated for hematological disorder in order to evaluate the in-house amikacin dosage recommendations. The current project includes the sampling of biological material during hospital admission and the collection of health-related personal data.
- Conditions
- Febrile Neutropenia (FN)
- Being tested
- Data collection: Amikacin concentration
- 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
- Medical subject headings
- Febrile Neutropenia, Hematologic Diseases, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collection: Amikacin concentrationOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Percentage of patients achieving the threshold of potential renal toxicity defined as AUC >200 mg/L and AUC >300 mg/L* h respectively during amikacin treatment
Measured: Up to 3 days after the beginning of amikacin infusion
Percentage of patients achieving a calculated Cmin <4 mg/L in blood
Percentage of patients achieving a calculated Cmin <4 mg/L in blood during amikacin treatment
Measured: Up to 3 days after the beginning of amikacin infusion
Incidence of Acute kidney injury (AKI)
Incidence of AKI
Measured: Within 7 days after application of amikacin
Percentage of patients with optimal pharmacological target attainment
Percentage of patients with optimal pharmacological target attainment using a Cmax/minimal inhibitory concentration (MIC) ≥8 in patients with an identified causative pathogen
Measured: 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
Time interval between the detection of the first fever spike and the administration of amikacin
Measured: One time assessment at baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start21 Dec 2022
- Primary completion2 Feb 2024
- Study completion2 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Febrile Neutropenia (FN)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Osthoff, PD Dr. med., Principal investigator, University Hospital Basel, Division of Internal Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05689450
- Sponsor's protocol ID
- 2022-01218; am23Osthoff
- Status last verified
- Feb 2024
- First submitted
- 4 Jan 2023
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probability of Optimal Target Attainment of Amikacin in Patients With Febrile Neutropenia During Treatment for a Hematological Disorder: a Prospective, Single-centre Study and PKPD-analysis
- ClinicalTrials.gov ID
- NCT05689450
- Acronym / sponsor ID
- 2022-01218; am23Osthoff
- 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)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 2 Feb 2024 (actual)
- Study completion
- 2 Feb 2024 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Amikacin is an aminoglycoside (AG) that exerts a rapid bactericidal effect against many Gram-negative pathogens. Its pharmacological effect depends on the peak concentration achieved. However, a common side effect of AG is dose-dependent acute kidney injury (AKI), especially when administered over several days due to an accumulation of the drug in the proximal renal tubular cells. In patients in advanced stage of a hematological disease, low body weight influences amikacin pharmacokinetics and pharmacodynamics (PKPD) and increases its clearance. However, there is little known about amikacin PKPD in patients with febrile neutropenia (FN). Whereas the therapeutic efficacy is associated with the peak concentration of AG, toxicity of AG depends on the area under the curve (AUC) or trough level of the drug. When using the AUC to predict renal toxicity, an AUC between 200 and 300 mg/L * h of amikacin has been proposed as a potential threshold for renal toxicity. At the University Hospital Basel (USB), amikacin is administered intravenously (iv) as once daily infusion combined with cefepime or piperacillin/tazobactam immediately after the occurrence of a fever spike in patients with FN. After the iv administration of amikacin, peak concentration is achieved after 30-60 min. The in-house guidelines recommend the administration of lower amikacin dosages compared to other published studies (15 mg/kg body weight vs. 20 mg/kg or up to 30 mg/kg). It remains unclear if adequate peak concentrations are achieved in patients with FN, when lower amikacin doses are administered. The aim of this study is to investigate the probability of optimal pharmacological target attainment (Cmax ≥60 mg/L) during amikacin treatment among patients with FN treated for hematological disorder in order to evaluate the in-house amikacin dosage recommendations. The current project includes the sampling of biological material during hospital admission and the collection of health-related personal data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- Previous enrolment into the current study
- Outpatients
- Patients undergoing hemodialysis
- Women who are pregnant (special pharmacokinetic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collection: Amikacin concentrationBlood 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. | Other | – |
Primary outcome
Change in pharmacological target attainment (Cmax ≥60 mg/L) in blood during amikacin treatment
Time frame: 60 minutes (+/-30 minutes) and 8 hours (+/-1 hour) after the beginning of amikacin infusion on day 1, day 2 and day 3
Percentage of patients with optimal pharmacological target attainment (Cmax ≥60 mg/L) in blood during amikacin treatment
5 secondary outcomes
AUC >200 mg/L and AUC >300 mg/L* h during amikacin treatment
Time frame: Up to 3 days after the beginning of amikacin infusion
Percentage of patients achieving a calculated Cmin <4 mg/L in blood
Time frame: Up to 3 days after the beginning of amikacin infusion
Incidence of Acute kidney injury (AKI)
Time frame: Within 7 days after application of amikacin
Percentage of patients with optimal pharmacological target attainment
Time frame: 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
Time frame: One time assessment at baseline (Day 1)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
Related trials for Febrile Neutropenia (FN)
Not yet recruiting
Diagnostic Accuracy, Clinical Utility and Implementation of Point-of-Care Absolute Neutrophil Count in Suspected Neutropenic Fever (DUCATIS) - Diagnostic Accuracy (S1)
Suspected Neutropenic Fever, Confirmed Neutropenic Fever
Recruiting
Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients
Bloodstream Infection, Gram Negative Infections
Enrolling by invitationObservational study
Study on the Efficacy and Safety of Different Doses of PEG-rhG-CSF for Primary Prevention of Febrile Neutropenia
Malignant Tumor
Not yet recruitingObservational study
Correlation Between ANC and Bone Pain in Breast Cancer Patients Receiving Long-Acting G-CSF
Breast Cancer, Chemotherapy-Induced Neutropenia
RecruitingPhase 2
Phase II Study of QLC2519 in Pediatric Solid Tumor Participants
Pediatric Malignant Solid Tumor, Febrile Neutropenia (FN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Osthoff, PD Dr. med. principal investigator
University Hospital Basel, Division of Internal Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Febrile Neutropenia (FN), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pharmacological target attainment (Cmax ≥60 mg/L) in blood during amikacin treatment (time frame: 60 minutes (+/-30 minutes) and 8 hours (+/-1 hour) after the beginning of amikacin infusion on day 1, day 2 and day 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.