Critical IllnessNCT03798600
Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization
An observational study of Critical Illness and Infection, run by Careggi Hospital.
Trial summary
PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology. Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Critical Illness, Infection
- What is being tested?
- Caspofungin
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2016to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study.
Who may be able to join
- Adult ICU patients (>18 yrs)
- Severe sepsis or septic shock
- Caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).
Who cannot join
- Concomitant ciclosporin or rifampicin therapy.
- Pregnancy
- Continuous renal replacement therapy
- Severe Liver failure (Child Pugh score > 6)
About this study
PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology.
Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.
Read the detailed description
Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients.
- Conditions
- Critical Illness, Infection
- Being tested
- Caspofungin
- Keywords
- Caspofungin, pharmacokinetic, pharmacodynamic
- Medical subject headings
- Critical Illness, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaspofunginDrug
In accordance with routine clinical practice, Caspofungin will be given at the loading dose of 70 mg followed by 50 mg daily (for people < 80 kg body weight). No dose reduction will be performed in Child-Pugh score A or B. Duration of therapy will be performed in accordance with ESCMID guidelines and clinical conditions.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients | 20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study.
Inclusion Criteria:
Adult ICU patients (>18 yrs) with severe sepsis or septic shock undergoing caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).
Exclusion criteria:
Concomitant ciclosporin or rifampicin therapy. Pregnancy Continuous renal replacement therapy Severe Liver failure (Child Pugh score > 6) Receives: Drug: Caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.
Measured: first 24 hours after loading dose
Secondary outcomes (13)
Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
Measured: first 24 hours after loading dose
Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
The Cmax/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
Measured: at day 4 after loading dose
Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
Measured: first 24 hours after loading dose
Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
The AUC/MIC ratio, will be calculated and compared with that reported in the literature to obtain the infection eradication.
Measured: at day 4 after loading dose
Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
Measured: first 24 hours after loading dose
Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin maximum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
Measured: at day 4 after loading dose
Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
Measured: first 24 hours after loading dose
Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin minimum serum concentrations will be described and compared with those reported in the literature for healthy volunteers.
Measured: at day 4 after loading dose
Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers.
Measured: first 24 hours after loading dose
Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin volume distribution will be described and compared with those reported in the literature for healthy volunteers.
Measured: at day 4 after loading dose
Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers.
Measured: first 24 hours after loading dose
Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin elimination half life will be described and compared with those reported in the literature for healthy volunteers.
Measured: at day 4 after loading dose
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.
Measured: at day 4 after loading dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2019
- Study start1 Jan 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Careggi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gianluca Villa, Careggi Hospital
- Investigators
- Gianluca Villa, MD, Principal investigator, Azienda Careggi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03798600
- Sponsor's protocol ID
- CEAVC, 32366/2015; OSS.15.114
- Status last verified
- Jan 2019
- First submitted
- 4 Jan 2019
- Last updated
- 17 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adembri C, Villa G, Rosi E, Tofani L, Fallani S, De Gaudio AR, Novelli A. Caspofungin PK in critically ill patients after the first and fourth doses: suggestions for therapeutic drug monitoring? J Chemother. 2020 May;32(3):124-131. doi: 10.1080/1120009X.2020.1737783. Epub 2020 Mar 23.
PubMed 32202224
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics/Pharmacodynamics (PK/PD) of Caspofungin in Intensive Care Unit (ICU) Patients. An Open Observational Study for Antifungal Treatment's Optimization
- ClinicalTrials.gov ID
- NCT03798600
- Acronym / sponsor ID
- CEAVC, 32366/2015; OSS.15.114
- Conditions
- Critical Illness, Infection
- Keywords
- Caspofungin, pharmacokinetic, pharmacodynamic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Careggi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2016 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 10 Jan 2019 (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.
PK of Caspofungin in ICU septic patients might be changed as compared to healthy volunteers due to sepsis-related pathophysiology.
Sub-optimal plasma and tissue concentrations might be achieved in these patients when drugs are administered at the same dosage/regimen suggested for healthy volunteers.
Detailed description
Open non randomized, non controlled single center study on the pharmacokinetics of caspofungin in 20 consecutive ICU patients with severe sepsis or septic shock, requiring caspofungin therapy and PK-PD evaluation for the optimization of caspofungin therapy. The aim of this study is to describe the Caspofungin PK-PD alterations in a cohort of critically ill septic patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients | – | Drug: Caspofungin20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study. Inclusion Criteria: Adult ICU patients (>18 yrs) with severe sepsis or septic shock undergoing caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy). Exclusion criteria: Concomitant ciclosporin or rifampicin therapy. Pregnancy Continuous renal replacement therapy Severe Liver failure (Child Pugh score > 6) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 20 patients consecutively admitted in the ICU with severe sepsis or septic shock requiring caspofungin therapy will be considered for this observational study.
Key inclusion criteria (3 listed)
- Adult ICU patients (>18 yrs)
- Severe sepsis or septic shock
- Caspofungin therapy based on clinical judgement (empiric therapy) or microbiological result (targeted therapy).
Key exclusion criteria (4 listed)
- Concomitant ciclosporin or rifampicin therapy.
- Pregnancy
- Continuous renal replacement therapy
- Severe Liver failure (Child Pugh score > 6)
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 |
|---|---|---|
| CaspofunginIn accordance with routine clinical practice, Caspofungin will be given at the loading dose of 70 mg followed by 50 mg daily (for people < 80 kg body weight). No dose reduction will be performed in Child-Pugh score A or B. Duration of therapy will be performed in accordance with ESCMID guidelines and clinical conditions. | Drug | Critically ill patients |
Primary outcome
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: first 24 hours after loading dose
The caspofungin AUC will be described and compared with that reported in the literature for healthy volunteers.
13 secondary outcomes
Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
Time frame: first 24 hours after loading dose
Alterations of Cmax/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
Time frame: at day 4 after loading dose
Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
Time frame: first 24 hours after loading dose
Alterations of AUC/MIC target - which guarantees the maximal exposure of Candida spp to caspofungin
Time frame: at day 4 after loading dose
Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: first 24 hours after loading dose
Alterations of Caspofungin maximum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: at day 4 after loading dose
Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: first 24 hours after loading dose
Alterations of Caspofungin minimum serum concentrations in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: at day 4 after loading dose
Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: first 24 hours after loading dose
Alterations of Caspofungin volume distribution in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: at day 4 after loading dose
Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: first 24 hours after loading dose
Alterations of Caspofungin elimination half life in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: at day 4 after loading dose
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU).
Time frame: at day 4 after loading dose
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 17 Jan 2019.
- Derived from this study: PubMed 32202224Adembri C, Villa G, Rosi E, Tofani L, Fallani S, De Gaudio AR, Novelli A. Caspofungin PK in critically ill patients after the first and fourth doses: suggestions for therapeutic drug monitoring? J Chemother. 2020 May;32(3):124-131. doi: 10.1080/1120009X.2020.1737783. Epub 2020 Mar 23.
- Individual participant dataSharing planned: No
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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.
Gianluca Villa, MD principal investigator
Azienda Careggi
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Infection, run by Careggi Hospital.
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 3 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 17 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Alterations of Caspofungin Area Under the curve (AUC) in septic patients admitted to the Intensive Care Unit (ICU). (time frame: first 24 hours after loading dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03798600, which also lists 1 linked publication.
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 17 Jan 2019.