ShockCaspoKinNCT02596984
Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients
A study testing Caspofungin in people with Shock, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
Trial summary
Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shock
- What is being tested?
- Caspofungin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesFrance
- Study dates
- 16 Mar 2015to 31 May 2018
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients (age > 18 y.o)
- Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician
- Requiring vasopressors
- Admission in one of the participating ICUs.
Who cannot join
- Pregnancy
- Lack of affiliation to the National Medical Insurance
- Previous inclusion in the study
- Inclusion in a concomitant study that may interact with the current study
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU de CLERMONT-FERRAND
Clermont-Ferrand, 63000
Hôpital Saint-Louis
Paris, 75010
CHU de SAINT-ETIENNE
Saint-Etienne, 42000
About this study
Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. Thus, studies performed so far show Caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. One of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. These results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed.
The primary objective of this study is to assess Caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.
- Conditions
- Shock
- Being tested
- Caspofungin
- Keywords
- Intensive Care Unit, Shock, Antifungal agent, Pharmacokinetics, Sepsis
- Medical subject headings
- Shock, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaspofunginDrug
Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician. Caspofungin will be administered according to the international recommendation
| Study group | Role | What they receive |
|---|---|---|
| caspofungin | Experimental | Caspofungin will be administered according to the international recommendation. Receives: Drug: Caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caspofungin pharmacokinetic : clearance (ml.min-1)
Measured: day 2 - day 3 - day 4
Caspofungin pharmacokinetic : volume of distribution (mL)
Measured: day 2 - day 3 - day 4
Secondary outcomes (2)
Caspofungin trough concentration
Measured: day 2 - day 3 - day 4
proportion of patients for whom the trough concentrations are lower than the MIC (Minimum Inhibitory Concentration) 90 of Candida ( 1mg / L)
Measured: day 2 - day 3 - day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2015 (estimated)
- Study start16 Mar 2015
- Primary completionMay 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShockStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Michael DARMON, MD PhD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02596984
- Sponsor's protocol ID
- 1308173
- Other IDs
- 140413A-41, 2014-000789-22, 2014
- Acronym
- CaspoKin
- Status last verified
- Jun 2019
- First submitted
- 3 Nov 2015
- Last updated
- 14 Jun 2019
- 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 14 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Pharmacokinetics of Caspofungin in ICU Patients
- ClinicalTrials.gov ID
- NCT02596984
- Acronym / sponsor ID
- CaspoKin / 1308173
- Conditions
- Shock
- Keywords
- Intensive Care Unit, Shock, Antifungal agent, Pharmacokinetics, Sepsis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 16 Mar 2015 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 4 Nov 2015 (estimated)
- 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.
Although the pharmacokinetics of Caspofungin has been studied in healthy subjects and patients, only a few studies have been performed in critically-ill patients. In these patients several factors, including sepsis, shock, increased distribution volume, hepatic dysfunction and hypoalbuminemia may result in dramatic changes in antibiotic concentrations and pharmacokinetics. Caspofungin pharmacokinetic data is scarce and are results mainly from case series or animal studies. Thus, studies performed so far show Caspofungin trough concentrations either decreased, similar to usual value in non-critically ill patients or increased. One of these studies suggested that body weight and hypoalbuminemia may be the main factors associated with Caspofungin pharmacokinetic variability. Pharmacokinetic parameters of caspofungin in pigs with hypovolemic shock suggested the peripheral volume of distribution of caspofungin and intercompartmental clearance to be higher than in healthy animals. These results are however preliminary and cannot be extrapolated suggesting further clinical studies in human to be needed.
The primary objective of this study is to assess Caspofungin trough concentrations and pharmacokinetics in critically-ill patients requiring vasopressors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| caspofungin | Experimental | Drug: CaspofunginCaspofungin will be administered according to the international recommendation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (age > 18 y.o)
- Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician
- Requiring vasopressors
- Admission in one of the participating ICUs.
Key exclusion criteria (4 listed)
- Pregnancy
- Lack of affiliation to the National Medical Insurance
- Previous inclusion in the study
- Inclusion in a concomitant study that may interact with the current study
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 |
|---|---|---|
| CaspofunginEither preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician. Caspofungin will be administered according to the international recommendation | Drug | caspofungin |
Primary outcome
Caspofungin pharmacokinetic : clearance (ml.min-1)
Time frame: day 2 - day 3 - day 4
Caspofungin pharmacokinetic : volume of distribution (mL)
Time frame: day 2 - day 3 - day 4
2 secondary outcomes
Caspofungin trough concentration
Time frame: day 2 - day 3 - day 4
proportion of patients for whom the trough concentrations are lower than the MIC (Minimum Inhibitory Concentration) 90 of Candida ( 1mg / L)
Time frame: day 2 - day 3 - day 4
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 14 Jun 2019.
Related trials for Shock
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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.
Michael DARMON, MD PhD principal investigator
CHU de SAINT-ETIENNE
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caspofungin in people with Shock, run by Centre Hospitalier Universitaire de Saint Etienne at 3 sites in France.
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 4 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 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. 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?
Caspofungin pharmacokinetic : clearance (ml.min-1) (time frame: day 2 - day 3 - day 4). The study lists 2 primary outcomes in all. 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 14 Jun 2019.