Septic ShockNCT03399032
Pharmacokinetics of Caspofungin
An observational study of Septic Shock and Fungal Infection, run by Medical University of Lublin at 1 site in Poland.
Trial summary
The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septic Shock, Fungal Infection, Critical Illness
- What is being tested?
- Caspofungin
- Type of treatment
- Injection or infusion
- How many people
- 33 participants
- Where
- 1 sitePoland
- Study dates
- 5 Feb 2018to 3 Sep 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 18 to 80 years
- All sexes
- Adult, Older adult
Study population: Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical patients will be included. Any site of infection will be treated in the manner.
Who may be able to join
- Patients who require ICU treatment due to severe sepsis age
- 18-80 years
- an eligible consent obtained from the patient or his/her attendant
Who cannot join
- allergy to caspofungin
- lack of consent to participate in the study
- age of patients below 18 or above 80 years
Trial locations and contacts
1 site in 1 country.
Poland1 site
II Department of Anesthesia and Intensive Care, Medical University of Lublin
Lublin, 20-081
About this study
Official title: Pharmacokinetics of Caspofungin in Critically Ill Patients
The objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.
Read the detailed description
This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: broad spectrum anti-bacterial antibiotics plus caspofungin (70 mg i.v. on the first day day, and 50 mg i.v. on the consecutive days, once daily.
Blood samples (3 mL) will be collected 2, 4, 8,12 and 24 hours after each dose of caspofungin for 3 consecutive days. The standard arterial canula will be used to obtain samples.
30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.
Serum caspofungin concentration will be measured with high performance liquid chromatography.
Each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.
- Conditions
- Septic Shock, Fungal Infection, Critical Illness
- Being tested
- Caspofungin
- Keywords
- caspofungin, pharmacokinetics
- Medical subject headings
- Shock, Septic, Mycoses, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaspofunginDrug
Also called blood collection
Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day
Blood samples (3 mL) will be collected 2, 4, 8, 12 and 24 hours after each dose of caspofungin for 3 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| Caspofungin | Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day Receives: Drug: Caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of caspofungin
Samples obtain from ICU patients 2, 4, 8 12 and 24hours after each dose of caspofungin for 3 days.
Measured: 72 hours for each patient from the tigecycline treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start5 Feb 2018
- Primary completion6 Aug 2018
- Study completion3 Sep 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 Septic ShockStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Borys, Medical University of Lublin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399032
- Sponsor's protocol ID
- KE-0254/330/2017
- Status last verified
- Nov 2023
- First submitted
- 7 Jan 2018
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Borsuk-De Moor A, Sysiak-Slawecka J, Rypulak E, Borys M, Piwowarczyk P, Raszewski G, Onichimowski D, Czuczwar M, Wiczling P. Nonstationary Pharmacokinetics of Caspofungin in ICU Patients. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00345-20. doi: 10.1128/AAC.00345-20. Print 2020 Aug 20.
PubMed 32601169
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Caspofungin in Critically Ill Patients
- ClinicalTrials.gov ID
- NCT03399032
- Acronym / sponsor ID
- KE-0254/330/2017
- Conditions
- Septic Shock, Fungal Infection, Critical Illness
- Keywords
- caspofungin, pharmacokinetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Study start
- 5 Feb 2018 (actual)
- Primary completion
- 6 Aug 2018 (actual)
- Study completion
- 3 Sep 2018 (actual)
- First posted
- 16 Jan 2018 (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 objective of this study is to describe the pharmacokinetics of standard doses of caspofungin in critically ill patients.
Detailed description
This is a prospective observational study performed on critically ill patients. Inclusion criteria are: severe sepsis on admission requiring broad-spectrum antibiotics. Both medical and surgical patients will be included. Any type of infections will be included (pulmonary, abdominal, urinary tract, etc.) Antibiotics regimen includes: broad spectrum anti-bacterial antibiotics plus caspofungin (70 mg i.v. on the first day day, and 50 mg i.v. on the consecutive days, once daily.
Blood samples (3 mL) will be collected 2, 4, 8,12 and 24 hours after each dose of caspofungin for 3 consecutive days. The standard arterial canula will be used to obtain samples.
30 minutes after each sample collection, blood will be centrifuged for 10 minutes at 3,000 rpms. Subsequently, supernatant will be collected and frozen.
Serum caspofungin concentration will be measured with high performance liquid chromatography.
Each patient's hemodynamics parameters will be recorded with the use of transpulmonary thermodilution technique (PICCO). Other therapies i.e.: ventilatory support, sedation, an antifungal agent will be given as required.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Caspofungin | – | Drug: CaspofunginEach patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to ICU due to severer sepsis recognition. Both medical and surgical patients will be included. Any site of infection will be treated in the manner.
Key inclusion criteria (3 listed)
- Patients who require ICU treatment due to severe sepsis age
- 18-80 years
- an eligible consent obtained from the patient or his/her attendant
Key exclusion criteria (3 listed)
- allergy to caspofungin
- lack of consent to participate in the study
- age of patients below 18 or above 80 years
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 |
|---|---|---|
| CaspofunginAlso: blood collectionEach patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day Blood samples (3 mL) will be collected 2, 4, 8, 12 and 24 hours after each dose of caspofungin for 3 consecutive days. | Drug | Caspofungin |
Primary outcome
Serum concentration of caspofungin
Time frame: 72 hours for each patient from the tigecycline treatment initiation
Samples obtain from ICU patients 2, 4, 8 12 and 24hours after each dose of caspofungin for 3 days.
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 24 Nov 2023.
- Derived from this study: PubMed 32601169Borsuk-De Moor A, Sysiak-Slawecka J, Rypulak E, Borys M, Piwowarczyk P, Raszewski G, Onichimowski D, Czuczwar M, Wiczling P. Nonstationary Pharmacokinetics of Caspofungin in ICU Patients. Antimicrob Agents Chemother. 2020 Aug 20;64(9):e00345-20. doi: 10.1128/AAC.00345-20. Print 2020 Aug 20.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Septic Shock and Fungal Infection, run by Medical University of Lublin at 1 site in Poland.
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 3 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 24 Nov 2023. 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 Poland. 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?
Serum concentration of caspofungin (time frame: 72 hours for each patient from the tigecycline treatment initiation). 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 NCT03399032, 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 24 Nov 2023.