Thermal InjuryPhase 2/3Caspo-brûlésNCT00748345
Pharmacokinetics of Caspofungin in Burn Patients
A Phase 2/3 study testing Caspofungin (drug) in people with Thermal Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients. Additionally, burn patient population exhibits a wide inter- and intrapatient variation in drug handling. Several investigations carried out in burn patients treated with e.g. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thermal Injury
- What is being tested?
- Caspofungin (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Dec 2010
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18 - 60 years old
- burn surface : 20-60% total body surface area
- delay of injury time : 8-15 days
- lack of fungal infection
- delay of hospitalization : > 5 days
- written informed consent
- last biological picture in 24 hours before inclusion
Who cannot join
- survival inferior to 5 days
- surgical intervention planned in the next five days following inclusion
- moderate or severe hepatic impairment according to Child Plug B > 9
- pregnancy
- allergy to caspofungin or excipients (saccharose, mannitol and frozen acetic acid)
- patient already included in other study
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- concomitant administration of CYP450 inducers : rifampicin, efavirenz, phenobarbital, phenytoin, carbamazepine
- withdrawal of consent
- event (during the first 48 hours following administration) susceptible to modify pharmacokinetic parameters
- Investigator decision
- no social security insurance
Trial locations and contacts
1 site in 1 country.
About this study
Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients. Additionally, burn patient population exhibits a wide inter- and intrapatient variation in drug handling. Several investigations carried out in burn patients treated with e.g. fluconazole showed the requirement to increase daily dose in comparison with healthy volunteers. However, no pharmacokinetic data are available of caspofungin in the burn population. The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population.
Read the detailed description
The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.). Blood samples are drawn just before administration and 0.25, 0.5,1 1.5, 3, 6, 12, 24, 48, 72, 96 and 120 hours after administration. Caspofungin plasma concentrations are measured by liquid-chromatography spectrometry mass tandem.The primary end-points are :
- area under the curve of caspofungin plasma concentrations over 24 hours
- mean peak level and trough concentration (24 hours after dosing)
The secondary end-points are :
- mean total clearance
- mean distribution volume These parameters will be compared to those usually observed in non burn patients. The optimal dose in burn patients is the dose achieving an exposure similar to that in non burn patients.
- Conditions
- Thermal Injury
- Being tested
- Caspofungin (drug)
- Keywords
- Caspofungin,, burn patients,, pharmacokinetics,, optimal dose,, antifungal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caspofungin (drug)Drug
Also called pharmacokinetics of caspofungin in burn patients
pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Caspofungin (drug) Receives: Drug: Caspofungin (drug) |
What is being measured
The primary outcome is the main question the study is designed to answer.
area under the curve of caspofungin plasma concentrations over 24 hours mean peak level and trough concentration (24 hours after dosing)
Measured: 18 months
Secondary outcomes (2)
mean total clearance
Measured: 18 months
mean distribution volume
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startFeb 2009
- Primary completionFeb 2010
- Study completionDec 2010
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 Thermal InjuryStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Christophe Vinsonneau, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748345
- Sponsor's protocol ID
- P070601
- Acronym
- Caspo-brûlés
- Status last verified
- Mar 2026
- First submitted
- 31 Jul 2008
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jullien V, Blanchet B, Benyamina M, Tod M, Vinsonneau C. Pharmacokinetics of caspofungin in two patients with burn injuries. Antimicrob Agents Chemother. 2012 Aug;56(8):4550-1. doi: 10.1128/AAC.00039-12. Epub 2012 May 14. No abstract available.
PubMed 22585216
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Caspofungin in Burn Patients
- ClinicalTrials.gov ID
- NCT00748345
- Acronym / sponsor ID
- Caspo-brûlés / P070601
- Conditions
- Thermal Injury
- Keywords
- Caspofungin,, burn patients,, pharmacokinetics,, optimal dose,, antifungal treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Feb 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 8 Sep 2008 (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.
Drug pharmacokinetics of antimicrobial agents is significantly altered in the burn patients. Additionally, burn patient population exhibits a wide inter- and intrapatient variation in drug handling. Several investigations carried out in burn patients treated with e.g. fluconazole showed the requirement to increase daily dose in comparison with healthy volunteers. However, no pharmacokinetic data are available of caspofungin in the burn population. The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population.
Detailed description
The aim of this investigation is to investigate pharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.). Blood samples are drawn just before administration and 0.25, 0.5,1 1.5, 3, 6, 12, 24, 48, 72, 96 and 120 hours after administration. Caspofungin plasma concentrations are measured by liquid-chromatography spectrometry mass tandem.The primary end-points are :
- area under the curve of caspofungin plasma concentrations over 24 hours
- mean peak level and trough concentration (24 hours after dosing)
The secondary end-points are :
- mean total clearance
- mean distribution volume These parameters will be compared to those usually observed in non burn patients. The optimal dose in burn patients is the dose achieving an exposure similar to that in non burn patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Caspofungin (drug)Caspofungin (drug) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18 - 60 years old
- burn surface : 20-60% total body surface area
- delay of injury time : 8-15 days
- lack of fungal infection
- delay of hospitalization : > 5 days
Key exclusion criteria (11 listed)
- survival inferior to 5 days
- surgical intervention planned in the next five days following inclusion
- moderate or severe hepatic impairment according to Child Plug B > 9
- pregnancy
- allergy to caspofungin or excipients (saccharose, mannitol and frozen acetic acid)
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 |
|---|---|---|
| Caspofungin (drug)Also: pharmacokinetics of caspofungin in burn patientspharmacokinetics of caspofungin in burn patients after a single usual dose (70 mg i.v.), in order to determine the optimal dose in this population | Drug | 1 |
Primary outcome
area under the curve of caspofungin plasma concentrations over 24 hours mean peak level and trough concentration (24 hours after dosing)
Time frame: 18 months
2 secondary outcomes
mean total clearance
Time frame: 18 months
mean distribution volume
Time frame: 12 months
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 4 Mar 2026.
- Results publication: PubMed 22585216Jullien V, Blanchet B, Benyamina M, Tod M, Vinsonneau C. Pharmacokinetics of caspofungin in two patients with burn injuries. Antimicrob Agents Chemother. 2012 Aug;56(8):4550-1. doi: 10.1128/AAC.00039-12. Epub 2012 May 14. No abstract available.
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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.
Christophe Vinsonneau, MD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Caspofungin (drug) in people with Thermal Injury, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 7 inclusion and 11 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 4 Mar 2026. 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 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
area under the curve of caspofungin plasma concentrations over 24 hours mean peak level and trough concentration (24 hours after dosing) (time frame: 18 months). 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 NCT00748345, 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 4 Mar 2026.