Pharmacokinetics of Caspofungin in Burn Patients (NCT00748345) | Clinical Trial Compass
CompletedPhase 2/3
Pharmacokinetics of Caspofungin in Burn Patients
France2 participantsStarted 2009-02
Plain-language 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. 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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
area under the curve of caspofungin plasma concentrations over 24 hours mean peak level and trough concentration (24 hours after dosing)