PharmacokineticsNCT04961593
PK/PD of Caspofungin in Children Severe Infection
An observational study of Pharmacokinetics and Infection, Fungal, run by Children's Hospital of Fudan University at 2 sites in China.
Trial summary
Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. Read more about this study
- Who is it for?
- Ages 3 months to 18 years
- Conditions the study is for
- Pharmacokinetics, Infection, Fungal
- What is being tested?
- Caspofungin
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2022to 1 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children receiving caspofungin in pediatric intensive care unit including but not limited to children with liver insufficiency, hypoproteinemia, ECMO treatment, CRRT treatment or sepsis.
Who may be able to join
- Children receiving caspofungin in pediatric intensive care unit
Who cannot join
- No Informed Consent signed Participate in other clinical trials
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Guoping Lu, PhD, 18017590817, 13788904150@163.com
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
About this study
Official title: Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection
Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. There is little metabolism of caspofungin through the kidney and continuous renal replacement therapy and renal function have little influence on the pharmacokinetics of caspofungin. The study aim to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.
Read the detailed description
The current international recommended dose of caspofungin is 70 mg per square metre for load for children who is older than three months of age, followed by 50 mg per square metre for maintenance. For newborns and infants younger than 3 months of age，25 mg per square metre is also recommended.
Whether such a recommended dose can achieve an ideal PK/PD target in children with liver insufficiency, hypoproteinemia, ECMO treatment, or severe infection is still lacking in sufficient clinical data.
The objective of this study is to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.
Blood sampling time points of caspofungin are listed as follow:
Before administration (0 min); 1 h, 2 h, 4 h, 8 h , 12 h and 24 h after administration.
The concentration of caspofungin in whole blood will be analyzed at Huashan Hospital of Fudan University.
- Conditions
- Pharmacokinetics, Infection, Fungal
- Being tested
- Caspofungin
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaspofunginDrug
For children 3 months of age, the recommended dose is 70 mg/m2 for load and then 50 mg/m2 for maintenance, intravenous injection, once daily up to 5 days.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Children treated with caspofungin in the pediatric intensive care unit Receives: Drug: Caspofungin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
Measured: Day 1-5
Secondary outcomes (4)
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter
Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug
Measured: Day 1-5
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter
Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.
Measured: Day1-5
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter
Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.
Measured: Day1-5
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter
Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.
Measured: Day1-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start1 Oct 2022
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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 PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoping Lu, doctor, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961593
- Sponsor's protocol ID
- fdpicu-24
- Status last verified
- Feb 2026
- First submitted
- 5 Jul 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu N, Shi Y, Ju G, Liu X, Yan G, Zheng Y, Hou S, Xiang X, Lu G, Ouyang D, Zhu X, Wang Y. Population pharmacokinetics of caspofungin in critically ill Chinese children: a prospective observational study. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0127725. doi: 10.1128/aac.01277-25. Epub 2025 Dec 30.
PubMed 41468548
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection
- ClinicalTrials.gov ID
- NCT04961593
- Acronym / sponsor ID
- fdpicu-24
- Conditions
- Pharmacokinetics, Infection, Fungal
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jul 2021 (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.
Caspofungin is an anti-fungal drug mainly metabolized by the liver. The pathophysiological status of children with severe infection will affect the metabolism of caspofungin in the body especially in the case of liver dysfunction. There is little metabolism of caspofungin through the kidney and continuous renal replacement therapy and renal function have little influence on the pharmacokinetics of caspofungin. The study aim to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.
Detailed description
The current international recommended dose of caspofungin is 70 mg per square metre for load for children who is older than three months of age, followed by 50 mg per square metre for maintenance. For newborns and infants younger than 3 months of age，25 mg per square metre is also recommended.
Whether such a recommended dose can achieve an ideal PK/PD target in children with liver insufficiency, hypoproteinemia, ECMO treatment, or severe infection is still lacking in sufficient clinical data.
The objective of this study is to investigate PK/PD of caspofungin in children with specific pathophysiological conditions, such as liver insufficiency, hypoproteinemia, ECMO treatment, or sepsis.
Blood sampling time points of caspofungin are listed as follow:
Before administration (0 min); 1 h, 2 h, 4 h, 8 h , 12 h and 24 h after administration.
The concentration of caspofungin in whole blood will be analyzed at Huashan Hospital of Fudan University.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: CaspofunginChildren treated with caspofungin in the pediatric intensive care unit |
Who may qualify
- Ages
- 3 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children receiving caspofungin in pediatric intensive care unit including but not limited to children with liver insufficiency, hypoproteinemia, ECMO treatment, CRRT treatment or sepsis.
Key inclusion criteria (1 listed)
- Children receiving caspofungin in pediatric intensive care unit
Key exclusion criteria (1 listed)
- No Informed Consent signed Participate in other clinical trials
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 |
|---|---|---|
| CaspofunginFor children 3 months of age, the recommended dose is 70 mg/m2 for load and then 50 mg/m2 for maintenance, intravenous injection, once daily up to 5 days. | Drug | Treatment group |
Primary outcome
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter
Time frame: Day 1-5
Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug
4 secondary outcomes
Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter
Time frame: Day 1-5
AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter
Time frame: Day1-5
AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter
Time frame: Day1-5
Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter
Time frame: Day1-5
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 41468548Xu N, Shi Y, Ju G, Liu X, Yan G, Zheng Y, Hou S, Xiang X, Lu G, Ouyang D, Zhu X, Wang Y. Population pharmacokinetics of caspofungin in critically ill Chinese children: a prospective observational study. Antimicrob Agents Chemother. 2026 Feb 4;70(2):e0127725. doi: 10.1128/aac.01277-25. Epub 2025 Dec 30.
- 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.
Guoping Lu, doctor principal investigator
Children's Hospital of Fudan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Infection, Fungal, run by Children's Hospital of Fudan University at 2 sites in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yixue Wang, doctor (8613524669352, yixuewang08@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter (time frame: Day 1-5). 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 NCT04961593, 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 Feb 2026.