Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-27 @ 11:55 PM
Study NCT ID:
NCT04961593
Status:
RECRUITING
Last Update Posted:
2025-02-20
First Post:
2021-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK/PD of Caspofungin in Children Severe Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009181', 'term': 'Mycoses'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077336', 'term': 'Caspofungin'}], 'ancestors': [{'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D054714', 'term': 'Echinocandins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) Pharmacokinetic Parameter', 'timeFrame': 'Day 1-5', 'description': 'Time to reach the maximum plasma concentration (Tmax) after administrations of a single dose and multiple doses of the study drug'}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Concentration Pharmacokinetic Parameter', 'timeFrame': 'Day 1-5', 'description': 'Maximum observed plasma concentration (Cmax) is the peak plasma concentration after administrations of a single dose and multiple doses of the study drug'}, {'measure': 'AUC(0-inf): Area Under the Plasma Concentration-time Curve From Time 0 to Infinity Pharmacokinetic Parameter', 'timeFrame': 'Day1-5', 'description': 'Area under the plasma concentration-time curve from time 0 to infinity after administration of a single dose of the study drug.'}, {'measure': 'AUC(0-24): Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours Pharmacokinetic Parameter', 'timeFrame': 'Day1-5', 'description': 'Area under the curve from 0 to 24 hours after administrations of a single dose and multiple doses of the study drug.'}, {'measure': 'Terminal Phase Elimination Half-life (T1/2) Pharmacokinetic Parameter', 'timeFrame': 'Day1-5', 'description': 'Time required for half of the drug to be eliminated from the plasma after administration of a single dose of the study drug.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics', 'Infection, Fungal']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 ageļ¼25 mg per square metre is also recommended.\n\nWhether 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.\n\nThe 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.\n\nBlood sampling time points of caspofungin are listed as follow:\n\nBefore administration (0 min); 1 h, 2 h, 4 h, 8 h , 12 h and 24 h after administration.\n\nThe concentration of caspofungin in whole blood will be analyzed at Huashan Hospital of Fudan University.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children receiving caspofungin in pediatric intensive care unit including but not limited to children with liver insufficiency, hypoproteinemia, ECMO treatment, CRRT treatment or sepsis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children receiving caspofungin in pediatric intensive care unit\n\nExclusion Criteria:\n\n* No Informed Consent signed Participate in other clinical trials'}, 'identificationModule': {'nctId': 'NCT04961593', 'briefTitle': 'PK/PD of Caspofungin in Children Severe Infection', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospital of Fudan University"}, 'officialTitle': 'Pharmacokinetics and Pharmacodynamics of Caspofungin in Children Severe Infection', 'orgStudyIdInfo': {'id': 'fdpicu-24'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment group', 'description': 'Children treated with caspofungin in the pediatric intensive care unit', 'interventionNames': ['Drug: Caspofungin']}], 'interventions': [{'name': 'Caspofungin', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Guoping Lu, PhD', 'role': 'CONTACT', 'email': '13788904150@163.com', 'phone': '18017590817'}], 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'zip': '201102', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'facility': "Children's Hospital of Fudan University", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yixue Wang, doctor', 'role': 'CONTACT', 'email': 'yixuewang08@aliyun.com', 'phone': '8613524669352'}], 'overallOfficials': [{'name': 'Guoping Lu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospital of Fudan University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospital of Fudan University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}