Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-01-02 @ 12:20 PM
Study NCT ID:
NCT00330395
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2006-05-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Colombia', 'India', 'Mexico', 'Panama', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D002177', 'term': 'Candidiasis'}], 'ancestors': [{'id': 'D009181', 'term': 'Mycoses'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-20', 'studyFirstSubmitDate': '2006-05-24', 'studyFirstSubmitQcDate': '2006-05-24', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-05-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters of drug exposure'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability'}]}, 'conditionsModule': {'conditions': ['Candidiasis']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/policies-perspectives.html', 'type': 'CSR Synopsis'}], 'references': [{'pmid': '19075070', 'type': 'BACKGROUND', 'citation': 'Saez-Llorens X, Macias M, Maiya P, Pineros J, Jafri HS, Chatterjee A, Ruiz G, Raghavan J, Bradshaw SK, Kartsonis NA, Sun P, Strohmaier KM, Fallon M, Bi S, Stone JA, Chow JW. Pharmacokinetics and safety of caspofungin in neonates and infants less than 3 months of age. Antimicrob Agents Chemother. 2009 Mar;53(3):869-75. doi: 10.1128/AAC.00868-08. Epub 2008 Dec 15.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the amount of caspofungin found in the blood of neonate and infants \\<3 months of age following treatment with caspofungin at 25 mg/m2. Another purpose is to test the safety of caspofungin in treating neonates and infants with Candida infections (a certain type of fungal infection).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates and infants \\<3 months of age\n* Patient has a body weight greater than or equal to 500 grams\n* Patient has documented or highly suspected Candida infection\n\nExclusion Criteria:\n\n* Patient is greater than 3 months of age\n* Patient has a body weight of less than 500 grams\n* Patient does not meet certain laboratory testing criteria\n* Patient is hemodynamically unstable, exhibits hemodynamic compromise or is not expected to survive at least 5 days\n* Patient has documented HIV infection of any stage\n* Patient has a history of allergy, hypersensitivity, or serious reaction to caspofungin or another member of the echinocandin class'}, 'identificationModule': {'nctId': 'NCT00330395', 'briefTitle': 'Open, Pharmacokinetic Study of Caspofungin in Neonates and Infants (0991-058)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multicenter, Sequential-Panel, Open-Label, Noncomparative Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Caspofungin Acetate in Neonates and Infants Less Than 3 Months of Age.', 'orgStudyIdInfo': {'id': '0991-058'}, 'secondaryIdInfos': [{'id': 'MK0991-058'}, {'id': '2006_025'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'caspofungin acetate', 'type': 'DRUG', 'otherNames': ['MK0991'], 'description': 'Duration of Treatment 28 Days'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}