Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-05 @ 1:39 PM
Study NCT ID:
NCT00679835
Status:
COMPLETED
Last Update Posted:
2019-11-13
First Post:
2008-05-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017576', 'term': 'Daptomycin'}], 'ancestors': [{'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2008-11-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-11', 'studyFirstSubmitDate': '2008-05-15', 'studyFirstSubmitQcDate': '2008-05-16', 'lastUpdatePostDateStruct': {'date': '2019-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmocokinetics of daptomycin', 'timeFrame': 'From pre-dose to 24 hours post-dose'}], 'secondaryOutcomes': [{'measure': 'Safety of daptomycin', 'timeFrame': 'Up to 9 days after dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gram Positive Infection', 'Concurrent Antibiotic Treatment']}, 'referencesModule': {'references': [{'pmid': '21317681', 'type': 'RESULT', 'citation': 'Abdel-Rahman SM, Chandorkar G, Akins RL, Bradley JS, Jacobs RF, Donovan J, Benziger DP. Single-dose pharmacokinetics and tolerability of daptomycin 8 to 10 mg/kg in children aged 2 to 6 years with suspected or proved Gram-positive infections. Pediatr Infect Dis J. 2011 Aug;30(8):712-4. doi: 10.1097/INF.0b013e31820fc8e1.'}]}, 'descriptionModule': {'briefSummary': 'This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 2 to 6 years who have infections that are caused by a specific group of bacteria (called Gram-positive bacteria).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written parental (or appropriate legal representative) informed consent prior to any study-related procedure not part of normal medical care;\n* Male or female between the ages of 2 and 6 years old, inclusive;\n* Able to comply with the protocol for the duration of the study;\n* Clinically stable with no evidence of hemodynamic instability (defined as a requirement for pharmacological intervention to manage blood pressure) in the 72 hour window prior to enrollment, and no history or evidence of renal or hepatic compromise;\n* Suspected or diagnosed Gram-positive infection for which the subject is receiving standard antibiotic therapy;\n* A calculated creatinine clearance rate (CLcr) ≥ 80 ml/min/1.73m2 as determined by the Schwartz equation at baseline;\n* Creatine phosphokinase (CPK) levels less than 2X ULN (upper limit of normal) at baseline.\n* Presence of two patent intravenous lines (or comparable means of venous access) prior to dosing on Study Day 1.\n\nExclusion Criteria:\n\n* Investigational drug use (including daptomycin) or participation in any experimental procedure in the 30 days preceding study entry;\n* Known allergy/ hypersensitivity to daptomycin;\n* History of clinically significant cardiovascular, renal, hepatic, pulmonary (well-controlled asthma is acceptable), gastrointestinal, endocrine, hematologic, autoimmune disease or primary immune deficiency;\n* Pneumonia as sole Gram-positive infection being treated with standard antibiotics;\n* Subjects with clinically significant abnormal laboratory test results \\[including electrocardiograms (ECGs)\\], as determined by Investigator;\n* Administration of rifampin within 7 days of study drug administration;\n* Body mass index (BMI) that is outside of the 5th to 95th percentile;\n* Subjects in whom collection of the required blood volume would put them at risk of hemodynamic disturbance (at the discretion of Investigator);\n* History of or current clinically significant (at the discretion of the Investigator) muscular disease, nervous system or seizure disorder;\n* Administration of intramuscular injection between baseline and study drug administration or expected intramuscular injection within 24 hours following dosing;\n* Expected surgical procedure(s) within 24 hours prior to and following dosing;\n* Unexplained muscular weakness, history of peripheral neuropathy, Guillian-Barre or spinal cord injury;\n* History of or current rhabdomyolysis.'}, 'identificationModule': {'nctId': 'NCT00679835', 'briefTitle': 'PK and Safety Evaluation of Daptomycin in Children Ages 2-6 With Proven or Suspected Gram-positive Infections', 'organization': {'class': 'INDUSTRY', 'fullName': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)'}, 'officialTitle': 'An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged Two to Six Years Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Gram-positive Infection', 'orgStudyIdInfo': {'id': '3009-023'}, 'secondaryIdInfos': [{'id': 'DAP-PEDS-07-02', 'type': 'OTHER', 'domain': 'Cubist Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': '8 mg/kg over a one hour infusion', 'interventionNames': ['Drug: daptomycin']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': '10mg/kg over a one or two hour infusion', 'interventionNames': ['Drug: daptomycin']}], 'interventions': [{'name': 'daptomycin', 'type': 'DRUG', 'otherNames': ['Cubicin'], 'description': 'i.v. daptomycin given at 8 mg/kg or 10 mg/kg by a one or two hour infusion.', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '64108', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Children's Mercy Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}