Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT03960905
Status:
UNKNOWN
Last Update Posted:
2019-05-23
First Post:
2019-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002494', 'term': 'Central Nervous System Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077723', 'term': 'Cefepime'}, {'id': 'D002442', 'term': 'Ceftazidime'}, {'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002509', 'term': 'Cephaloridine'}, {'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'plasma and hemocyte'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-05-22', 'studyFirstSubmitDate': '2019-04-27', 'studyFirstSubmitQcDate': '2019-05-22', 'lastUpdatePostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maximum concentration (Cmax)', 'timeFrame': 'up to 4 weeks', 'description': 'Cmax is a term used in pharmacokinetics refers to the maximum (or peak) serum concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administrated and before the administration of a second dose.'}], 'secondaryOutcomes': [{'measure': 'time to achieve maximum concentration (Tmax)', 'timeFrame': 'up to 4 weeks', 'description': 'Tmax is the term used in pharmacokinetics to describe the time at which the Cmax is observed.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Central Nervous System Infection']}, 'descriptionModule': {'briefSummary': 'The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.', 'detailedDescription': 'The investigators aim to study the population pharmacokinetics of children receiving the anti-infective drugs for treatment of infectious disease in central nervous system.In this study, the investigators will detect drug concentration in plasma by using residual blood samples of blood gas analysis and other clinical tests and employ computers for constructing population pharmacokinetic models.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '29 Days', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Children with infections of center nurous system therapies.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children (29 days-18 years old) with anti-infective therapy against infectious disease in central nervous system.\n* Clinical symptoms: acute onset, fever (axillary temperature 38 ℃ or higher), headache, altered level of consciousness, vomiting, irritability, sleepiness, low muscle tone, seizures, before the fontanelle full or uplift, positive meningeal stimulation;\n* Aboratory examination: CSF appearance change, CSF routine WBC \\>100 per ml, CSF routine WBC 10-100 per ml, glucose \\<40mg/dl, protein \\>100mg/dl), positive detection of etiology (bacterial culture, antigen detection, gram staining).\n\nExclusion Criteria:\n\n* autoimmune encephalitis;\n* central nervous system infection complicated with tumor;\n* allergic to carbapenems or glycopeptide antibiotics;\n* other cases not suitable for enrollment (small sample size, incomplete clinical data, etc.).'}, 'identificationModule': {'nctId': 'NCT03960905', 'briefTitle': 'A Study the Population Pharmacokinetics of Children of Infectious Disease in Central Nervous System', 'organization': {'class': 'OTHER', 'fullName': 'Shandong University'}, 'officialTitle': 'A Study the Population Pharmacokinetics of Children Receiving the Anti-infective Drugs for Treatment of Infectious Disease in Central Nervous System', 'orgStudyIdInfo': {'id': '2019-CNSI-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Children with the usage of anti-infective drugs', 'description': 'in conformity with the clinical practice', 'interventionNames': ['Other: Children with the usage of anti-infective drugs']}], 'interventions': [{'name': 'Children with the usage of anti-infective drugs', 'type': 'OTHER', 'otherNames': ['Cefepime (Maxipime®)', 'ceftazidime', 'meropenem (Mepem®)'], 'description': 'According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.', 'armGroupLabels': ['Children with the usage of anti-infective drugs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100045', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Liu Gang, Ph.D.', 'role': 'CONTACT', 'email': 'liugang@bch.com.cn', 'phone': '010-59617011'}], 'facility': "Department of Infectious Diseases, Beijing Children's Hospital, Capital Medical University, National Center for Children's Health", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Zhao Wei, Ph.D', 'role': 'CONTACT', 'email': 'zhao4wei2@hotmail.com', 'phone': '053188383308'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wei Zhao', 'class': 'OTHER'}, 'collaborators': [{'name': "Beijing Children's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor; Head of department of clinical pharmacy and pharmacology', 'investigatorFullName': 'Wei Zhao', 'investigatorAffiliation': 'Shandong University'}}}}