Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT01344512
Status:
COMPLETED
Last Update Posted:
2015-03-18
First Post:
2011-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Population Pharmacokinetics of Anti-infectious Drugs in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002442', 'term': 'Ceftazidime'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D065819', 'term': 'Voriconazole'}], 'ancestors': [{'id': 'D002509', 'term': 'Cephaloridine'}, {'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': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 214}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-17', 'studyFirstSubmitDate': '2011-04-27', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2015-03-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Population pharmacokinetic parameters and factors explaining variability', 'timeFrame': 'Between 2 and 4 days after the begining of the treatment', 'description': 'Population Pharmacokinetic Parameters and variability factors (Sex, Age, Genetic factors...) for ceftazidime, ciprofloxacin and voriconazole.\n\nAccording to the age of participants, 2 or 3 bloods sampling will be take between 2 and 4 days after the beginning of the treatment.'}], 'secondaryOutcomes': [{'measure': 'Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...)', 'timeFrame': 'Between 2 and 4 days after the beginning of the treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetic', 'Population', 'Children', 'Ceftazidime', 'Ciprofloxacin', 'Voriconazole', 'Pediatric'], 'conditions': ['Pediatrics', 'Ceftazidime', 'Ciprofloxacin', 'Voriconazole']}, 'referencesModule': {'references': [{'pmid': '32457995', 'type': 'DERIVED', 'citation': 'Bui S, Facchin A, Ha P, Bouchet S, Leroux S, Nacka F, Fayon M, Jacqz-Aigrain E. Population pharmacokinetics of ceftazidime in critically ill children: impact of cystic fibrosis. J Antimicrob Chemother. 2020 Aug 1;75(8):2232-2239. doi: 10.1093/jac/dkaa170.'}]}, 'descriptionModule': {'briefSummary': 'The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.', 'detailedDescription': 'The licensing process was introduced in order to ensure that medicines are safe, effective and of high quality. However, over 50% of children admitted to hospital in France and Europe will receive an unlicensed or off-label medicine. This occurs for most drugs in children less than 6 years of age. They represent a particularly vulnerable subgroup of the paediatric population.\n\nThere are major practical and ethical issues in relation to studying medicines in paediatric patients aged 5 years or less.\n\n* They represent only a small part of the population as compared to older children and adults, and the variation of specific types of diseases in this young subpopulation is higher than in the paediatric counterpart. There are major differences in drug disposition in the different age groups.\n* There is a need for suitable methodological approaches for clinical trials\n* There are major ethical issues It is essential, therefore, to recruit children from various regions in France in order to obtain a critical sample size of sufficient magnitude and to conduct scientific sound studies. This will be achieved by performing Pharm A, a population pharmacokinetic study of three different anti infectious agents (ceftazidime, ciprofloxacin, voriconazole) and identify covariates including pharmacogenetic biomarkers that explain pharmacokinetic variability.\n\nAfter parental informed consent, sampling strategy will be randomized depending on the drug and the age group (2 samples in patients below 2 years and 3 samples in patients from 2 to 5 years).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children aged 28 days to 11 years (\\< 12 years)\n* Receiving one of the following drugs for therapeutic reasons : ceftazidime, ciprofloxacin, voriconazole\n* Representative for the clinician, a condition requiring the use of these molecules\n* Informed consent signed by the two parents or legal representative\n* Child affiliated to the national social security system\n\nExclusion Criteria:\n\nNot Applicable'}, 'identificationModule': {'nctId': 'NCT01344512', 'acronym': 'PHARMA-A', 'briefTitle': 'Population Pharmacokinetics of Anti-infectious Drugs in Children', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)', 'orgStudyIdInfo': {'id': 'CHUBX 2010/36'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients treated with Ceftazidime', 'interventionNames': ['Drug: Ceftazidime']}, {'type': 'EXPERIMENTAL', 'label': 'Patients treated with Ciprofloxacin', 'interventionNames': ['Drug: Ciprofloxacin']}, {'type': 'EXPERIMENTAL', 'label': 'Patients treated with Voriconazole', 'interventionNames': ['Drug: Voriconazole']}], 'interventions': [{'name': 'Ceftazidime', 'type': 'DRUG', 'description': 'Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.', 'armGroupLabels': ['Patients treated with Ceftazidime']}, {'name': 'Ciprofloxacin', 'type': 'DRUG', 'description': 'Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.', 'armGroupLabels': ['Patients treated with Ciprofloxacin']}, {'name': 'Voriconazole', 'type': 'DRUG', 'description': 'Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.', 'armGroupLabels': ['Patients treated with Voriconazole']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU de Bordeaux, Hôpital Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '69500', 'city': 'Bron', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont Ferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '21079', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU de Dijon', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59037', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU Lille', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'AP-HM, Hôpital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34925', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Montpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'APHP - Hôpital NEcker', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'AP-HP - Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '86000', 'city': 'Poitiers', 'country': 'France', 'facility': 'CHU Poitiers', 'geoPoint': {'lat': 46.58261, 'lon': 0.34348}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'CHU Rouen', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '37044', 'city': 'Tours', 'country': 'France', 'facility': 'CHU tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}], 'overallOfficials': [{'name': 'Stéphanie Bui, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Bordeaux, France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}