Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02898961
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2016-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000583', 'term': 'Amikacin'}, {'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D007612', 'term': 'Kanamycin'}, {'id': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2016-09-01', 'studyFirstSubmitQcDate': '2016-09-08', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence/absence of target peak serum concentration of aminosides', 'timeFrame': '30 minutes after the end of the infusion.', 'description': 'Achievement of targeted peak serum concentration?'}]}, 'conditionsModule': {'conditions': ['Sepsis']}, 'referencesModule': {'references': [{'pmid': '26429564', 'type': 'RESULT', 'citation': 'Roger C, Nucci B, Louart B, Friggeri A, Knani H, Evrard A, Lavigne JP, Allaouchiche B, Lefrant JY, Roberts JA, Muller L. Impact of 30 mg/kg amikacin and 8 mg/kg gentamicin on serum concentrations in critically ill patients with severe sepsis. J Antimicrob Chemother. 2016 Jan;71(1):208-12. doi: 10.1093/jac/dkv291. Epub 2015 Oct 1.'}]}, 'descriptionModule': {'briefSummary': 'Low first-dose peak serum concentrations of amikacin and gentamicin are commonly reported in ICU patients. The present study aimed to assess whether 30 mg/kg amikacin or 8 mg/kg gentamicin achieved target concentrations in ICU patients with severe sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ICU patient with severe sepsis\n* Treated with aminoglycosides\n\nExclusion Criteria:\n\n* Renal replacement therapy\n* Allergy to aminoglycosides\n* Confirmed and/or suspected to have myasthenia\n* ICU-acquired neuromuscular disorder\n* Under guardianship\n* Prisoners\n* The patient has already participated in the present protocol'}, 'identificationModule': {'nctId': 'NCT02898961', 'acronym': 'Aminoside_II', 'briefTitle': 'Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Impact of 30 mg/kg Amikacin and 8 mg/kg Gentamicin on Serum Concentrations in Critically Ill Patients With Severe Sepsis', 'orgStudyIdInfo': {'id': 'LOCAL/2015/JYL-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The study population', 'description': 'ICU patients with severe sepsis treated with aminoglycosides were recruited.\n\nIntervention: 30 mg/kg amikacin or 8 mg/kg gentamicin', 'interventionNames': ['Drug: 30 mg/kg amikacin or 8 mg/kg gentamicin']}], 'interventions': [{'name': '30 mg/kg amikacin or 8 mg/kg gentamicin', 'type': 'DRUG', 'description': 'In order to improve the achievement of target peak concentrations, either 30 mg/kg amikacin or 8 mg/kg gentamicin was prescribed in ICU patients with severe sepsis.\n\nIn combination with broad-spectrum antibiotics, according to the suspected pathogens and local clinical practice, 30 mg/kg amikacin or 8 mg/kg gentamicin was given (30 min intravenous infusion; the dosage ampoule was systematically emptied with a 5 ml flush). The peak serum concentration sampling occurred 30 minutes after the end of the infusion.', 'armGroupLabels': ['The study population']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}