Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2026-04-14 @ 1:03 PM
Study NCT ID:
NCT02427932
Status:
COMPLETED
Last Update Posted:
2017-05-10
First Post:
2015-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D005839', 'term': 'Gentamicins'}], 'ancestors': [{'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'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': 'D000617', 'term': 'Aminoglycosides'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2015-04-14', 'studyFirstSubmitQcDate': '2015-04-22', 'lastUpdatePostDateStruct': {'date': '2017-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic Profiling to Measure Maternal Metabolism of Ampicillin and/or Gentamicin in Pregnancy', 'timeFrame': 'predose; after the full initial dose of the antibiotic has infused, at 5min, 15min, 30min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY', 'description': 'blood samples will be taken at the above timepoints; data analysis of all specimens will begin approx. 12-15 months from start of study'}], 'secondaryOutcomes': [{'measure': 'Profile of Neonatal Metabolism of Ampicillin and Gentamicin That Crosses the Placental Barrier', 'timeFrame': 'At delivery/upon cutting of umbilical cord', 'description': 'blood samples to be drawn at the above timepoint; data analysis of all specimens will begin approx. 12-15 months from start of study'}, {'measure': 'PD Modeling of Peripartum Patients Receiving Ampicillin and/or Gentamicin', 'timeFrame': 'predose; while dosing; post dose', 'description': 'subject will be observed for adverse events related to drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics (PK)', 'Pharmacodynamics (PD)'], 'conditions': ['Drug Metabolism During Pregnancy']}, 'descriptionModule': {'briefSummary': 'This study proposes to compare the metabolism of Ampicillin and Gentamicin by pregnant women to that of non-pregnant women; the placental transfer over time; and the subsequent metabolism of the transferred drug(s) in the neonate.', 'detailedDescription': 'Pregnant women who present to Labor and Delivery will be identified as potential participants based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy. The additional group of 20 non-pregnant women will also be identified based on Inclusion/Exclusion criteria and their need to receive Ampicillin and/or Gentamicin therapy.\n\nOnce identified, interested candidates will be fully informed of the study procedures, have all questions answered, and informed consent obtained.\n\nPregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery; or Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs. Dose times will be recorded.\n\nNon-pregnant participants will receive similar doses of either Ampicillin and/or Gentamicin, if not the same dose(s).\n\nFingerstick blood collection will be drawn from both populations at the following timepoints:\n\n* before the administration of Ampicillin, and/or\n* before the administration of Gentamicin\n* after the full initial dose of the antibiotic has infused, at 5 min, 15 min, 30 min, 2-3hr, 4-6hr, immediately prior to the next dose of drug, and at DELIVERY (a 5 minute window for each timepoint will be permitted) If delivery occurs prior to the 3 or 6 hr timepoints, fingerstick blood collection should continue\n\nSamples will be obtained on filter paper via the Dry Blood Spot (DBS) method, which is clinically appropriate for the purposes of this study.\n\nUmbilical venous and arterial blood will also be drawn for sampling from the placenta after delivery, and cutting of the umbilical cord.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women receiving ampicillin or gentamicin', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy, pregnant woman (28-42 weeks)\n* Generally healthy, non-pregnant female\n* Scheduled to receive Ampicillin and/or Gentamicin IV\n* Ages 18-55 years old\n* Relatively normal Comprehensive Metabolic Panel (if available), as evidenced by recent blood work\n* Able and willing to sign consent\n\nExclusion Criteria:\n\n* Women with known renal or hepatic impairment; preeclampsia; Diabetes, including Gestational; any medical condition that, in the opinion of the Investigator or research team member, could potentially interfere with the study objectives\n* Women who are participating in another study\n* Pregnant with multiples\n* BMI \\> 40'}, 'identificationModule': {'nctId': 'NCT02427932', 'briefTitle': 'Pharmacokinetic (PK) and Pharmacodynamic (PD) Modeling of Ampicillin and Gentamicin in Peripartum Patients', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'PK and PD Modeling of Ampicillin and Gentamicin in Peripartum Patients', 'orgStudyIdInfo': {'id': '29664'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pregnant/Ampicillin', 'description': 'pregnant participants who will receive Ampicillin for conditions such as Group B Streptococcus', 'interventionNames': ['Drug: Ampicillin']}, {'label': 'Non-pregnant/Ampicillin', 'description': 'non-pregnant participants who will receive Ampicillin for a qualifying hospital admission', 'interventionNames': ['Drug: Ampicillin']}, {'label': 'Pregnant and Non-pregnant/Ampicillin and Gentamicin', 'description': 'pregnant participants who will receive Ampicillin and Gentamicin for conditions such as chorioamnionitis; non-pregnant participants who will receive Ampicillin and Gentamicin for a qualifying hospital admission', 'interventionNames': ['Drug: Ampicillin and Gentamicin']}, {'label': 'Non-Pregnant/Gentamicin', 'description': 'non-pregnant participants who will receive Gentamicin for a qualifying hospital admission', 'interventionNames': ['Drug: Gentamicin']}], 'interventions': [{'name': 'Ampicillin', 'type': 'DRUG', 'description': 'Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery for Group B Strep prophylaxis; non-pregnant participants will receive Ampicillin for qualifying diagnosis', 'armGroupLabels': ['Non-pregnant/Ampicillin', 'Pregnant/Ampicillin']}, {'name': 'Ampicillin and Gentamicin', 'type': 'DRUG', 'description': 'Pregnant participants will receive Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs for chorioamnionitis; non-pregnant participants will receive for qualifying diagnosis', 'armGroupLabels': ['Pregnant and Non-pregnant/Ampicillin and Gentamicin']}, {'name': 'Gentamicin', 'type': 'DRUG', 'description': 'Prescribed to non-pregnant participants', 'armGroupLabels': ['Non-Pregnant/Gentamicin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': "Lucille Packard Children's Hospital", 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}], 'overallOfficials': [{'name': 'Brendan Carvalho, MBBCh', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}, {'name': 'David Drover, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'David Drover, MD', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MBBCh, FRCA, MDCH, Associate Professor, Dept. of Anesthesia', 'investigatorFullName': 'Brendan Carvalho', 'investigatorAffiliation': 'Stanford University'}}}}