Ignite Creation Date:
2025-12-25 @ 4:42 AM
Ignite Modification Date:
2025-12-26 @ 3:43 AM
Study NCT ID:
NCT03511118
Status:
RECRUITING
Last Update Posted:
2024-12-17
First Post:
2018-04-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D007741', 'term': 'Labetalol'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D009543', 'term': 'Nifedipine'}, {'id': 'D002981', 'term': 'Clindamycin'}, {'id': 'D010098', 'term': 'Oxycodone'}, {'id': 'D017963', 'term': 'Azithromycin'}, {'id': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D017294', 'term': 'Ondansetron'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}, {'id': 'D004318', 'term': 'Doxycycline'}, {'id': 'D064704', 'term': 'Levofloxacin'}, {'id': 'D008774', 'term': 'Methylphenidate'}, {'id': 'D018170', 'term': 'Sumatriptan'}, {'id': 'D015283', 'term': 'Citalopram'}, {'id': 'C004704', 'term': 'cyclobenzaprine'}, {'id': 'D005665', 'term': 'Furosemide'}, {'id': 'D000077206', 'term': 'Gabapentin'}, {'id': 'D006852', 'term': 'Hydrochlorothiazide'}, {'id': 'D006918', 'term': 'Hydroxyurea'}, {'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000077236', 'term': 'Topiramate'}, {'id': 'D014196', 'term': 'Trazodone'}, {'id': 'D000077562', 'term': 'Valganciclovir'}, {'id': 'D000069470', 'term': 'Venlafaxine Hydrochloride'}, {'id': 'D014700', 'term': 'Verapamil'}, {'id': 'C000606551', 'term': 'remdesivir'}, {'id': 'D053590', 'term': 'Interleukin 1 Receptor Antagonist Protein'}, {'id': 'C502936', 'term': 'tocilizumab'}, {'id': 'D016666', 'term': 'Fluvoxamine'}, {'id': 'D000658', 'term': 'Amoxicillin'}, {'id': 'D016642', 'term': 'Bupropion'}, {'id': 'D000068736', 'term': 'Duloxetine Hydrochloride'}, {'id': 'D006853', 'term': 'Hydrocodone'}, {'id': 'D000077287', 'term': 'Levetiracetam'}, {'id': 'D017374', 'term': 'Paroxetine'}, {'id': 'D002047', 'term': 'Buprenorphine'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D012457', 'term': 'Salicylamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D004095', 'term': 'Dihydropyridines'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D008034', 'term': 'Lincomycin'}, {'id': 'D055231', 'term': 'Lincosamides'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006027', 'term': 'Glycosides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D003061', 'term': 'Codeine'}, {'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004917', 'term': 'Erythromycin'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D061065', 'term': 'Polyketides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D015242', 'term': 'Ofloxacin'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D013424', 'term': 'Sulfanilamides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D003510', 'term': 'Cyclohexanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002740', 'term': 'Chlorothiazide'}, {'id': 'D001581', 'term': 'Benzothiadiazines'}, {'id': 'D049971', 'term': 'Thiazides'}, {'id': 'D014508', 'term': 'Urea'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D005632', 'term': 'Fructose'}, {'id': 'D006601', 'term': 'Hexoses'}, {'id': 'D009005', 'term': 'Monosaccharides'}, {'id': 'D000073893', 'term': 'Sugars'}, {'id': 'D007661', 'term': 'Ketoses'}, {'id': 'D010879', 'term': 'Piperazines'}, {'id': 'D011728', 'term': 'Pyridones'}, {'id': 'D015774', 'term': 'Ganciclovir'}, {'id': 'D000212', 'term': 'Acyclovir'}, {'id': 'D006147', 'term': 'Guanine'}, {'id': 'D007042', 'term': 'Hypoxanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D003511', 'term': 'Cyclohexanols'}, {'id': 'D000441', 'term': 'Hexanols'}, {'id': 'D005233', 'term': 'Fatty Alcohols'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D016207', 'term': 'Cytokines'}, {'id': 'D036341', 'term': 'Intercellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D010091', 'term': 'Oximes'}, {'id': 'D006898', 'term': 'Hydroxylamines'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D011427', 'term': 'Propiophenones'}, {'id': 'D007659', 'term': 'Ketones'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D000081', 'term': 'Acetamides'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Leftover specimens will be sent to NICHD repository for unknown future use'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-12', 'studyFirstSubmitDate': '2018-04-23', 'studyFirstSubmitQcDate': '2018-04-23', 'lastUpdatePostDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'M/P ratio', 'timeFrame': 'Until the infant becomes 180 days of age', 'description': 'Characterize the pharmacokinetics using maternal milk/plasma exposure ratio is calculated by dividing the BMS01 drug of interest breastmilk concentration by the BMS01 drug of interest in maternal plasma concentration.'}, {'measure': 'DID', 'timeFrame': 'Until the infant becomes 180 days of age', 'description': 'Pharmacokinetics is characterized by estimated daily infant dose-daily infant dose which estimates the quantity of drug delivered to an infant via breastmilk in a given day.'}, {'measure': 'RID', 'timeFrame': 'Until the infant becomes 180 days of age', 'description': 'Pharmacokinetics is characterized by relative infant dose is a method of relating the potential dose of the drug delivered to the infant to the typical therapeutic dose given to the mother.'}, {'measure': 'I/M ratio', 'timeFrame': 'Until the infant becomes 180 days of age', 'description': 'Pharmacokinetics is characterized using infant maternal/exposure ratio. IM ratio is calculated using the average infant plasma concentration of the BMS01 drug of interest and historical value of clearance in infants.'}], 'secondaryOutcomes': [{'measure': 'Safety profile of commonly used drugs in infants exposed to drugs in breastmilk', 'timeFrame': 'Until the infant becomes 180 days of age', 'description': 'see Cohort 1-31 for listing of drugs'}, {'measure': 'AE', 'timeFrame': 'Up until 180 days of age', 'description': 'Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Adverse Events(AE) which are collected at each time point when the study-specific procedure occurred and up until 1 hour after.'}, {'measure': 'SAE', 'timeFrame': 'Up until 180 days of age', 'description': 'Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Serious Adverse Events which are directly related to study procedures and were recorded from participants (infant or mother) at each time point when the study-specific procedure occurred and up until 1 hour after.'}, {'measure': 'ESI', 'timeFrame': 'Until the infant becomes 180 days of age', 'description': "Safety profile of commonly used drugs in infants exposed to drugs in breastmilk is characterized by Events of Special Interest(ESI) which include any pre-specified safety event that could be related to BMS01 drug of interest exposure. ESI's are only assessed for infants and only at study visits from the time the BMS01 DOI was initiated in mother and infant began breast milk feeding through the end of the study / infant age ≤ 180 days"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lactating Women on Select DOI', 'Breastfed Infants of Mothers on Select DOI']}, 'referencesModule': {'references': [{'pmid': '35076931', 'type': 'DERIVED', 'citation': 'Job KM, Dallmann A, Parry S, Saade G, Haas DM, Hughes B, Berens P, Chen JY, Fu C, Humphrey K, Hornik C, Balevic S, Zimmerman K, Watt K. Development of a Generic Physiologically-Based Pharmacokinetic Model for Lactation and Prediction of Maternal and Infant Exposure to Ondansetron via Breast Milk. Clin Pharmacol Ther. 2022 May;111(5):1111-1120. doi: 10.1002/cpt.2530. Epub 2022 Mar 5.'}]}, 'descriptionModule': {'briefSummary': 'Over half of women in the US who are breastfeeding their infants take prescription drugs. You are being asked to participate in this study because you are breastfeeding your infant and are currently taking, as part of your medical care, at least one of the drugs we are studying. We are interested in studying drugs commonly prescribed to women who are breastfeeding so we can learn more about the amount of drug that is transferred to breastmilk and estimate how much of drug that is consumed by breastfed infants.', 'detailedDescription': "The purpose of this study is to understand if the study drugs of interest are found in breastmilk and how much; to estimate the amount of drug that is consumed by breastfed infants and what effect this may have on infants; and to share what we learn with other researchers. The study drugs of interest have Food and Drug Administration (FDA) approval, but there is little or no information about the amount of drug found in the breastmilk of mothers who take them; the amount of drug that may be transferred to their infant's through breastmilk; or the effects this transfer may have on their infants. During this study we will ask to collect breastmilk and blood from mothers, and blood from infants, to measure the amount of study drug of interest in these body fluids. Results from this study will help researchers better understand how much of the study drug of interest is in your blood and breastmilk, and how much of the study drug of interest may be in your infant's blood because of breastfeeding."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Lactating women receiving DOIs per SOC, as prescribed by their healthcare providers, and their breastfed infants.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Lactating women who are receiving at least one DOI per SOC who are ≤180 days postpartum, and their infants (≤180 days of age) who receive maternal breastmilk.\n* Informed consent/HIPAA obtained, according to local IRB/REB/IEC guidelines, prior to any study-related procedures. Lactating women who are not legal adults and their breastfed infants may be enrolled if they assent to participate in the study and consent is obtained from their legal guardian according to local IRB/REB/IEC guidelines.\n\nExclusion Criteria:\n\n* Any concomitant condition which, in the opinion of the physicians providing patient care or the principal investigator conducting the study, would preclude a subject's participation in the study.\n* Known pregnancy during PK sampling."}, 'identificationModule': {'nctId': 'NCT03511118', 'briefTitle': 'Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Pharmacokinetics and Safety of Commonly Used Drugs in Lactating Women and Breastfed Infants', 'orgStudyIdInfo': {'id': 'Pro00088919'}, 'secondaryIdInfos': [{'id': 'HHSN275201000003I/27500051', 'type': 'OTHER_GRANT', 'domain': 'NICHD'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tranexamic acid (TXA)', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Tranexamic acid (TXA)']}, {'label': 'labetalol', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: labetalol']}, {'label': 'metformin', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: metformin']}, {'label': 'nifedipine', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: nifedipine']}, {'label': 'clindamycin', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: clindamycin']}, {'label': 'oxycodone', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: oxycodone']}, {'label': 'azithromycin', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: azithromycin']}, {'label': 'escitalopram', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: escitalopram']}, {'label': 'sertraline', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: sertraline']}, {'label': 'ondansetron', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: ondansetron']}, {'label': 'Ciprofloxacin', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Ciprofloxacin']}, {'label': 'Doxycycline', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Doxycycline']}, {'label': 'Levofloxacin', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Levofloxacin']}, {'label': 'Methylphenidate', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Methylphenidate']}, {'label': 'Sumatriptan', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Sumatriptan']}, {'label': 'Citalopram', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Citalopram']}, {'label': 'Cyclobenzaprine', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Cyclobenzaprine']}, {'label': 'Furosemide', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Furosemide']}, {'label': 'Gabapentin', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Gabapentin']}, {'label': 'Hydrochlorothiazide', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Hydrochlorothiazide']}, {'label': 'Hydroxyurea', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Hydroxyurea']}, {'label': 'Rosuvastatin', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Rosuvastatin']}, {'label': 'Topiramate', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Topiramate']}, {'label': 'Trazodone', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Trazodone']}, {'label': 'Valganciclovir', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Valganciclovir']}, {'label': 'Venlafaxine', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Venlafaxine']}, {'label': 'Verapamil', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Verapamil']}, {'label': 'Remdesivir', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Remdesivir']}, {'label': 'Anakinra', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Anakinra']}, {'label': 'Tocilizumab', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Tocilizumab']}, {'label': 'Fluvoxamine', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Fluvoxamine']}, {'label': 'Amoxicillin', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Amoxicillin']}, {'label': 'Bupropion', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Bupropion']}, {'label': 'Buprenorphine', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Buprenorphine']}, {'label': 'Hydrocodone', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Hydrocodone']}, {'label': 'Levetiracetam', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Levetiracetam']}, {'label': 'Paroxetine', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Paroxetine']}, {'label': 'Duloxetine', 'description': 'No intervention, observational study and PK collections The study objectives are to characterize the PK and safety profile of DOIs that are commonly administered to lactating women.\n\nThe primary focus of this analysis will be to determine drug concentrations in breastmilk and to estimate the relative infant dose.', 'interventionNames': ['Drug: Duloxetine']}], 'interventions': [{'name': 'Tranexamic acid (TXA)', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Tranexamic acid (TXA)']}, {'name': 'labetalol', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['labetalol']}, {'name': 'metformin', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['metformin']}, {'name': 'nifedipine', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['nifedipine']}, {'name': 'clindamycin', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['clindamycin']}, {'name': 'oxycodone', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['oxycodone']}, {'name': 'azithromycin', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['azithromycin']}, {'name': 'escitalopram', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['escitalopram']}, {'name': 'sertraline', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['sertraline']}, {'name': 'ondansetron', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['ondansetron']}, {'name': 'Ciprofloxacin', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Ciprofloxacin']}, {'name': 'Doxycycline', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Doxycycline']}, {'name': 'Levofloxacin', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Levofloxacin']}, {'name': 'Methylphenidate', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Methylphenidate']}, {'name': 'Sumatriptan', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Sumatriptan']}, {'name': 'Citalopram', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Citalopram']}, {'name': 'Cyclobenzaprine', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Cyclobenzaprine']}, {'name': 'Furosemide', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Furosemide']}, {'name': 'Gabapentin', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Gabapentin']}, {'name': 'Hydrochlorothiazide', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Hydrochlorothiazide']}, {'name': 'Hydroxyurea', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Hydroxyurea']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Rosuvastatin']}, {'name': 'Topiramate', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Topiramate']}, {'name': 'Trazodone', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Trazodone']}, {'name': 'Valganciclovir', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Valganciclovir']}, {'name': 'Venlafaxine', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Venlafaxine']}, {'name': 'Verapamil', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Verapamil']}, {'name': 'Remdesivir', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Remdesivir']}, {'name': 'Anakinra', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Anakinra']}, {'name': 'Tocilizumab', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Tocilizumab']}, {'name': 'Fluvoxamine', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Fluvoxamine']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Amoxicillin']}, {'name': 'Bupropion', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Bupropion']}, {'name': 'Duloxetine', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Duloxetine']}, {'name': 'Hydrocodone', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Hydrocodone']}, {'name': 'Levetiracetam', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Levetiracetam']}, {'name': 'Paroxetine', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Paroxetine']}, {'name': 'Buprenorphine', 'type': 'DRUG', 'description': "Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.", 'armGroupLabels': ['Buprenorphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kerri Bertrand', 'role': 'CONTACT', 'email': 'kdutcher@ucsd.edu', 'phone': '858-246-1713'}, {'name': 'Gretchen Bandoli', 'role': 'CONTACT', 'email': 'gbandoli@ucsd.edu', 'phone': '858-246-1733'}, {'name': 'Christina Chambers, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Michelle Leff', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California-San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jose Navarro', 'role': 'CONTACT', 'email': 'jdnavarro@llu.edu', 'phone': '909-558-5830'}, {'name': 'Stephanie Wells', 'role': 'CONTACT', 'email': 'scwells@llu.edu', 'phone': '909-558-5830'}, {'name': 'Adrian Lavery', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Larry Ngo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Loma Linda University Health', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60614', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Fearn', 'role': 'CONTACT', 'email': 'lfearn@luriechildrens.org', 'phone': '312-227-6280'}, {'name': 'Mayra Gomez', 'role': 'CONTACT', 'email': 'mmgomez@luriechildrens.org', 'phone': '312-227-8274'}, {'name': 'William Muller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ann and Robert H. Lurie Childrens Hospital of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Indiana University Health', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Beverly Vermace', 'role': 'CONTACT', 'email': 'beverly-vermace@uiowa.edu', 'phone': '319-356-4587'}, {'name': 'Maureen Austin', 'role': 'CONTACT', 'email': 'maureen-austin@uiowa.edu', 'phone': '319-356-7025'}, {'name': 'Temitope Awelewa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Iowa Hospitals and Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Quast Emily', 'role': 'CONTACT', 'email': 'emily.quast@childrensmn.org', 'phone': '612-813-6864'}, {'name': 'Molly fisher', 'role': 'CONTACT', 'email': 'molly.fisher@childrensmn.org', 'phone': '612-813-6864'}, {'name': 'Andrea Lampland, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Children's Hospital and Clinics - Minneapolis", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of New Mexico, Health Sciences Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of North Carolina Hospital', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Thelma Fitzgerald', 'role': 'CONTACT', 'email': 'thelma.fitzgerald@duke.edu', 'phone': '919-684-1224'}, {'name': 'Jordynn Akins', 'role': 'CONTACT', 'email': 'jordynn.akins@duke.edu', 'phone': '919-681-0013'}, {'name': 'Brenna Hughes, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Maternal and Fetal Medicine', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Monica Rincon', 'role': 'CONTACT', 'email': 'rincon@ohsu.edu', 'phone': '503-494-8748'}, {'name': 'Daniela Cramer', 'role': 'CONTACT', 'email': 'cramerda@ohsu.edu', 'phone': '503-494-8742'}, {'name': 'Nicole Marshall', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Karen Gibbins', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania Department of Maternal Fetal Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Matthew Butoryak', 'role': 'CONTACT', 'email': 'butoryakm@upmc.edu', 'phone': '412-692-8181'}, {'name': 'Anne-Marie Rick, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Pittsburgh School of Medicine', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Nichole Campbell, APRN, NP-C', 'role': 'CONTACT', 'email': 'Nichole.Campbell@ttuhsc.edu', 'phone': '806-414-9799'}, {'name': 'Kaytlin Krutsch, PharnD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Teresa Baker, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Texas Tech University Health Sciences Center School of Medicine.', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Leah McCoy', 'role': 'CONTACT', 'email': 'lemccoy@utmb.edu', 'phone': '409-747-1761'}, {'name': 'Lizzet Aguillon', 'role': 'CONTACT', 'email': 'liaguill@utmb.edu', 'phone': '409-772-0305'}, {'name': 'Gayle Olson, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Medical Branch - Galveston', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Josephine Turner', 'role': 'CONTACT', 'email': 'josephine.turner@uth.tmc.edu', 'phone': '713-513-6419'}, {'name': 'Pamela Berens, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77054', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Olaide Balogun, MD', 'role': 'CONTACT', 'email': 'olaide.ashimibalogun@pediatrix.com', 'phone': '832-418-7091'}, {'name': 'Ashley Lozano', 'role': 'CONTACT', 'email': 'Ashley.Lozano@hcahealthcare.com', 'phone': '346-528-5134'}], 'facility': "The Women's Hospital of Texas", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Janette Rodela, RN', 'role': 'CONTACT', 'email': 'Janette.Rodela@HCAhealthcare.com', 'phone': '615-344-9551'}, {'name': 'Olaide Balogun, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kaashif Ahmad, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kelly Christensen', 'role': 'CONTACT', 'email': 'kelly.vorwaller@hsc.utah.edu', 'phone': '801-674-7234'}, {'name': 'Kathleen Job', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lauren Theilen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '98195-7630', 'city': 'Seattle', 'state': 'Washington', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'status': 'COMPLETED', 'country': 'Canada', 'facility': 'Lawson Health Research Institute', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}, {'zip': 'H3T IC5', 'city': 'Montreal', 'state': 'Quebec', 'status': 'COMPLETED', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire Sainte-Justine', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'centralContacts': [{'name': 'Emily Forgey', 'role': 'CONTACT', 'email': 'emily.forgey@duke.edu', 'phone': '919-660-8720'}, {'name': 'Cheryl Alderman', 'role': 'CONTACT', 'email': 'cheryl.alderman@duke.edu', 'phone': '919-966-8349'}], 'overallOfficials': [{'name': 'Kanecia Zimmerman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Emmes Company, LLC', 'class': 'INDUSTRY'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pediatrics', 'investigatorFullName': 'Kanecia Obie Zimmerman', 'investigatorAffiliation': 'Duke University'}}}}