Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-03-12 @ 5:30 AM
Study NCT ID:
NCT02045160
Status:
UNKNOWN
Last Update Posted:
2014-08-04
First Post:
2014-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011020', 'term': 'Pneumonia, Pneumocystis'}], 'ancestors': [{'id': 'D008172', 'term': 'Lung Diseases, Fungal'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D016720', 'term': 'Pneumocystis Infections'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-31', 'studyFirstSubmitDate': '2014-01-17', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2014-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'High performance liquid chromatography for drug plasma concentration', 'timeFrame': 'Participants will be followed for the duration of the treatment course, an expected average of 21 days', 'description': "The plasma concentration will not be measured until the patient's treatment course completed."}]}, 'conditionsModule': {'conditions': ['Pneumocystis Jirovecii Pneumonia']}, 'descriptionModule': {'briefSummary': 'In this study, we aim to investigate the incidence of the adverse reactions, the effectiveness and the gene polymorphism associated with the plasma level of sulfamethoxazole-trimethoprim and their metabolites (including N4-acetyl-sulfamethoxazole, sulfamethoxazole hydroxylamine and sulfamethoxazole-nitroso). And we also aim to investigate the factors associated with the sulfamethoxazole-trimethoprim induced acute psychosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who are treated in the National Taiwan University Hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* males and females aged 20 years or older\n* using oral or intravenous form of sulfamethoxazole-trimethoprim\n\nExclusion Criteria:\n\n* patients who are under 20 years of age'}, 'identificationModule': {'nctId': 'NCT02045160', 'briefTitle': 'A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'A Pharmacokinetic and Pharmacogenetic Study in Patients Receiving Sulfamethoxazole-trimethoprim Therapy', 'orgStudyIdInfo': {'id': '201312090RINC'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Sulfamethoxazole-trimethoprim treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '106', 'city': 'Taipei', 'state': 'TW', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'Taiwan', 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '106', 'city': 'Taipei', 'state': 'TW', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jin-Han Yang', 'role': 'CONTACT', 'email': 'r01451004@ntu.edu.tw'}, {'name': 'Shu-Wen Lin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Jin-Han Yang, Bachelor', 'role': 'CONTACT', 'email': 'r01451004@ntu.edu.tw', 'phone': '0975-103-277'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'National Taiwan University Hospital', 'investigatorFullName': 'National Taiwan University Hospital', 'investigatorAffiliation': 'National Taiwan University Hospital'}}}}