Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-02-20 @ 6:41 PM
Study NCT ID:
NCT02042261
Status:
COMPLETED
Last Update Posted:
2016-03-03
First Post:
2014-01-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055985', 'term': 'Latent Tuberculosis'}], 'ancestors': [{'id': 'D014376', 'term': 'Tuberculosis'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000085343', 'term': 'Latent Infection'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-01', 'studyFirstSubmitDate': '2014-01-20', 'studyFirstSubmitQcDate': '2014-01-20', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rifampicin concentration in relationship to MIC over 10', 'timeFrame': '2 weeks'}], 'secondaryOutcomes': [{'measure': 'Cure rate on Clinical follow up (according to WHO criteria) in relation to rifampicin concentration at week 2', 'timeFrame': '1 year'}, {'measure': 'Sputum Culture conversion in relation to rifampicin, isoniazid and pyrazinamid concentration week 2', 'timeFrame': '2 and 8 weeks'}, {'measure': 'TB-score in relation to rifampicin, isoniazid and pyrazinamid concentration week 2', 'timeFrame': '8 weeks'}, {'measure': 'Time to positive Culture (TTP) in relation to isoniazid, ethambutol and pyrazinamid serum concentration and minimal inhibitory concentration (MIC)', 'timeFrame': '2 and 8 weeks'}, {'measure': 'Time to positive Culture (TTP) in relation to rifampicin serum concentration and minimal inhibitory concentration (MIC)', 'timeFrame': '2weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Active Tuberculosis']}, 'referencesModule': {'references': [{'pmid': '30124844', 'type': 'DERIVED', 'citation': 'Niward K, Davies Forsman L, Bruchfeld J, Chryssanthou E, Carlstrom O, Alomari T, Carlsson B, Pohanka A, Mansjo M, Jonsson Nordvall M, Johansson AG, Eliasson E, Werngren J, Paues J, Simonsson USH, Schon T. Distribution of plasma concentrations of first-line anti-TB drugs and individual MICs: a prospective cohort study in a low endemic setting. J Antimicrob Chemother. 2018 Oct 1;73(10):2838-2845. doi: 10.1093/jac/dky268.'}]}, 'descriptionModule': {'briefSummary': 'Drug resistant TB is increasing and in order to enchance the efficacy of the current drugs, individualized therapy using plasma drug concentrations and minimal inhibitory concentration (MIC) determination may be of importance. This concept is defined as therapeutic drug monitoring (TDM).\n\nIn this pilot study our hypothesis is that the ratio between MIC and drug concentration data is correlated to the bacterial load measured as time to positive liquid culture (TTP).\n\nIn two sites in Sweden (Linköping and Karolinska Hospital Solna, Stockholm), 25 patients with pulmonary tuberculosis will be recruited. MIC-determination of Mycobacterium tuberculosis will be performed in BACTEC 960 MGIT and drug concentration will be determined at 2, 4 and 12 weeks after treatment initiation using LC-MS/MS methodology. Sputum cultures will be obtained at 0, 2 days, 7 days, 2 weeks, 4 weeks and 8 weeks and TTP will be measured in duplicate samples. Clinical follow up according to WHO criteria will be performed 1 year after completion of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed patients with culture verified tuberculosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge\\>18 years, culture verified tuberculosis\n\nExclusion Criteria:\n\nOther infectious diseases other than HIV or tuberculosis'}, 'identificationModule': {'nctId': 'NCT02042261', 'briefTitle': 'The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'The Role of Therapeutic Drug Monitoring in Tuberculosis - a Pilot Study', 'orgStudyIdInfo': {'id': 'TB-TDM'}}, 'contactsLocationsModule': {'locations': [{'zip': '581 85', 'city': 'Linköping', 'state': 'Linköping', 'country': 'Sweden', 'facility': 'Dept of Infectious Diseases', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}, {'zip': '17671', 'city': 'Stockholm', 'state': 'Stockholm County', 'country': 'Sweden', 'facility': 'Dept of Infectious Diseases, TB-unit, Karolinska Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Katarina Niward, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Schon', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, {'name': 'Karolinska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD PhD', 'investigatorFullName': 'Thomas Schon', 'investigatorAffiliation': 'Linkoeping University'}}}}