Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-01-01 @ 9:32 PM
Study NCT ID:
NCT01182259
Status:
UNKNOWN
Last Update Posted:
2010-08-16
First Post:
2010-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Incidence and Risk Factors of Side Effects During the Initial Phase of Rifater Therapy - a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014376', 'term': 'Tuberculosis'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'lastUpdateSubmitDate': '2010-08-13', 'studyFirstSubmitDate': '2010-08-13', 'studyFirstSubmitQcDate': '2010-08-13', 'lastUpdatePostDateStruct': {'date': '2010-08-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-16', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Tuberculosis']}, 'descriptionModule': {'briefSummary': 'Tuberculosis remains one of the largest health problems in the world today. Multidrug therapy is necessary to cure tuberculosis patients and to prevent the selection of drug-resistant mutants, however, which may increase the incidence of side effects during the course of treatment. These side effects may be mild as well as fatal. A severe side effect against one of the anti-TB drugs, which influences drug compliance, may lead to the discontinuation of that drug. At the same time, the risk of treatment failure and relapse are higher. Therefore monitoring the rate of anti-TB drugs induced adverse effects and the related risk factors is crucial. Awareness of the risk groups may decrease the incidence of serious drug-related side effects and medical cost.\n\nThe fixed-dose combinations (FDCs) of tablets against tuberculosis is now being recommended by WHO, which simplify the prescription of drugs and prevent the development of drug resistance. However, the FDC regimen is not consistent with the dosages that are usually given, the higher risk of drug toxicity and adverse reactions should be considered. To our knowledge, there was no report to assess the adverse effects of FDC anti-TB drugs in Taiwan. The aim of the present study is to investigate the current incidence of side effects and the risk factors related to FDC drugs for side effects during the initial phase of therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Newly diagnosed TB patient in E-DA hospital', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Newly diagnosed pulmonary TB and extrapulmonary TB patients\n2. No previous anti-TB drugs treatment\n3. Age more than 18years old\n\nExclusion Criteria:\n\n1. Expected life \\< 6months\n2. Baseline AST and ALT \\> 3 fold upper limit of normal (ULN) or total bilirubin\\>2mg/dl\n3. Age less than 18years old'}, 'identificationModule': {'nctId': 'NCT01182259', 'briefTitle': 'The Incidence and Risk Factors of Side Effects During the Initial Phase of Rifater Therapy - a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'E-DA Hospital'}, 'orgStudyIdInfo': {'id': 'JTWu002'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kaohsiung City', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Chien-Tung Chiu', 'role': 'CONTACT', 'email': 'chiuct168@gmail.com', 'phone': '886-7-615-0011', 'phoneExt': '2980'}, {'name': 'Yuan-Kun Tu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'E-DA hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Jiun-Ting Wu, MD', 'role': 'CONTACT', 'email': 'ed103621@edah.org.tw', 'phone': '886-7-615-0011', 'phoneExt': '2980'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'E-DA Hospital', 'class': 'OTHER'}}}}