Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 12:27 AM
Study NCT ID:
NCT00300560
Status:
UNKNOWN
Last Update Posted:
2006-05-22
First Post:
2006-03-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003091', 'term': 'Colistin'}], 'ancestors': [{'id': 'D011113', 'term': 'Polymyxins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055666', 'term': 'Lipopeptides'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D023181', 'term': 'Antimicrobial Cationic Peptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000089882', 'term': 'Antimicrobial Peptides'}, {'id': 'D052899', 'term': 'Pore Forming Cytotoxic Proteins'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 152}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-03', 'completionDateStruct': {'date': '2006-12'}, 'lastUpdateSubmitDate': '2006-05-19', 'studyFirstSubmitDate': '2006-03-07', 'studyFirstSubmitQcDate': '2006-03-08', 'lastUpdatePostDateStruct': {'date': '2006-05-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical response'}], 'secondaryOutcomes': [{'measure': 'Microbiological response'}]}, 'conditionsModule': {'keywords': ['ESBL-producing E.coli Infections', 'ESBL-producing Klebsiella pneumoniae Infections', 'Colistin'], 'conditions': ['Infections']}, 'descriptionModule': {'briefSummary': 'In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.', 'detailedDescription': 'In patients with documented ESBL-producing E.coli and Klebsiella pneumoniae will be allocated to receive colistin or conventional antibiotic regimen.The primary outcome is clinical response and secondary outcomes are microbiological response and adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 yr.\n* Hospitalized to Siriraj Hospital\n* Infections with ESBL-producing E.coli or K.pneumoniae\n* Consent informed consent\n\nExclusion Criteria:\n\n* Pregnancy or lactating mother\n* Colistin allergy\n* Neurologic diseases'}, 'identificationModule': {'nctId': 'NCT00300560', 'briefTitle': 'Efficacy and Safety of Colistin for Therapy of Infections Caused by ESBL Producing K.Pneumoniae or E.Coli', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Efficacy and Safety of Colistin for Therapy of Infections Caused by Extended Spectrum Beta-Lactamase(ESBL) Producing Klebsiella Pneumoniae or Escherichia Coli', 'orgStudyIdInfo': {'id': 'SirirajCEU49-004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Colistin', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Sunee Thanakhumtorn, RN', 'role': 'CONTACT', 'email': 'srstn@mahidol.ac.th', 'phone': '662 4197000', 'phoneExt': '6616'}, {'name': 'Visanu Thamlikitkul, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pornpan Koomanachai, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hutsaya Tantipong, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Sriripetcharat Mekviwattanawong, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pasri Maharomn, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pinyo Rattanaumpawan, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Division of Infectious disease and Tropical Medicine, Department of Medicine, Faculty of Medicine Siriraj Hospital'}], 'centralContacts': [{'name': 'Visanu Thamlikitkul, MD', 'role': 'CONTACT', 'email': 'sivth@mahidol.ac.th', 'phone': '662 419 7000', 'phoneExt': '6626'}], 'overallOfficials': [{'name': 'Visanu Thamlikitkul, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}}}}