Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-04-27 @ 12:31 PM
Study NCT ID:
NCT02162966
Status:
UNKNOWN
Last Update Posted:
2015-04-01
First Post:
2014-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of High Dose Colistin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003141', 'term': 'Communicable Diseases'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 330}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-03-31', 'studyFirstSubmitDate': '2014-05-21', 'studyFirstSubmitQcDate': '2014-06-12', 'lastUpdatePostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate safety of high dose Colistin', 'timeFrame': '7 to 21 days after giving Colistin', 'description': 'Evaluate the safety of high dose Colistin to treat MDRO infection in critically ill patients.\n\nThe safety of high dose Colistin will be determined by number of participants whom renal function will be deviated from the baseline after administering high dose of Colistin.'}], 'secondaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '7 days after the end of therapy or at 28 days after enrollment'}, {'measure': 'Ventilation free days', 'timeFrame': '28 days after enrollment'}, {'measure': 'Length of ICU stay', 'timeFrame': '28 days after enrollment'}, {'measure': 'Microbiological response', 'timeFrame': 'A day 7 and at the end of therapy', 'description': 'whole body cultures will be done at day 7 of treatment and at the end of therapy'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['colistin', 'ICU', 'critical care'], 'conditions': ['Infectious Diseases']}, 'descriptionModule': {'briefSummary': 'Colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against MDRO Gram-negative bacteria, such as as Pseudomonas aeruginosa, Acinetobacterbaumannii, and Klebsiella pneumonia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria:\n\n 1. Patient age more than or equal 18 years old.\n 2. Patient has clinical signs and symptoms of infection with suspected or proven infection due to Carbapenem resistant microorganism.\n 3. Patient was started with Empirical therapy of Colistin and positive MDRO within 5 days of empirical therapy.\n* Exclusion Criteria:\n\n 1. Patient age less than 18 years.\n 2. Pregnant patient.\n 3. If received Colistin treatment for less than 72 hours.\n 4. Renal Replacement Therapy.'}, 'identificationModule': {'nctId': 'NCT02162966', 'briefTitle': 'Safety and Efficacy Study of High Dose Colistin', 'organization': {'class': 'OTHER_GOV', 'fullName': 'King Saud Medical City'}, 'officialTitle': 'Use Of High Dose Colistin in Multi Drug Resistant Gram Negative Infections in Critically Ill Adult Patients. Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'KSMC-CCD-AFM-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose Colistin', 'description': 'High dose colistin protocol', 'interventionNames': ['Drug: High Dose Colistin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Dose Colistin', 'description': 'Standard dose of colistin', 'interventionNames': ['Drug: Standard Dose Colistin']}], 'interventions': [{'name': 'High Dose Colistin', 'type': 'DRUG', 'otherNames': ['colistin'], 'description': 'High Dose Colistin', 'armGroupLabels': ['High Dose Colistin']}, {'name': 'Standard Dose Colistin', 'type': 'DRUG', 'otherNames': ['Colistin'], 'description': 'Standard Dose Colistin', 'armGroupLabels': ['Standard Dose Colistin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00966', 'city': 'Riyadh', 'state': 'Riyadh Region', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Ahmed F Mady, PhD', 'role': 'CONTACT', 'email': 'afmady@ksmc.med.sa', 'phone': '00966547060770'}, {'name': 'Ahmad F Mady, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Basheer A Abdelrahman, PharmD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Muhammed A Rana, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Omar A Ramadan, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Abdulrahman M Al-Harthy, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'King Saud Medical City', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Ahmed F Mady, PhD', 'role': 'CONTACT', 'email': 'afmady@ksmc.med.sa', 'phone': '00966547060770'}, {'name': 'Basheer M Abdelrahman, pharmD', 'role': 'CONTACT', 'phone': '00966563516815'}], 'overallOfficials': [{'name': 'Ahmed F Mady, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'King Saud Medical City'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Saud Medical City', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}