Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT04764058
Status:
UNKNOWN
Last Update Posted:
2021-02-21
First Post:
2021-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Colistin Based Antibiotic Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077728', 'term': 'Cilastatin, Imipenem Drug Combination'}, {'id': 'D000077731', 'term': 'Meropenem'}], 'ancestors': [{'id': 'D015378', 'term': 'Imipenem'}, {'id': 'D013845', 'term': 'Thienamycins'}, {'id': 'D015780', 'term': 'Carbapenems'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015377', 'term': 'Cilastatin'}, {'id': 'D003521', 'term': 'Cyclopropanes'}, {'id': 'D003516', 'term': 'Cycloparaffins'}, {'id': 'D006840', 'term': 'Hydrocarbons, Alicyclic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2017-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-02-18', 'studyFirstSubmitDate': '2021-02-15', 'studyFirstSubmitQcDate': '2021-02-18', 'lastUpdatePostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic Parameters Measurement ,heart beating rate.', 'timeFrame': '2 year', 'description': 'the efficacy and safety of antibiotic combination containing Colistin. We will monitor the heart beating rate.'}, {'measure': 'Hemodynamic Parameters Measurement ,body temperature', 'timeFrame': '2 year', 'description': 'the efficacy and safety of antibiotic combination containing Colistin. We will monitor the body temperature'}, {'measure': 'Hemodynamic Parameters Measurement ,respiratory rate.', 'timeFrame': '2 year', 'description': 'the efficacy and safety of antibiotic combination containing Colistin. We will monitor the respiratory rate.'}, {'measure': 'Hemodynamic Parameters Measurement ,blood pressure', 'timeFrame': '2 year', 'description': 'the efficacy and safety of antibiotic combination containing Colistin. We will monitor the blood pressure'}, {'measure': 'Hemodynamic Parameters Measurement ,partial oxygen saturation pressure', 'timeFrame': '2 year', 'description': 'the efficacy and safety of antibiotic combination containing Colistin. We will monitor the partial oxygen saturation pressure'}, {'measure': 'Hemodynamic Parameters Measurement and Septic Markers, serum lactate', 'timeFrame': '2 year', 'description': 'the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum lactate'}, {'measure': 'Hemodynamic Parameters Measurement ,serum creatinine', 'timeFrame': '2 year', 'description': 'the efficacy and safety of antibiotic combination containing Colistin. We will monitor the serum creatinine'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Septicemia', 'Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit.\n\nThe main outcome measure is clinical and microbiological responses to therapy.\n\nThe secondary outcome is the occurrence of adverse events during Colistin combination treatment.', 'detailedDescription': "Patients and Methods\n\nDesign of the study:\n\n\\- Prospective, Randomized, interventional study.\n\nSetting:\n\n\\- The study will be conducted in the pediatric surgery intensive care unit in Children's Hospitals, Ain Shams University, Cairo, Egypt.\n\nSubjects:\n\n\\- Pediatric patients admitted in pediatric surgery intensive care unit.\n\nInclusion criteria:\n\nAll children with culture-proven nosocomial infections due to multidrug resistance gram-negative organisms\n\nExclusion criteria:\n\n1. Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded.\n2. Patients who will receive \\<6 doses of intravenous Colistin will be excluded.\n3. Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.\n\nMethodology:\n\n\\- Sixty pediatric patients admitted to the pediatric surgery intensive care unit will be enrolled in the study and will be randomly assigned to either Group I or Group II\n\nGroup I: Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24 Colistin formulation consists of 2 million IU per vial. Group II: Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬. 22,24\n\nFor all patients the following data will be collected:\n\n1. Demographic data (age, gender, weight).\n2. The risk factors for nosocomial infections.\n3. Pediatric surgery intensive care unit stay.\n4. Type of surgeries performed.\n5. Site of isolation of organisms.\n6. The dose and duration of therapy.\n7. Serum creatinine levels will be assessed at baseline, once weekly and at the end of Colistin combination therapy.\n8. Nephrotoxic co-medication monitoring.\n9. Clinical (resolution of signs and symptoms of infection) and\n10. microbiological (bacteriologic responses) outcomes will be evaluated during treatment and at the end of the treatment.\n\nAccording to the inclusion and exclusion criteria, the demographic data for the intended ICU patients was collected, then the sample was withdrawn from the infected site to be cultured on specific culture media (such as blood agar, MacConkey agar, Chocolate agar), and identification of the isolated microorganism was detected by biochemical tests and Vitek-2 compact system whenever required. Antimicrobial sensitivity to Colistin was tested using the micro broth dilution method, in order to be evaluated in Colistin therapy. After culture-proven, the drug was given, either IV Colistin-Imipenem/Cilastatin as a combination or Imipenem/Cilastatin as a monotherapy. Throughout this step, the hemodynamic parameters were measured during the process of treatment, without neglecting the serum creatinine level to detect any nephrotoxicity.\n\nWe assure the right drug handling, dosing, dispensing, and monitoring. At the end of the treatment, the duration and length of PICU stay were recorded.\n\nThe decision and/or conclusion of treatment failure and/ or success was based upon the worsening and/or improvement of the patients' parameters and their situation including the results of the microbiological examination before and after the intervention"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All children with culture proven nosocomial infections due to multidrug resistance gram-negative organisms\n\nExclusion Criteria:\n\n* 1\\. Patients who started on Colistin treatment outside the pediatric surgery intensive care unit and transferred to the unit afterward will be excluded.\n\n 2\\. Patients who will receive \\<6 doses of intravenous Colistin will be excluded.\n\n 3\\. Patients received Imipenem or Colistin-Imipenem compination as empirical antibiotic.'}, 'identificationModule': {'nctId': 'NCT04764058', 'briefTitle': 'Efficacy and Safety of Colistin Based Antibiotic Therapy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Efficacy and Safety of Colistin Based Antibiotic Therapy for Multidrug Resistant Gram Negative Infections in Pediatric Intensive Care Unit', 'orgStudyIdInfo': {'id': '210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Montherapy', 'description': 'Thirty patients will receive IV Imipenem in doses of 15 to 25 mg/kg every 6 hours', 'interventionNames': ['Drug: Tienam 500', 'Device: Infusion']}, {'type': 'OTHER', 'label': 'Combination', 'description': 'Thirty patients will receive IV Colistin in dosages of 50,000-75,000 IU/kg/day in three divided doses, infused IV in 10mL normal saline over 30 minutes with IV Imipenem in doses of 15 to 25 mg/kg every 6 hours¬.21,22,24 Colistin formulation consists of 2 million IU per vial.', 'interventionNames': ['Drug: Tienam 500', 'Device: Infusion']}], 'interventions': [{'name': 'Tienam 500', 'type': 'DRUG', 'otherNames': ['Meronem'], 'description': 'Imipenem and cilastatin sodium', 'armGroupLabels': ['Combination', 'Montherapy']}, {'name': 'Infusion', 'type': 'DEVICE', 'description': 'Health caregivers give the drug to the patients and monitoring the infusion rate', 'armGroupLabels': ['Combination', 'Montherapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams Univesity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'AHMED S ATTIA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Heliopolis University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Ahmed Saeed Attia Mancy', 'investigatorAffiliation': 'Ain Shams University'}}}}