Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-29 @ 9:18 AM
Study NCT ID:
NCT06843668
Status:
RECRUITING
Last Update Posted:
2025-07-04
First Post:
2025-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Masking Description'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a prospective, single blind, randomized, comparative intervention study .'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-12-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-10-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-07-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical and microbiological success in eradication of infection reported as the number and percentage of patients with successful clinical improvement and microbiological clearance (Efficacy).', 'timeFrame': '14 days post colistin initiation.', 'description': 'having a white blood cell count (WBC) of less than 12,000 cells/mm3 or a ≥ 25% reduction in WBC, being afebrile for ≥ 48 h,.\n\n• Microbiological clearance will be defined as eradication of the original causative organism from subsequent blood cultures by day 14 of therapy.'}], 'secondaryOutcomes': [{'measure': 'Nephrotoxicity (Safety)', 'timeFrame': '14 days', 'description': 'nephrotoxicity was defined as doubling of baseline serum creatinine level or drop-in baseline creatinine clearance rate by ≥50%.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critical Ill Patients', 'Multi Drug Resistant']}, 'referencesModule': {'references': [{'pmid': '16931410', 'type': 'BACKGROUND', 'citation': 'Li J, Nation RL, Turnidge JD, Milne RW, Coulthard K, Rayner CR, Paterson DL. Colistin: the re-emerging antibiotic for multidrug-resistant Gram-negative bacterial infections. Lancet Infect Dis. 2006 Sep;6(9):589-601. doi: 10.1016/S1473-3099(06)70580-1.'}, {'pmid': '26302835', 'type': 'BACKGROUND', 'citation': 'Maraki S, Mantadakis E, Nioti E, Samonis G. Susceptibility of 2,252 Pseudomonas aeruginosa Clinical Isolates Over 4 Years to 9 Antimicrobials in a Tertiary Greek Hospital. Chemotherapy. 2014;60(5-6):334-41. doi: 10.1159/000437252. Epub 2015 Aug 18.'}]}, 'descriptionModule': {'briefSummary': 'Nosocomial infections caused by multi-drug-resistant (MDR) and extensively drug-resistant (XDR) Gram-negative pathogens represent a major threat worldwide. The increasing trend of multi-drug resistance in Gram-negative bacteria (MDR-GNB) poses a particularly acute challenge to health systems especially in critically ill patients.\n\nPatients in intensive care units (ICUs) have encountered an increasing emergence and spread of antibiotic-resistant pathogens. In Saudi Arabia mainly MDR-GNB such as Acinetobacter Baumannii, Pseudomonas Aeruginosa, Klebsiella Pnemoniae and Enterobacter are observed in ICUs.\n\nPolymyxins are the last line therapy in the treatment of infection caused by these MDR-GNB. Colistin is the most widely used polymyxin antibiotic, it is administered as inactive prodrug colistimethate sodium (CMS) that is hydrolyzed to an active moiety of colistin base activity (CBA). It acts as cationic detergent and damages bacterial cytoplasmic membrane causing leaking of intracellular substances and then cell death.\n\nDuring the first years of their use, polymyxin-associated neurotoxicity occurred in patients with an incidence as high as 27% following parenteral administration. However, other retrospective clinical trials have not exposed neurotoxicity to be a major concern. On the other hand, nephrotoxicity is by far the most common and dose-limiting side effect associated with parenteral polymyxins, with incidence rates in patients as high as 60%. Despite the high incidence of colistin induced nephrotoxicity, in 2012, the World Health Organization (WHO) reclassified polymyxins as critically important for the management of MDR-GNB infection, renewing the interest in these antibiotics.\n\nTo the best of our knowledge no study compared the efficacy and safety of both dosing strategies in critically ill patients. Moreover, there is still a lack of evidence on the efficacy and safety of both dosing strategies in obese patients. Therefore, this study aims at comparing the efficacy and toxicity of both strategies in colistin dosing (the fixed dose and the weight-based dosing) in obese patients and non- obese patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients age ≥ 18 years old.\n* Patients who will be treated with CMS for MR GNB infections.\n* Patients who are admitted to the ICUs.\n\nExclusion Criteria:\n\n* Known hypersensitivity to colistin.\n* Pregnant and lactating women.\n* Patients who are treated with colistin for \\< 24 hours.\n* Patients with myasthenia gravis or concomitant anesthetics or neuromuscular blocking drugs.'}, 'identificationModule': {'nctId': 'NCT06843668', 'briefTitle': 'Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Efficacy and Safety of Different Dosing Strategies of Colistin in Multidrug-Resistant Gram-Negative Bacilli Infections in Critically Ill Patients', 'orgStudyIdInfo': {'id': 'H-04-Q001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'The EMA (fixed dose) colistin group', 'description': 'The EMA colistin group will receive I.V colistin using fixed dose strategy.', 'interventionNames': ['Drug: EMA colistin dosing strategy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'US FDA (weight-based dose) colistin group', 'description': 'The weight-based colistin group will receive I.V. colistin using weight based dosing strategy.', 'interventionNames': ['Drug: US FDA colistin dosing strategy']}], 'interventions': [{'name': 'EMA colistin dosing strategy', 'type': 'DRUG', 'description': 'The EMA colistin group will receive I.V colistin based on creatinine clearance (mL/min) level , with fixed loading dose 9 MIU equivalent to 300 mg of colistin-based activity (CBA). The maintenance dose will be administered after 12 h following the loading dose over 1 h every 12h (twice daily).', 'armGroupLabels': ['The EMA (fixed dose) colistin group']}, {'name': 'US FDA colistin dosing strategy', 'type': 'DRUG', 'description': 'The weight-based colistin group will receive I.V. colistin based on the lower (ideal body weight or actual body weight) with a loading dose of (4) X (patient weight in kg). Loading dose might exceed 300 mg.', 'armGroupLabels': ['US FDA (weight-based dose) colistin group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Buraidah', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'Ayman A Alharbi, phd', 'role': 'CONTACT', 'email': 'Dr.aymn.a.h@gmail.com', 'phone': '00966540865609'}], 'facility': 'King Fahad Specialist Hospital', 'geoPoint': {'lat': 26.32599, 'lon': 43.97497}}], 'centralContacts': [{'name': 'Abdulmajeed S Alharbi, Master', 'role': 'CONTACT', 'email': 'majeed4440@hotmail.com', 'phone': '00966503984099'}, {'name': 'Mona M El-Tamalawy, Master', 'role': 'CONTACT', 'email': 'mona.m.eltamalawy@gmail.com', 'phone': '01220650700'}], 'overallOfficials': [{'name': 'Mohamed E Shams, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Mona Mohammed El-Tamalawy', 'investigatorAffiliation': 'Mansoura University'}}}}