Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT05944458
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 250}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-07-06', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "difference in incidence of LIT between patients who received NAC and patients who didn't.", 'timeFrame': 'From starting linezolid untill 14 days after linezolid discontinuation or ICU discharge whichever comes first.', 'description': 'Defined as platelets \\< 150000 OR decrease \\> or = 50% of baseline platelets.'}], 'secondaryOutcomes': [{'measure': 'Blood products transfusion, bleeding, length of ICU stay, and in-ICU mortality incidence between 2 groups.', 'timeFrame': 'From start linezolid until ICU discharge'}, {'measure': 'Difference in time to platelet recovery between the 2 groups', 'timeFrame': 'From thrombocytopenia onset to recovery, assesed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first', 'description': 'after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts \\> 70% of baseline values'}, {'measure': 'Difference in time to thrombocytopenia onset between the 2 groups', 'timeFrame': 'From linezolid start date until date of first thrombocytopenia event, assessed up to 14 days after linezolid discontinuation or ICU discharge whichever comes first'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Linezolid', 'Antioxidant', 'Thrombocytopenia', 'Critical Illness', 'ICU']}, 'descriptionModule': {'briefSummary': '* Study the effect of acetylcysteine on decreasing the incidence of LIT in critically ill patients.\n* Study the impact of acetylcysteine on the time to onset of LIT and the time to recovery of platelets.', 'detailedDescription': "Primary outcome: difference in incidence of LIT between patients who received NAC and patients who didn't.\n\n* Primary outcome definition: Defined as platelets \\< 150000 OR decrease \\> 50% of baseline platelets.\n* Secondary outcome: difference in Time to onset of LIT and time to recovery between the 2 groups. Blood products transfusion, bleeding, length of stay, and in-hospital mortality incidence between 2 groups.\n* Secondary outcome definitions: after having thrombocytopenia, regardless of discontinuation of linezolid, recovery is defined as the restoration and maintenance of platelet counts \\> 70% of baseline values."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (age ≥ 18 years)\n* Admitted to the Intensive Care Unit (ICU)\n* Candidates for intravenous linezolid therapy for ≥ 48 hours\n\nExclusion Criteria:\n\n* Baseline platelet count \\< 50 × 10⁹/L\n* Diagnosis of malignancy\n* Receipt of any chemotherapeutic agent within the past 6 months\n* Positive COVID-19 RT-PCR test at admission\n* Diagnosis of immune thrombocytopenia\n* Presence of splenomegaly\n* Presence of liver cirrhosis\n* Presence of hepatitis C\n* Refusal to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05944458', 'briefTitle': 'Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients', 'organization': {'class': 'OTHER', 'fullName': 'Helwan University'}, 'officialTitle': 'Efficacy of Intravenous N-Acetylcysteine in Preventing Linezolid-Induced Thrombocytopenia in Critically Ill Patients: A Double-Blind Randomized Placebo-Controlled Trial', 'orgStudyIdInfo': {'id': '11041990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'N-acetylcysteine group', 'description': 'Generic name: N-acetylcysteine.\n\n* Trade name: Fluimucil.\n* Company: Zambon.\n* Dosage form: ampoules for intravenous administration.\n* Dose: 600mg taken every 12 hours daily with a fixed dose as there is no need for renal or hepatic adjustment, starting with the inception of linezolid therapy.\n* Duration: for 14 days post linezolid discontinuation or until ICU discharge, whichever came first.', 'interventionNames': ['Drug: N acetyl cysteine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard of care', 'description': 'They will receive standard of care (Platelets monitoring daily, linezolid discontinuation if platelet count less than 50000 or clinically appropriate and platelet transfusion according to the institutional protocol) plus placebo (20 ml normal saline twice daily)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'N acetyl cysteine', 'type': 'DRUG', 'otherNames': ['Fluimucil', 'NAC'], 'description': 'Fluimucil 600 mg iv to be taken twice daily as infusion', 'armGroupLabels': ['N-acetylcysteine group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '20 ml normal saline iv every 12 hours', 'armGroupLabels': ['Standard of care']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Cairo Governorate', 'country': 'Egypt', 'facility': '15 May hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed Abdeltawab, Pharm D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical pharmacy, 15 May hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Helwan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical pharmacist', 'investigatorFullName': 'Mohamed Abdeltawab', 'investigatorAffiliation': 'Helwan University'}}}}