Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-28 @ 2:01 AM
Study NCT ID:
NCT05911035
Status:
COMPLETED
Last Update Posted:
2023-06-20
First Post:
2023-06-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-COVID-19 Mucormycosis in Critical Care
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009091', 'term': 'Mucormycosis'}, {'id': 'D015817', 'term': 'Eye Infections'}, {'id': 'D012852', 'term': 'Sinusitis'}], 'ancestors': [{'id': 'D020096', 'term': 'Zygomycosis'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-16', 'studyFirstSubmitDate': '2023-06-12', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '48 weeks', 'description': 'mortality rate of patients with mucormycosis in the critical care'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': '48weeks', 'description': 'complications arise from the treatment with Amphotericin B'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mucormycosis', 'Post COVID-19', 'Cutaneous infection', 'Ocular infection', 'Sinus infection'], 'conditions': ['Mucormycosis; Rhinocerebral (Etiology)', 'Post COVID-19 Condition, Unspecified']}, 'descriptionModule': {'briefSummary': 'Background: Mucormycosis is a life-threatening opportunistic fungal infection. Despite mucormycosis having existed for decades, it has gained notice of its widespread in many parts of the world during the second wave of the coronavirus disease 2019 (COVID-19) pandemic. The study aimed to determine the in-hospital outcomes of post-COVID-19 mucormycosis during the intensive care unit (ICU) stay in Egypt.\n\nMethods: This prospective cohort study included all patients admitted to the Medical ICU of the University Hospital who developed Mucormycosis with a history of previous COVID-19 infection. Clearance of previous COVID-19 was confirmed using PCR and high-resolution computed tomography (CT) on the chest before admission.', 'detailedDescription': 'Study design, settings, and participants This prospective cohort study was conducted in the medical ICU of the Zagazig University Hospital, Egypt, comprising 150 Post COVID-19 patients who developed Mucormycosis infection.\n\nThe investigators take the approval of the Institutional Review Board (IRB) ethical committee under code (ZU-IRB#9491/26-4-2022). The study was conducted under the guidance of the Declaration of Helsinki. Written informed consent was taken from all patients or first-degree relatives in case of altered sensorium.\n\nThe inclusion criteria were all patients aged 18 or older, of both genders, and confirmed previous COVID-19 with Mucormycosis infection were included in this study. We excluded patients with other fungal infections post-COVID-19 or Mucormycosis infection without previous COVID-19.\n\nProcess For all cases, the first step was to perform a polymerase chain reaction (PCR) to exclude current COVID-19 on admission and high-resolution computed tomography (CT) on the chest.\n\nThe complete medical history was also recorded of all patients, including demographic details (age, gender, residence, and smoking) and the risk factors, such as diabetes mellitus (DM), hypertension, chronic kidney disease (CKD), and other comorbidities).\n\nRoutine laboratory investigations were conducted, including complete blood count (CBC), liver functions, kidney functions, C-reactive protein (CRP), and arterial blood gases (ABG) daily. Also, Glycated hemoglobin (HbA1c), D-Dimer, Procalcitonin (PCT), Ferritin at admission, sodium (Na), and potassium (K) every four hours. In addition to specific laboratory investigations like a cluster of differentiation (CD4/CD8) ratio on admission and interleukin 6 (IL6) on admission and after three days. The patient also had further investigations, such as electrocardiography (ECG).\n\nRegarding imaging, routine studies like abdominal ultrasonography (US) and echocardiography or specific for mucormycosis like CT or magnetic resonance imaging (MRI) for brain and nasal sinuses were conducted. For patients who needed surgical debridement, preoperative viral markers (HCV antibody, HBs antigen, HIV antibody) were drawn, and intraoperative biopsies were taken for histopathological examination. Patients initially received conventional Amphotericin B, while in case of therapy complications, the treatment is converted to liposomal Amphotericin B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with a history of previously cleared COVID-19 infection who were admitted to critical care with newly developed mucormycosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* confirmed previous COVID-19 infection with new mucormycosis infection\n\nExclusion Criteria:\n\n* other fungal infections post-COVID-19 or mucormycosis infections without previous COVID-19'}, 'identificationModule': {'nctId': 'NCT05911035', 'briefTitle': 'Post-COVID-19 Mucormycosis in Critical Care', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Zagazig University'}, 'officialTitle': 'Post COVID-19 Acute Mucormycosis in Critical Care Settings in Egypt: A Single-Center Experience', 'orgStudyIdInfo': {'id': 'ZU-IRB#9491/26-4-2022'}}, 'contactsLocationsModule': {'locations': [{'zip': '44519', 'city': 'Zagazig', 'state': 'Sharqia Province', 'country': 'Egypt', 'facility': 'Faculty of Human Medicine, Zagazig University', 'geoPoint': {'lat': 30.58768, 'lon': 31.502}}], 'overallOfficials': [{'name': 'Ayman Sadek, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Zagazig University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zagazig University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Ayman Magd Eldin Mohammad Sadek', 'investigatorAffiliation': 'Zagazig University'}}}}