Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05911035
Status:
COMPLETED
Last Update Posted:
2023-06-20
First Post:
2023-06-12
Brief Title:
Post-COVID-19 Mucormycosis in Critical Care
Sponsor:
Zagazig University
Organization:
Zagazig University
Study Overview
Official Title:
Post COVID-19 Acute Mucormycosis in Critical Care Settings in Egypt A Single-Center Experience
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Methods 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
Methods 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
Detailed Description:
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
The investigators take the approval of the Institutional Review Board IRB ethical committee under code ZU-IRB949126-4-2022 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
The 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
Process 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
The 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
Routine 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 CD4CD8 ratio on admission and interleukin 6 IL6 on admission and after three days The patient also had further investigations such as electrocardiography ECG
Regarding 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
The investigators take the approval of the Institutional Review Board IRB ethical committee under code ZU-IRB949126-4-2022 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
The 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
Process 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
The 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
Routine 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 CD4CD8 ratio on admission and interleukin 6 IL6 on admission and after three days The patient also had further investigations such as electrocardiography ECG
Regarding 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None