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Post-COVID-19 Mucormycosis in Critical Care

Sponsor
Zagazig University (Other)
Overall Status
Completed
CT.gov ID
NCT05911035
Collaborator
(none)
150
Enrollment
1
Location
24
Actual Duration (Months)
6.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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-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.

    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 (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).

    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 Design

    Study Type:
    Observational
    Actual Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Post COVID-19 Acute Mucormycosis in Critical Care Settings in Egypt: A Single-Center Experience
    Actual Study Start Date :
    May 1, 2021
    Actual Primary Completion Date :
    May 1, 2022
    Actual Study Completion Date :
    May 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Mortality [48 weeks]

      mortality rate of patients with mucormycosis in the critical care

    Secondary Outcome Measures

    1. Complications [48weeks]

      complications arise from the treatment with Amphotericin B

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • confirmed previous COVID-19 infection with new mucormycosis infection
    Exclusion Criteria:
    • other fungal infections post-COVID-19 or mucormycosis infections without previous COVID-19

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Human Medicine, Zagazig University Zagazig Sharkia Egypt 44519

    Sponsors and Collaborators

    • Zagazig University

    Investigators

    • Principal Investigator: Ayman Sadek, MD, Zagazig University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ayman Magd Eldin Mohammad Sadek, Associate Professor of Internal Medicine, Zagazig University
    ClinicalTrials.gov Identifier:
    NCT05911035
    Other Study ID Numbers:
    • ZU-IRB#9491/26-4-2022
    First Posted:
    Jun 20, 2023
    Last Update Posted:
    Jun 20, 2023
    Last Verified:
    Jun 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ayman Magd Eldin Mohammad Sadek, Associate Professor of Internal Medicine, Zagazig University
    Mucormycosis
    Post COVID-19
    Cutaneous infection
    Ocular infection
    Sinus infection
    Additional relevant MeSH terms:
    COVID-19
    Mucormycosis
    Zygomycosis

    Study Results

    No Results Posted as of Jun 20, 2023