NCT05911035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 12, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 20, 2023

Completed
Last Updated

June 20, 2023

Status Verified

June 1, 2023

Enrollment Period

1 year

First QC Date

June 12, 2023

Last Update Submit

June 16, 2023

Conditions

Mucormycosis; Rhinocerebral (Etiology)Post COVID-19 Condition, Unspecified

Keywords

MucormycosisPost COVID-19Cutaneous infectionOcular infectionSinus infection

Outcome Measures

Primary Outcomes (1)

  • Mortality

    mortality rate of patients with mucormycosis in the critical care

    48 weeks

Secondary Outcomes (1)

  • Complications

    48weeks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with a history of previously cleared COVID-19 infection who were admitted to critical care with newly developed mucormycosis

You may qualify if:

  • confirmed previous COVID-19 infection with new mucormycosis infection

You may not qualify if:

  • other fungal infections post-COVID-19 or mucormycosis infections without previous COVID-19

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Human Medicine, Zagazig University

Zagazig, Sharqia Province, 44519, Egypt

Location

MeSH Terms

Conditions

MucormycosisEye InfectionsSinusitis

Condition Hierarchy (Ancestors)

ZygomycosisMycosesBacterial Infections and MycosesInfectionsEye DiseasesRespiratory Tract InfectionsParanasal Sinus DiseasesNose DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Officials

  • Ayman Sadek, MD

    Zagazig University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Internal Medicine

Study Record Dates

First Submitted

June 12, 2023

First Posted

June 20, 2023

Study Start

May 1, 2021

Primary Completion

May 1, 2022

Study Completion

May 1, 2023

Last Updated

June 20, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)