NCT04809480

Brief Summary

Data for acute invasive rhinosinusitis was obtained from the Otorhinolaryngology departments at our tertiary hospital at the period from January 2017 to December 2020. Then the risk factors of comorbid diseases and fungal types between post-Covid-19 and non-Covid-19 groups regarding the incidence of invasive rhinosinusitis are compared.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

4 years

First QC Date

March 19, 2021

Last Update Submit

March 19, 2021

Conditions

Keywords

fungal sinusitisrhinosinusitis

Outcome Measures

Primary Outcomes (1)

  • Fungus detection

    Culture and microscopic examination by the light microscope to examine the different types of the fungi using hematoxylin \& eosin stain and Periodic acid-Schiff stain which is positive in fungi

    2 weeks

Study Arms (2)

Non-COVID19 patients

All acute invasive fungal rhinosinusitis patients managed in our hospital from January 2017 up to February 2020

Diagnostic Test: Fungal rhinosinusitis

COVID19 patients

All acute invasive fungal rhinosinusitis patients managed in our hospital from February 2020 up to December 2020 with positive COVID19 PCR test

Diagnostic Test: Fungal rhinosinusitis

Interventions

Fungal rhinosinusitisDIAGNOSTIC_TEST

Pathology examination

COVID19 patientsNon-COVID19 patients

Eligibility Criteria

Age15 Years - 90 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients of any age and sex medically managed in AlAzhar Hospitals in Egypt for invasive rhinosinusoitis

You may qualify if:

  • Patients of any age and sex. invasive rhinosinusoitis diagnosis based on clinical , endoscopic diagnosis
  • Positive findings for acute sinusitis on sinus computed tomography (CT) scan in addition to fungal determination by histopathological examination of specimen of affected tissues for detection of the type of fungi.
  • Positive PCR was confirmed from the patient's files at the isolation hospitals for COVID 19 group.

You may not qualify if:

  • Patients who completed management outside our hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

COVID-19Rhinosinusitis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRhinitisSinusitisParanasal Sinus DiseasesNose DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
laboratory manager

Study Record Dates

First Submitted

March 19, 2021

First Posted

March 22, 2021

Study Start

January 1, 2017

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 22, 2021

Record last verified: 2021-03