NCT04914013

Brief Summary

Screening early detection of invasive fungal sinusitis in COVID-19 positive patients

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Shorter than P25 for all trials

Status
unknown

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

June 1, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

June 4, 2021

Status Verified

June 1, 2021

Enrollment Period

2 months

First QC Date

June 2, 2021

Last Update Submit

June 2, 2021

Conditions

Keywords

COVID-19, invasive fungal infection

Outcome Measures

Primary Outcomes (1)

  • detection of invasive fungal sinusitis after covid 19 infection.

    diagnosis of invasive fungal post COVID-19 infection

    baseline

Secondary Outcomes (1)

  • Identify specific fungi that participate in IFS

    1 month

Interventions

no intervention

Eligibility Criteria

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

Patients who were diagnosed with invasive fungal sinusitis, and are survivors of Covid19 infection, all cases diagnosed on the basis of the interim guidance of the World Health Organization (WHO) for diagnosis of SARS-CoV-2. Patients were recruited from:1- Otorhinolaryngology Department, Assuit university hospital. 2- Intermediate care unit of Internal Medicine department. 3-Respiratory Intensive care unite and chest department.

You may qualify if:

  • Patients who were diagnosed with invasive fungal sinusitis, and are survivors of Covid19 infection, all cases diagnosed on the basis of the interim guidance of the World Health Organization (WHO) for diagnosis of SARS-CoV-2.

You may not qualify if:

  • \- Patients who received antifungal therapy within three days prior to sample collection.
  • Patients refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Fekkar A, Lampros A, Mayaux J, Poignon C, Demeret S, Constantin JM, Marcelin AG, Monsel A, Luyt CE, Blaize M. Occurrence of Invasive Pulmonary Fungal Infections in Patients with Severe COVID-19 Admitted to the ICU. Am J Respir Crit Care Med. 2021 Feb 1;203(3):307-317. doi: 10.1164/rccm.202009-3400OC.

    PMID: 33480831BACKGROUND
  • Sharma S, Grover M, Bhargava S, Samdani S, Kataria T. Post coronavirus disease mucormycosis: a deadly addition to the pandemic spectrum. J Laryngol Otol. 2021 May;135(5):442-447. doi: 10.1017/S0022215121000992. Epub 2021 Apr 8.

    PMID: 33827722BACKGROUND
  • Alanio A, Delliere S, Fodil S, Bretagne S, Megarbane B. Prevalence of putative invasive pulmonary aspergillosis in critically ill patients with COVID-19. Lancet Respir Med. 2020 Jun;8(6):e48-e49. doi: 10.1016/S2213-2600(20)30237-X. Epub 2020 May 20. No abstract available.

    PMID: 32445626BACKGROUND

MeSH Terms

Conditions

COVID-19Invasive Fungal Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesMycosesBacterial Infections and Mycoses

Central Study Contacts

Aliae Mohamed-Hussien

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 4, 2021

Study Start

June 1, 2021

Primary Completion

August 1, 2021

Study Completion

September 1, 2021

Last Updated

June 4, 2021

Record last verified: 2021-06