Fugal Infection in COVID-19 Patients

Covid19 Clinical Trial

Official title:

Invasive Fungal Sinusitis Among Post COVID-19 Survivors in Upper Egypt

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04914013
• Other study ID #: Fungi in COVID-19
• Status: Not yet recruiting
• Start date: June 2021
• Est. completion date: September 2021

Study information

• Verified date: June 2021
• Source: Assiut University
• Contact: Maiada Hashem
• Phone: 01006559662
• Email: maiada.hashem[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

Description:

Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2); the causative organism of Coronavirus disease 2019 (Covid-19); infects primarily the lungs leading to more than 100 million COVID-19 cases around the world, resulting in almost three million deaths. Covid-19 spectrum of symptoms expanded from upper respiratory tract infection to extensive viral pneumonia and respiratory failure. Covid-19 patients are highly susceptible to superimposed secondary infection especially fungal infections.

Acute invasive fungal sinusitis (AIFS) is one of the most aggressive forms of sinusitis that is commonly present in immunocompromised patients and frequently leads to significant mortality and morbidity. Mucormycosis a life threatening AIFS characterized by hyphal invasion and massive destruction of maxillofacial structures. Histological characters include mycotic infiltration of vessels with propensity to tissue infarction. In addition to other fungi such as Acinetobacter, Klebsiella, Enterobacter, Aspergillus and Candida that frequently lead to secondary fungal infection in Covid-19 patients.

The co-existence of Covid-19 and AIFS is due to immune dysregulation in Covid-19 patients as both CD4+ and CD8+ T lymphocytes are suppressed thus impair patients' innate immunity. In addition to the extensive use of steroids, broad spectrum antibiotics and monoclonal antibodies may contribute in fungal infection. Covid-19 patients with pre-existing conditions such as untreated HIV, organ transplantation, un controlled diabetes and malignancies are more susceptible to AIFS on the contrary Covid-19 patients with underlying chronic disease such as hypertension, chronic kidney and chronic heart disease usually are not associated with more risk of AIFS.

Taking in consideration raised incidence of morbidity and mortality associated with AIFS and on the other hand limited studies available especially in middle east region raised the importance of studying the incidence and the behaviour of AIFS in Covid-19 patients. This study aims to To assess the occurrence of AIFS superinfections in patients with Covid-19.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 2021
• Est. primary completion date: August 2021
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - Patients who received antifungal therapy within three days prior to sample collection.

• Patients refused to participate in the study.

Related Conditions & MeSH terms

• Covid19

Intervention

Other:
• no intervention
no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Alanio A, Dellière S, Fodil S, Bretagne S, Mégarbane 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. — View Citation

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. — View Citation

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 Apr 8:1-6. doi: 10.1017/S0022215121000992. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection of invasive fungal sinusitis after covid 19 infection.	diagnosis of invasive fungal post COVID-19 infection	baseline
Secondary	Identify specific fungi that participate in IFS	specify by culture and sensitivity fungi that participate in invasive fungal sinusitis after covid 19 infection	1 month