跳至主要内容
临床试验/NCT04914013
NCT04914013Unknown不适用

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

Assiut University0 个研究点目标入组 50 人开始时间: 2021年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
detection of invasive fungal sinusitis after covid 19 infection.

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

detection of invasive fungal sinusitis after covid 19 infection.

时间窗: baseline

diagnosis of invasive fungal post COVID-19 infection

次要结局

  • Identify specific fungi that participate in IFS(1 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maiada K. Hashem

Lecturer

Assiut University

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