An observational study in Fungal Infection, sponsored by Assiut University. Status unknown. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by Assiut University · Observational
This study aims to :
Systemic fungal infections are a significant and growing public health problem ,Over the past few years, major advances in healthcare have led to an unwelcome increase in the number of life-threatening infections due to true pathogenic and opportunistic fungi ,These have a significant impact on morbidity, mortality, length of hospital stay, and healthcare costs in critically ill patients in intensive care unit ( ICU).
Health care workers encounter at risk patients in ICU in various settings : including diabetes mellitus, renal insufficiency, surgery (especially abdominal surgery), the use of broad-spectrum antibiotics, parenteral nutrition, hemodialysis, mechanical ventilation, the presence of central vascular catheters, and therapy with immunosuppressive agents,Prolonged treatment with corticosteroids before ICU admission, liver cirrhosis with prolonged ICU stay (.7 days), solid organ cancer, HIV infection and lung transplantation are also considered as risk factors ,It can also occur following trauma or invasion of wounds covered with contaminated dressings, e.g. in the ICU. One outbreak of gastric mucormycosis in ICU patients reported in Spain arose in association with the use of contaminated wooden tongue depressors in critically ill patients.
Candida and Aspergillus species are the most frequent causes of healthcare-associated fungal infections in these patients, Although Candida infections are the most frequent fungal infections in ICU patients, invasive aspergillosis is associated with higher morbidity and mortality rates even in the absence of traditional risk factors,Invasive candidiasis is a highly lethal infection associated with mortality rates between 40 and 60 %. The five most common Candida species are Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis, and Candida krusei.
Accurate diagnosis of invasive fungal infection is crucial so that appropriate antifungal agents can be started rapidly. However, early diagnosis is not always easy. Microscopic examination is rapid and can be helpful but a negative result does not exclude infection. Blood cultures are positive in only 50-70 % of cases of Candida BSI, Furthermore, it can take several days before Candida is identified at the species level and antifungal susceptibility data are available but remain the gold stander in diagnosis.
260 studies on the registry are indexed under Mycoses; 37 are open to participants now.
This study's planned enrollment of 100 is below the median of 153 across 85 observational studies indexed under Mycoses.
Browse Mycoses studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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This study will include patients who will be admitted to intensive care unit in Assiut University Hospital regardless to age and sex.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Unstained wet mount with 10%-20% KOH. 2. Wet mounts stained with: * Lactophenol cotton blue. * India ink * Gram stain Culturing on Sabouraud´s dextrose agar .
Also known as: • Complete blood picture and Chest radiography.
Positive cultures of collected specimens from patients in ICU with suspected SFI.
samples (blood ,urine and sputum) will be taken under complete aseptic precautions in sterile containers and carried immediately for culturing on sabouraud dextrose agar .Positive cultures help in early diagnosis of systemic fungal infections
Time frame: 2weeks
No study locations are listed for this record.
Start is estimated for Sep 2017; primary completion for Sep 2018, 11 months later.
Of 28 observational studies under Mycoses, half reached primary completion within 39 months of starting (the median), counting those still running; a quarter within 17. This study's planned 11 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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