Fungal InfectionNCT03292224
Systemic Fungal Infections in ICU Patients
An observational study of Fungal Infection, run by Assiut University.
Trial summary
This study aims to : 1. Diagnosis of Systemic fungal infections in ICU patients. 2. Detection the most common fungal species in ICU. 3. Detection of in vitro antifungal sensitivity pattern Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Fungal Infection
- What is being tested?
- - Microscopic examination and culture of collected specimens
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 28 Sep 2017to 15 Oct 2019
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will include patients who will be admitted to intensive care unit in Assiut University Hospital regardless to age and sex.
Who may be able to join
- Suppressed immunity such as: (patients with malignancy under chemotherapy, prolonged use of corticosteroids.………etc)
- Manifestations of chest infection e.g.cough, Haemoptysis, dyspnea and chest discomfort.
- Persistent fever resistant to antibiotic therapy.
- Urinary manifestations resistant to antibiotic therapy.
Who cannot join
- Patients who received antifungal therapy within 3 days prior to sample collection.
- Patients refused to participate in the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Systemic Fungal Infections in Intensive Care Unit Patients
This study aims to :
- Diagnosis of Systemic fungal infections in ICU patients.
- Detection the most common fungal species in ICU.
- Detection of in vitro antifungal sensitivity pattern
Read the detailed description
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.
- Conditions
- Fungal Infection
- Being tested
- - Microscopic examination and culture of collected specimens
- Medical subject headings
- Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
- Microscopic examination and culture of collected specimensDiagnostic test
Also called • Complete blood picture and Chest radiography.
- Unstained wet mount with 10%-20% KOH.
- Wet mounts stained with:
- Lactophenol cotton blue.
- India ink
- Gram stain Culturing on Sabouraud´s dextrose agar .
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2017
- Study start28 Sep 2017 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion15 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaimaa Selim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03292224
- Sponsor's protocol ID
- SFI in ICU Patients
- Status last verified
- Sep 2017
- First submitted
- 29 Aug 2017
- Last updated
- 25 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Jensen J, Guinea J, Torres-Narbona M, Munoz P, Pelaez T, Bouza E. Post-surgical invasive aspergillosis: an uncommon and under-appreciated entity. J Infect. 2010 Feb;60(2):162-7. doi: 10.1016/j.jinf.2009.11.005. Epub 2009 Nov 20.
PubMed 19932132Leleu G, Aegerter P, Guidet B; College des Utilisateurs de Base de Donnees en Reanimation. Systemic candidiasis in intensive care units: a multicenter, matched-cohort study. J Crit Care. 2002 Sep;17(3):168-75. doi: 10.1053/jcrc.2002.35815.
PubMed 12297992Pappas PG, Kauffman CA, Andes DR, Clancy CJ, Marr KA, Ostrosky-Zeichner L, Reboli AC, Schuster MG, Vazquez JA, Walsh TJ, Zaoutis TE, Sobel JD. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2016 Feb 15;62(4):e1-50. doi: 10.1093/cid/civ933. Epub 2015 Dec 16.
PubMed 26679628O'Keefe SJ, Sender PM, Clark CG, James WP. Proceedings: The dynamics of protein metabolism following operative trauma. Clin Sci Mol Med. 1974 Sep;47(3):15P. doi: 10.1042/cs047015pa. No abstract available.
PubMed 4419464
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Fungal Infections in Intensive Care Unit Patients
- ClinicalTrials.gov ID
- NCT03292224
- Acronym / sponsor ID
- SFI in ICU Patients
- Conditions
- Fungal Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 28 Sep 2017 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 15 Oct 2019 (estimated)
- First posted
- 25 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to :
- Diagnosis of Systemic fungal infections in ICU patients.
- Detection the most common fungal species in ICU.
- Detection of in vitro antifungal sensitivity pattern
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include patients who will be admitted to intensive care unit in Assiut University Hospital regardless to age and sex.
Key inclusion criteria (4 listed)
- Suppressed immunity such as: (patients with malignancy under chemotherapy, prolonged use of corticosteroids.………etc)
- Manifestations of chest infection e.g.cough, Haemoptysis, dyspnea and chest discomfort.
- Persistent fever resistant to antibiotic therapy.
- Urinary manifestations resistant to antibiotic therapy.
Key exclusion criteria (2 listed)
- Patients who received antifungal therapy within 3 days prior to sample collection.
- Patients refused to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| - Microscopic examination and culture of collected specimensAlso: • Complete blood picture and Chest radiography.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 . | Diagnostic test | – |
Primary outcome
Positive cultures of collected specimens from patients in ICU with suspected SFI.
Time frame: 2weeks
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2017.
- Background: PubMed 19932132Jensen J, Guinea J, Torres-Narbona M, Munoz P, Pelaez T, Bouza E. Post-surgical invasive aspergillosis: an uncommon and under-appreciated entity. J Infect. 2010 Feb;60(2):162-7. doi: 10.1016/j.jinf.2009.11.005. Epub 2009 Nov 20.
- Background: PubMed 12297992Leleu G, Aegerter P, Guidet B; College des Utilisateurs de Base de Donnees en Reanimation. Systemic candidiasis in intensive care units: a multicenter, matched-cohort study. J Crit Care. 2002 Sep;17(3):168-75. doi: 10.1053/jcrc.2002.35815.
- Background: PubMed 26679628Pappas PG, Kauffman CA, Andes DR, Clancy CJ, Marr KA, Ostrosky-Zeichner L, Reboli AC, Schuster MG, Vazquez JA, Walsh TJ, Zaoutis TE, Sobel JD. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clin Infect Dis. 2016 Feb 15;62(4):e1-50. doi: 10.1093/cid/civ933. Epub 2015 Dec 16.
- Background: PubMed 4419464O'Keefe SJ, Sender PM, Clark CG, James WP. Proceedings: The dynamics of protein metabolism following operative trauma. Clin Sci Mol Med. 1974 Sep;47(3):15P. doi: 10.1042/cs047015pa. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Infection, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed zakaria, Dr (01001983060, m-z-abokrisha@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive cultures of collected specimens from patients in ICU with suspected SFI. (time frame: 2weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03292224, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2017.