NCT03292224

Brief Summary

This study aims to :

  1. 1.Diagnosis of Systemic fungal infections in ICU patients.
  2. 2.Detection the most common fungal species in ICU.
  3. 3.Detection of in vitro antifungal sensitivity pattern

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2017

Typical duration 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

First Submitted

Initial submission to the registry

August 29, 2017

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

September 28, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2019

Completed
Last Updated

September 25, 2017

Status Verified

September 1, 2017

Enrollment Period

11 months

First QC Date

August 29, 2017

Last Update Submit

September 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    2weeks

Interventions

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

This study will include patients who will be admitted to intensive care unit in Assiut University Hospital regardless to age and sex.

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who received antifungal therapy within 3 days prior to sample collection.
  • Patients refused to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 19932132BACKGROUND
  • Leleu 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.

    PMID: 12297992BACKGROUND
  • Pappas 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.

    PMID: 26679628BACKGROUND
  • O'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.

    PMID: 4419464BACKGROUND

MeSH Terms

Conditions

Mycoses

Interventions

MicroscopyDiagnostic Imaging

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Mohamed zakaria, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

August 29, 2017

First Posted

September 25, 2017

Study Start

September 28, 2017

Primary Completion

September 1, 2018

Study Completion

October 15, 2019

Last Updated

September 25, 2017

Record last verified: 2017-09