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Invasive Candidiasis in Saudi ICUs (ICIP-SA)

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ClinicalTrials.gov Identifier: NCT01490684
Recruitment Status : Completed
First Posted : December 13, 2011
Results First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Collaborator:
King Fahad Medical City
Information provided by (Responsible Party):
Hasan Al-Dorzi, King Abdulaziz Medical City

Brief Summary:
Epidemiology and clinical outcomes of invasive candidiasis in critically ill patients in Saudi Arabia is not well studied. This observational study objectives include to determine the epidemiology, risk factors and outcomes of invasive Candida infection in critically ill patients in Saudi Arabia.

Condition or disease
Invasive Candidiasis

Study Type : Observational
Actual Enrollment : 162 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study
Study Start Date : August 2012
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Yeast Infections




Primary Outcome Measures :
  1. Hospital Mortality [ Time Frame: Patients will be followed while in the ICU and the vital status at the time of discharge from the ICU will be noted. The expected stay in the ICU is 10 days on average. ]
    For patients staying in the ICU for long periods, hospital mortality will be censored at 180 days after entry into the study.That is patient staying alive in the hospital more than 180 days will be considered alive.


Secondary Outcome Measures :
  1. ICU Mortality [ Time Frame: patients will be followed until discharge from the hospital and vital status at discharge from the hospital will be noted (expected hospital stay is 5 weeks). Hopsital mortality will be censored at 180 days after entry into the study. ]
    If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.

  2. Duration of Mechanical Ventilation [ Time Frame: date of extubtation minus date of intubation ]
    If multiple intubations in the same admission, then the durations of mechanical ventilation will be added.This will be assessed for up to 180 days of stay in the ICU.

  3. Length of Stay in the ICU [ Time Frame: date of discharge from ICU minus date of admission to ICU ]
    Patients will be followed for up to 180 days.Patinets alive in the ICU beyond 180 days of stay will have an ICU length of stay of 180 days.

  4. Length of Stay in the Hospital [ Time Frame: date of discharge from hospital minus date of admission to hospital ]
    Patients will be followed for up to 180 days.Patinets alive in the hospital beyond 180 days of stay will have a hospital length of stay of 180 days.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients (> 18 years) admitted to the ICUs of these centers will be evaluated for the occurrence of Candida infection and followed to discharge or death in ICU. The duration of the study will be 12 months. Also patients who had invasive candidiasis within 72 hours of ICU admission will be included.
Criteria

Inclusion Criteria:

  • adult patients (> 18 years)
  • develop invasive candidiasis as per prespecified definitions during ICU stay
  • In addition, patients who had invasive candidiasis within 72 hours of ICU admission will be included

Exclusion Criteria:

  • Diagnosis of invasive candidiasis (definite or probable) more than 72 hours before ICU admission.
  • Diagnosis of invasive candidiasis (definite or probable) within 72 hours of ICU admission, but the admission to ICU for an unrelated reason.
  • Readmission to the ICU during the same hospitalization with invasive candidiasis occurring during one of the previous admissions.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490684


Locations
Saudi Arabia
King Abdulaziz Medical City
Riyadh, Saudi Arabia
King Fahad Medical City
Riyadh, Saudi Arabia
Sponsors and Collaborators
Hasan Al-Dorzi
King Fahad Medical City
Investigators
Principal Investigator: Hasan Al-Dorzi, MD King Abdulaziz Medical City

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hasan Al-Dorzi, Consultant, Intensive Care Department, King Abdulaziz Medical City
ClinicalTrials.gov Identifier: NCT01490684     History of Changes
Other Study ID Numbers: KAMC
First Posted: December 13, 2011    Key Record Dates
Results First Posted: August 24, 2018
Last Update Posted: August 24, 2018
Last Verified: November 2017

Keywords provided by Hasan Al-Dorzi, King Abdulaziz Medical City:
candidiasis
critically ill
outcomes

Additional relevant MeSH terms:
Candidiasis
Candidiasis, Invasive
Mycoses
Invasive Fungal Infections