NCT01490684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2012

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

December 2, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 13, 2011

Completed
8 months until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

August 24, 2018

Completed
Last Updated

August 24, 2018

Status Verified

November 1, 2017

Enrollment Period

3.8 years

First QC Date

December 2, 2011

Results QC Date

November 30, 2017

Last Update Submit

November 30, 2017

Conditions

Invasive Candidiasis

Keywords

candidiasiscritically illoutcomes

Outcome Measures

Primary Outcomes (1)

  • Hospital Mortality

    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.

    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.

Secondary Outcomes (4)

  • ICU Mortality

    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.

  • Duration of Mechanical Ventilation

    date of extubtation minus date of intubation

  • Length of Stay in the ICU

    date of discharge from ICU minus date of admission to ICU

  • Length of Stay in the Hospital

    date of discharge from hospital minus date of admission to hospital

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

King Abdulaziz Medical City

Riyadh, Saudi Arabia

Location

King Fahad Medical City

Riyadh, Saudi Arabia

Location

Related Publications (1)

  • Al-Dorzi HM, Sakkijha H, Khan R, Aldabbagh T, Toledo A, Ntinika P, Al Johani SM, Arabi YM. Invasive Candidiasis in Critically Ill Patients: A Prospective Cohort Study in Two Tertiary Care Centers. J Intensive Care Med. 2020 Jun;35(6):542-553. doi: 10.1177/0885066618767835. Epub 2018 Apr 8.

    PMID: 29628014DERIVED

MeSH Terms

Conditions

Candidiasis, InvasiveCandidiasisCritical Illness

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfectionsInvasive Fungal InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Hasan Al-Dorzi
Organization
King Abdulaziz Medical City
aldorzih@yahoo.com
966535888632

Study Officials

  • Hasan Al-Dorzi, MD

    King Abdulaziz Medical City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Consultant, Intensive Care Department

Study Record Dates

First Submitted

December 2, 2011

First Posted

December 13, 2011

Study Start

August 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

August 24, 2018

Results First Posted

August 24, 2018

Record last verified: 2017-11

Locations

SA(2)