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OpenTrials
Completed

NCT Number: NCT01490684

Invasive Candidiasis in Saudi ICUs

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.

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Key information

Conditions

Invasive Candidiasis Bacterial Infections and Mycoses Candidiasis Candidiasis, Invasive Critical Illness Disease Attributes Infections Invasive Fungal Infections Mycoses Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

King Abdulaziz Medical City, Riyadh, Saudi Arabia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hasan Al-Dorzi

Other Gov

Collaborators

  • King Fahad Medical City

Registry information

Official study title

Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study

Acronym: ICIP-SA

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 13, 2011
Registry last updated
Aug 24, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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