Invasive CandidiasisICIP-SANCT01490684
Invasive Candidiasis in Saudi ICUs
An observational study of Invasive Candidiasis, run by Hasan Al-Dorzi at 2 sites in Saudi Arabia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Candidiasis
- How many people
- 162 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Aug 2012to May 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
King Abdulaziz Medical City
Riyadh
King Fahad Medical City
Riyadh
About this study
Official title: Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study
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.
- Conditions
- Invasive Candidiasis
- Keywords
- candidiasis, critically ill, outcomes
- Medical subject headings
- Candidiasis, Invasive, Candidiasis, Critical Illness
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
If patients are still alive in the ICU at 180 days after entring the sudy, they will be considered ICU survivors.
Measured: 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
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.
Measured: date of extubtation minus date of intubation
Length of Stay in the 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.
Measured: date of discharge from ICU minus date of admission to ICU
Length of Stay in the 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.
Measured: date of discharge from hospital minus date of admission to hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2011 (estimated)
- Study startAug 2012
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Invasive CandidiasisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasan Al-Dorzi
- Sponsor type
- Other government
- Collaborators
- King Fahad Medical City
- Responsible party
- Sponsor-investigator, Hasan Al-Dorzi, King Abdulaziz Medical City
- Investigators
- Hasan Al-Dorzi, MD, Principal investigator, King Abdulaziz Medical City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01490684
- Sponsor's protocol ID
- KAMC
- Acronym
- ICIP-SA
- Status last verified
- Nov 2017
- First submitted
- 2 Dec 2011
- Last updated
- 24 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29628014
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Invasive Candidiasis in Critically Ill Patients in Saudi Arabia: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT01490684
- Acronym / sponsor ID
- ICIP-SA / KAMC
- Conditions
- Invasive Candidiasis
- Keywords
- candidiasis, critically ill, outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Hasan Al-DorziOther government
- Collaborators
- King Fahad Medical City
- Study start
- Aug 2012
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 13 Dec 2011 (estimated)
- Results
- Posted 24 Aug 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
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.
Duration of Mechanical Ventilation
Time frame: date of extubtation minus date of intubation
Length of Stay in the ICU
Time frame: date of discharge from ICU minus date of admission to ICU
Length of Stay in the Hospital
Time frame: date of discharge from hospital minus date of admission to hospital
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29628014Al-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.
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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.
Hasan Al-Dorzi, MD principal investigator
King Abdulaziz Medical City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Candidiasis, run by Hasan Al-Dorzi at 2 sites in Saudi Arabia.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 24 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 24 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 NCT01490684, which also lists 1 linked publication.
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 24 Aug 2018.