NCT05547646

Brief Summary

We aimed to determine the prevalence of HAI in medical Tunisian ICUs. Secondary endpoints were to identify the predominant infecting microorganisms and evaluate independent risk factors of HAIs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

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

September 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

September 21, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

September 27, 2022

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 28, 2022

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

1 day

First QC Date

September 1, 2022

Last Update Submit

August 18, 2023

Conditions

Cross InfectionPrevalenceEpidemiologyCritical Care

Keywords

Iatrogenic DiseaseCross InfectionIntensive Care UnitsPrevalenceRisk FactorsCritical Care

Outcome Measures

Primary Outcomes (1)

  • Determine the prevalence of healthcare-associated infection in medical Tunisian ICUs

    The number of infected patients divided by the total number of patients at the day of the study

    September 27th, 2022

Secondary Outcomes (1)

  • Identify independent risk factors of HAIs.

    September 27th, 2022

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

One-day point-prevalence study (September 27th, 2022) All medical ICUs across Tunisia are invited to participate, excluding cardiologic and paediatric care units. All patients occupying an ICU bed over a 48-hour period are eligible.

You may qualify if:

  • All patients occupying an ICU bed over a 48-hour period
  • Age \>=18 years

You may not qualify if:

  • no criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical ICU

Tunis, Ariana Governorate, 2080, Tunisia

Location

MeSH Terms

Conditions

Cross InfectionIatrogenic Disease

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amira JAMOUSSI, pROFESSOR

    Ministery of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Associate Professor

Study Record Dates

First Submitted

September 1, 2022

First Posted

September 21, 2022

Study Start

September 27, 2022

Primary Completion

September 28, 2022

Study Completion

September 28, 2022

Last Updated

August 21, 2023

Record last verified: 2023-08

Locations

TU(1)