NCT06392568

Brief Summary

Investigate the epidemiology, risk factors and impact on clinical practice of healthcare-associated infections with emergent highly drug-resistant (eHDR) pathogens, particularly carbapenem resistant enterobacteriaceae and glycopeptides-resistant enterococcus.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

March 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

2 months

First QC Date

March 30, 2024

Last Update Submit

April 27, 2024

Conditions

Cross InfectionCarbapenem Resistant Bacterial InfectionVancomycin-Resistant Enterococcal InfectionCritical Illness

Keywords

Critical careHealthcare Associated InfectionsDrug resistance

Outcome Measures

Primary Outcomes (2)

  • Highly resistant bacterial healthcare associated infections

    Incidence of eHRB healthcare associated infections in ICU

    2 months

  • Epidemiological features of Highly resistant bacterial healthcare associated infections healthcare associated infections in ICU

    Causative micro-organisms, sites and risk factors of eHRB healthcare associated infections in ICU

    2 months

Study Arms (2)

eHDR+

Patients with Emergent Highly Resistant Bacteria healthcare associated infection

Other: epidemiological records

eHDR-

Patients without Emergent Highly Resistant Bacteria healthcare associated infection

Interventions

epidemiological recordsOTHER

Healthcare associated infections due to emergent highly resistant bacteria, sites, risk factors, treatment and outcome

eHDR+

Eligibility Criteria

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

Adult ICU patients admitted during the study period

You may qualify if:

  • Adult ICU patients admitted during the study period

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abderrahmen Mami

Ariana, Tunis Governorate, 2080, Tunisia

RECRUITING

MeSH Terms

Conditions

Cross InfectionCritical Illness

Condition Hierarchy (Ancestors)

InfectionsIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Amira JAMOUSSI, Professor

    Abderrahmen Mami Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amira JAMOUSSI, Professor

CONTACT

+21698375250amira.jamoussi@fmt.utm.tn

Jalila BEN KHELIL, Professor

CONTACT

+21653689799jalila.benkhelil@fmt.utm.tn

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 30, 2024

Study Start

April 1, 2024

Primary Completion

May 31, 2024

Study Completion

May 31, 2024

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations

TU(1)