NCT04111224

Brief Summary

This study will assess the role of pentraxin3 (PTX3) in the early diagnosis of ventilator-associated pneumonia (VAP) and the detection of antibiotic sensitivity for different organisms isolated from tracheal aspirate.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

January 14, 2020

Status Verified

January 1, 2020

Enrollment Period

Same day

First QC Date

September 29, 2019

Last Update Submit

January 13, 2020

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Assess the role of pentraxin3 (PTX3) in the early diagnosis of ventilator-associated pneumonia (VAP).

    Pentraxin3 (PTX3) is an acute-phase inflammatory mediator whose levels increase rapidly in inflammatory and infectious conditions. Increased PTX3 levels are correlated with the severity of lung injury and infection.

    Baseline

Interventions

pentraxin 3 markerDIAGNOSTIC_TEST

Assess the role of pentraxin3 (PTX3) in the early diagnosis of ventilator-associated pneumonia (VAP).

Eligibility Criteria

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

45 patients will be included in the study, the first sample will be taken in the first day of the endotracheal intubation as a control sample then the second sample will be the part the first sample patients who will develop VAP (\>48 h of endotracheal intubation).

You may qualify if:

  • study will be conducted on adult patients \>18 years who will have VAP in intensive care unit (ICU) of chest department of Assiut university hospital.

You may not qualify if:

  • Patients with age \<18 years .
  • Patients with any hospital acquired infections other than VAP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated PneumoniaCross InfectionInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesIatrogenic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Reham M Abdelsater, resident dr

    Assiut University

    PRINCIPAL INVESTIGATOR

  • Monazzma A Fadel, professor

    Assiut University

    STUDY DIRECTOR

  • Amal M Hosni, lecturer

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Reham M Abdelsater, resident dr

CONTACT

00201024410404Rehamabdelsater@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident dr

Study Record Dates

First Submitted

September 29, 2019

First Posted

October 1, 2019

Study Start

February 1, 2020

Primary Completion

February 1, 2020

Study Completion

February 1, 2021

Last Updated

January 14, 2020

Record last verified: 2020-01