Lung Ultrasound in Procalcitonin- Guided Antibiotic Discontinuation in Ventilator Associated Pneumonia

September 26, 2021 updated by: Mona Ammar, Ain Shams University
Ventilator Associated pneumonia (VAP) is associated with longer ICU length of stay, prolonged mechanical ventilation, and increased use of antimicrobials, health-care cost and mortality . Acute respiratory infections (ARIs) comprise a large and heterogeneous group of infections, including bacterial infections, viral infections, and infections of other etiologies. Early initiation of adequate antibiotic therapy is the cornerstone in the treatment. However, overuse of antibiotics and prolonged duration of antibiotic therapy in patients with bacterial ARIs in the hospital and intensive care setting is associated with increased resistance for common bacteria, high costs, and adverse drug reactions.

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

62

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cairo, Egypt
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients having ventilator associated pneumonia (VAP) with positive sputum culture. VAP was considered if the onset occurred following intubation of the trachea for 48 h and the infection was absent before starting mechanical ventilation . Diagnosis of pneumonia was based on radiographic finding of pulmonary infiltrate; findings should be new and progressive and at least should satisfy two clinical criteria of the following: body temperature >38°C or <35.5°C; leukocyte count > 12,000 cells/mm3 or <4000 cells/mm3; and clinical evidence of pneumonia, such as purulent secretions and a decrease in oxygenation.

Diagnosis of VAP was confirmed microbiologically by positive bronchial secretion cultures

Description

Inclusion Criteria:

  • 18 years old or greater
  • Ventilator associated pneumonia (VAP) with positive sputum culture.

Exclusion Criteria:

  • pregnancy,
  • use of immunosuppressive agents except for steroids,
  • neutropenia (white blood cell count ≤1000/mL)
  • patients whose primary diagnosis was community acquired pneumonia and other source of infection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
correlation between lung ultrasound and procalcitonin.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2020

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

September 9, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 26, 2021

Last Verified

September 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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