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

NCT04563104 | Completed FDA Drug

• 1 other identifier: R 49 / 2020
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ventilator Associated Pneumonia

Outcome Measures

Primary Outcomes (1)

• correlation between lung ultrasound and procalcitonin.

  7 days

Interventions

Lung Ultrasound DIAGNOSTIC_TEST

We will evaluate the role of lung ultrasound on the duration of antibiotics, we hypothesize that ultrasound imaging may have a role, will be correlated with, procalcitonin (PCT). The created database will help in establishing conclusion and recommendations that will help to improve the antibiotics duration and decrease the resistance.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Egypt

Location

MeSH Terms

Conditions

Pneumonia, Ventilator-Associated

Condition Hierarchy (Ancestors)

Healthcare-Associated Pneumonia; Cross Infection; Infections; Pneumonia; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: September 9, 2020
• First Posted: September 24, 2020
• Study Start: October 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: September 1, 2021
• Last Updated: September 28, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)