Bacterial Pulmonary Infection in PICU

NCT00271531 | Completed

• 2 other identifiers: 04-072BAMSG 4-03
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to develop a scoring system to allow doctors to accurately identify children on a mechanical ventilator who have bacterial pneumonia. Currently this diagnosis is very difficult to make, resulting in the overuse of antibiotics and the promotion of antibiotic-resistant bacteria in the pediatric intensive care unit (ICU). Four ICUs at 3 children's hospitals will participate. Study participants will include 150 children, ages 2 months to 17 years old who require mechanical ventilation, and in whom the bedside health care providers suspect bacterial pneumonia. Bacteria will be studied by sampling lung fluid through the breathing tube less than 12 hours after starting antibiotics, using a procedure known as "non-bronchoscopic-bronchoalveolar lavage (NB-BAL)." Participants may be involved in study related procedures for up to 31 days.

Conditions

Bacterial Infection

Keywords

bacterial infection, pneumonia, ventilation, children

Outcome Measures

Primary Outcomes (1)

• Bacterial pneumonia defined as: presence of >10^4 organisms/mL of one or more pathogenic bacterial species or isolation of a pathogenic organism from pleural fluid culture in a patient with a pulmonary infiltrate; persistence of pulmonary infiltrate.

  Day -1 through Day 3.

Secondary Outcomes (1)

• Amount of antibiotics, in terms of number and duration, for the treatment of pneumonia used in the study population and separately in subgroups defined by the threshold score for bacterial pneumonia.

  Duration of study.

Study Arms (1)

1

150 subjects greater than 48 weeks post-conception and less than 18 years of age who are mechanically ventilated and have presumed bacterial pulmonary infection.

Eligibility Criteria

• Age: 2 Months - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children, ages \> 48 weeks post-conception and \< 18 years, requiring mechanical ventilation in pediatric ICU, presence of abnormal chest x-ray, and initiation of antibiotics (less than or equal to 12 hours prior to NB-BAL).

You may qualify if:

• Parent or legal guardian has signed the informed consent.
• Age greater than 48 weeks post-conception and less than 18 years of age.
• Requiring mechanical ventilation in the intensive care unit (subjects will not be intubated solely for the purpose of this study).
• Presence of an abnormal chest x-ray (CXR) as determined by the primary care team (Note: if the attending radiologist disagrees with the reading of "abnormal CXR," the subject will be followed for safety and replaced for analysis).
• Initiation of antibiotics by the assigned health care providers for suspected bacterial pneumonia (must be less than or equal to 12 hours prior to undergoing non-bronchoscopic bronchoalveolar lavage \[NB-BAL\]).

You may not qualify if:

• Presence of severe hypoxia (PaO2/FIO2 \< 120).
• Documented or suspected increased intracranial pressure.
• Hemodynamic instability, defined as one of the following in the 4 hours preceding study entry:
• Initiation of any inotropic or vasopressor agents at any dose to improve blood pressure or tissue perfusion.
• Increase in infusion rate of any inotropic or vasopressor agents to improve blood pressure or tissue perfusion.
• Receipt of intravenous (IV) or oral (PO) antibiotics for suspected bacterial pneumonia for greater than or equal to 12 hours prior to non-bronchoscopic bronchoalveolar lavage (NB-BAL).
• Treatment for a previous episode of suspected bacterial pneumonia within three days prior to NB-BAL.
• Coagulopathy:
• Documented platelet count \<50,000 x 10\^6/mL at the time of enrollment (Exception: The subject may be enrolled if he/she receives a platelet infusion as a part of routine care that is completed within one hour of NB-BAL initiation),
• Extra-corporeal circuit, requiring anticoagulation, or
• Clinically apparent bleeding deemed important by either the PI or attending intensivist.
• Previous enrollment into this study.
• Cardiopulmonary instability during routine suctioning within 6 hours of NB-BAL.
• Oscillatory ventilation.
• Cystic fibrosis.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (4)

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal aspirate, tracheal aspirate, and non bronchoscopic bronchoalveolar lavage.

MeSH Terms

Conditions

Bacterial Infections; Pneumonia; Respiratory Aspiration

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 29, 2005
• First Posted: January 2, 2006
• Study Start: April 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: August 12, 2011

Record last verified: 2009-10

Locations

US (4)