Bacterial InfectionNCT00271531
Bacterial Pulmonary Infection in PICU
An observational study of Bacterial Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 months to 17 years
- Conditions the study is for
- Bacterial Infection
- How many people
- 21 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2006to May 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 months to 17 years
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- 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]).
Who cannot join
- 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).
Show all 17Show fewer
- 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.
- Single ventricle physiology.
- Positive pleural fluid culture results prior to Day -1 during the current hospitalization.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
Kosair Children's Hospital
Louisville, Kentucky, 40202
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
Official title: Derivation of a Clinical Prediction Rule for Bacterial Pulmonary Infection in Mechanically Ventilated Children
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.
Read the detailed description
The primary objective of this prospective cohort study is to derive a clinical score for predicting the absence of bacterial pulmonary infection in children requiring mechanical ventilation. This study is in preparation for designing an interventional trial whose aim will be to reduce antibiotic use in the pediatric intensive care unit (ICU) and thereby reduce the incidence of acquisition of antibiotic resistant bacteria. Secondary study objectives are to: define key characteristics of bacterial pulmonary infection in children requiring mechanical ventilation: demographics, microbiology, and predisposing factors; and assess the duration and number of antibiotics used for the treatment of pneumonia in this study population and to further assess the amount of antimicrobial therapy that could potentially be avoided in patients with a low probability of bacterial pneumonia as determined by the scoring system. The study hypothesis is that a non-invasive clinical scoring system can be devised for bacterial pulmonary infection in children requiring mechanical ventilation, to identify a threshold score below which the probability of bacterial pulmonary infection is sufficiently low that the clinician can safely withhold or stop antibiotics. The primary outcome (bacterial pneumonia) will be defined as meeting the following 2 criteria: the presence of greater than 10,000 organisms/mL of one or more pathogenic bacterial species obtained by blind non-bronchoscopic bronchoalveolar lavage (NB-BAL) on Day 0 or the isolation of a pathogenic organism from pleural fluid culture obtained between Day -1 through Day 3, in a patient with a pulmonary infiltrate; and persistence of Day 0 pulmonary infiltrate on Day 3 based on a comparison of results of chest x-rays from Days 0 and 3. The secondary endpoint is the duration and number of antibiotics used, for the treatment of pneumonia in the study population and separately in subgroups defined by the threshold score for bacterial pneumonia. Potential predictive parameters for bacterial pulmonary infection will be calculated at the initiation of antibiotics and 3 days later. These parameters will include factors in the Clinical Pulmonary Infection Score (CPIS) developed for adult patients. Additional potential predictors of bacterial pulmonary infection that may be relevant in children also will be recorded and added to the model in an attempt to improve its predictive accuracy. Study outcome will be microbiologically defined bacterial infection, using quantitative lower respiratory tract specimens collected by blind NB-BAL at entry and persistence of infiltrate on chest x-ray at Day 3. The study population will include children, age greater than 48 weeks post-conception and less than 18 years, requiring mechanical ventilation in the pediatric ICU, presence of an abnormal chest x-ray, and initiation of antibiotics less than or equal to 12 hours prior to NB-BAL by the assigned health care providers for suspected bacterial pulmonary infection.
- Conditions
- Bacterial Infection
- Keywords
- bacterial infection, pneumonia, ventilation, children
- Medical subject headings
- Bacterial Infections, Pneumonia, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Duration of study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2006 (estimated)
- Study startApr 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00271531
- Sponsor's protocol ID
- 04-072
- Other IDs
- BAMSG 4-03
- Status last verified
- Oct 2009
- First submitted
- 29 Dec 2005
- Last updated
- 12 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Derivation of a Clinical Prediction Rule for Bacterial Pulmonary Infection in Mechanically Ventilated Children
- ClinicalTrials.gov ID
- NCT00271531
- Acronym / sponsor ID
- 04-072
- Conditions
- Bacterial Infection
- Keywords
- bacterial infection, pneumonia, ventilation, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Apr 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 2 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary objective of this prospective cohort study is to derive a clinical score for predicting the absence of bacterial pulmonary infection in children requiring mechanical ventilation. This study is in preparation for designing an interventional trial whose aim will be to reduce antibiotic use in the pediatric intensive care unit (ICU) and thereby reduce the incidence of acquisition of antibiotic resistant bacteria. Secondary study objectives are to: define key characteristics of bacterial pulmonary infection in children requiring mechanical ventilation: demographics, microbiology, and predisposing factors; and assess the duration and number of antibiotics used for the treatment of pneumonia in this study population and to further assess the amount of antimicrobial therapy that could potentially be avoided in patients with a low probability of bacterial pneumonia as determined by the scoring system. The study hypothesis is that a non-invasive clinical scoring system can be devised for bacterial pulmonary infection in children requiring mechanical ventilation, to identify a threshold score below which the probability of bacterial pulmonary infection is sufficiently low that the clinician can safely withhold or stop antibiotics. The primary outcome (bacterial pneumonia) will be defined as meeting the following 2 criteria: the presence of greater than 10,000 organisms/mL of one or more pathogenic bacterial species obtained by blind non-bronchoscopic bronchoalveolar lavage (NB-BAL) on Day 0 or the isolation of a pathogenic organism from pleural fluid culture obtained between Day -1 through Day 3, in a patient with a pulmonary infiltrate; and persistence of Day 0 pulmonary infiltrate on Day 3 based on a comparison of results of chest x-rays from Days 0 and 3. The secondary endpoint is the duration and number of antibiotics used, for the treatment of pneumonia in the study population and separately in subgroups defined by the threshold score for bacterial pneumonia. Potential predictive parameters for bacterial pulmonary infection will be calculated at the initiation of antibiotics and 3 days later. These parameters will include factors in the Clinical Pulmonary Infection Score (CPIS) developed for adult patients. Additional potential predictors of bacterial pulmonary infection that may be relevant in children also will be recorded and added to the model in an attempt to improve its predictive accuracy. Study outcome will be microbiologically defined bacterial infection, using quantitative lower respiratory tract specimens collected by blind NB-BAL at entry and persistence of infiltrate on chest x-ray at Day 3. The study population will include children, age greater than 48 weeks post-conception and less than 18 years, requiring mechanical ventilation in the pediatric ICU, presence of an abnormal chest x-ray, and initiation of antibiotics less than or equal to 12 hours prior to NB-BAL by the assigned health care providers for suspected bacterial pulmonary infection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 2 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (5 listed)
- 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]).
Key exclusion criteria (17 listed)
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Time frame: Day -1 through Day 3.
1 secondary outcome
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.
Time frame: Duration of study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Day -1 through Day 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2011.