NCT00077909

Brief Summary

This study will examine the different types of proteins present in the lungs of patients with pneumonia to explore the causes of different types of the disease. Pneumonia is a condition that causes lung inflammation AND is often caused by an infection. It is usually diagnosed by lung x-rays and listening to the chest with a stethoscope. This method can diagnose pneumonia, but it does not provide information on the cause of the inflammation - information that might be helpful in guiding treatment. This study will measure proteins in the lungs of patients to see if certain proteins are associated with specific forms of pneumonia, and can thus serve as biomarkers for disease. Patients undergoing diagnostic bronchoscopy at the NIH Clinical Center may participate in this study. Patients will undergo bronchoscopy and bronchoalveolar lavage as scheduled for their medical care. For this procedure, the patient's mouth and throat are numbed with lidocaine; a sedative may be given for comfort. A thin flexible tube called a bronchoscope is advanced through the nose or mouth into the lung airways to examine the airways carefully. Saline (salt water) is then injected through the bronchoscope into the air passage, acting as a rinse. A sample of fluid is then withdrawn for microscopic examination. Researchers in the current study will use some of the fluid obtained from the lavage to examine for protein content. In addition to the bronchoscopy and bronchoalveolar lavage, participants will have about 2 tablespoons of blood drawn to compare blood test results with the results of the lung washings. Patients' medical records will be reviewed to obtain information on past medical history, current medical treatment, vital signs, and results of x-ray tests. ...

Trial Health

75
On Track

Trial Health Score

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

Enrollment
750

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

February 12, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 13, 2004

Completed
7 days until next milestone

Study Start

First participant enrolled

February 20, 2004

Completed
Last Updated

June 8, 2026

Status Verified

April 9, 2026

First QC Date

February 12, 2004

Last Update Submit

June 5, 2026

Conditions

Keywords

ProteomicsInfectionPneumoniaMass SpectrometryBALNatural HistoryLungPulmonary DiseaseLung Infiltrates

Outcome Measures

Primary Outcomes (2)

  • Peptide biomarker

    Detection of peptide biomarker for infectious disease as a cause of pneumonia.

    Batch-driven analysis of samples.

  • Characterization of lung cells associated with pneumonia

    Analyze lung cells associated with infectious or inflammatory pulmonary conditions.

    Batch-driven analysis of samples.

Study Arms (2)

Group 1

Patients with Infectious Pneumonia

Group 2

Patients with Non-Infectious Pneumonia

Eligibility Criteria

Age3 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient at the NIH Clinical Center who has a clinically indicated need for diagnostic bronchoscopy.@@@

You may qualify if:

  • All eligible patients undergoing diagnostic bronchoscopy who provide consent for proteomic analysis of BAL fluid supernatant and chart review of patient characteristics will be included in this study.
  • A parent/guardian may provide consent for a child age 17 or under and a Legally Authorized Representative (LAR) may provide consent for adults unable to consent.

You may not qualify if:

  • Patients undergoing bronchoscopy but not wanting to participate with either the chart review or the proteomic analysis of BAL fluid supernatant will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (3)

  • Wang H, Drake SK, Yong C, Gucek M, Lyes MA, Rosenberg AZ, Soderblom E, Arthur Moseley M, Dekker JP, Suffredini AF. A Genoproteomic Approach to Detect Peptide Markers of Bacterial Respiratory Pathogens. Clin Chem. 2017 Aug;63(8):1398-1408. doi: 10.1373/clinchem.2016.269647. Epub 2017 Jun 6.

    PMID: 28588123BACKGROUND
  • Wang H, Drake SK, Yong C, Gucek M, Tropea M, Rosenberg AZ, Dekker JP, Suffredini AF. A Novel Peptidomic Approach to Strain Typing of Clinical Acinetobacter baumannii Isolates Using Mass Spectrometry. Clin Chem. 2016 Jun;62(6):866-75. doi: 10.1373/clinchem.2015.253468. Epub 2016 Apr 26.

    PMID: 27117471BACKGROUND
  • Wang H, Drake SK, Youn JH, Rosenberg AZ, Chen Y, Gucek M, Suffredini AF, Dekker JP. Peptide Markers for Rapid Detection of KPC Carbapenemase by LC-MS/MS. Sci Rep. 2017 May 31;7(1):2531. doi: 10.1038/s41598-017-02749-2.

    PMID: 28566732BACKGROUND

Related Links

MeSH Terms

Conditions

PneumoniaLung DiseasesInfections

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsRespiratory Tract Diseases

Study Officials

  • Anthony F Suffredini, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gloria Y Pastor, R.N.

CONTACT

Anthony F Suffredini, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2004

First Posted

February 13, 2004

Study Start

February 20, 2004

Last Updated

June 8, 2026

Record last verified: 2026-04-09

Locations