PneumoniaNCT00077909
Study of Lung Proteins in Patients With Pneumonia
An observational study of Pneumonia and Pulmonary Disease, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 99 years
- Conditions the study is for
- Pneumonia, Pulmonary Disease, Lung Disease
- How many people
- 750 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2004to not given
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any patient at the NIH Clinical Center who has a clinically indicated need for diagnostic bronchoscopy.@@@
Who may be able to join
- 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.
Who cannot join
- Patients undergoing bronchoscopy but not wanting to participate with either the chart review or the proteomic analysis of BAL fluid supernatant will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Biomarkers and Protein Mass Expression Profiles in Bronchoalveolar Lavage From Patients With Lung Infiltrates
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.
Read the detailed description
OBJECTIVE:
The objective of this study is to analyze bronchoalveolar lavage (BAL) fluid from patients with lung infiltrates in order to discover new biomarkers and protein/peptide expression patterns that are associated with specific types of pulmonary diseases and infections. Bronchoalveolar lavage (BAL) is a standard method to obtain lower airway samples to evaluate pulmonary infiltrates in order to diagnose infection, malignancy or non-infectious inflammation. After collecting the BAL (during a clinically indicated brochoscopy), samples are routinely sent to the clinical microbiology laboratory for stains, cultures and molecular analysis. We have recently developed a rapid, culture-independent method to identify unique peptide markers in BAL that identify specific bacterial species. We are expanding the scope of 04-CC-0119 that was based originally on collection of BAL supernatant only, to now collect, analyze and store whole (unprocessed) BAL. The availabilty of new methods of analyzing BAL will broaden the scope of the study to analyze BAL proteins, lung cells, and microbial pathogens. This will allow improved characterization of the host response to lung inflammation and infection and help to assess the feasibility of using the culture-independent approach on clinical BAL samples to identify specific pathogens.
POPULATION:
The study population will include all patients undergoing bronchoscopy for clinical indications at the Clinical Center who provide informed consent for chart review blood draw (optional), and analysis of BAL, as described in this protocol. We plan to acquire BAL samples that reflect a spectrum of community-acquired and opportunistic pathogens associated with pulmonary disease. In addition analysis of a range of non-infectious pulmonary processes (e.g. acute lung injury, acute respiratory distress syndrome and engraftment syndrome) is important to develop measures of sensitivity and specificity.
DESIGN:
This is a prospective observational study.
OUTCOME:
The expected outcome is to:
Develop a database of protein mass profiles of BAL fluid linked to specific microbiologic diagnoses.
To collect, analyze and store BAL to validate the usefulness of the genoproteomic culture-independent method of microbial identification.
To analyze lung cells associated with infectious or inflammatory pulmonary condidtions.
Our plan is to acquire 1,000 specimens from the Clinical Center with a range of clinical diagnoses including bacterial, viral, parasitic and fungal infections and sterile inflammation. When a sufficient number of samples in an individual category is collected (approximately 20-30), the samples will be analyzed with current proteomic techniques.
- Conditions
- Pneumonia, Pulmonary Disease, Lung Disease
- Keywords
- Proteomics, Infection, Pneumonia, Mass Spectrometry, BAL, Natural History, Lung, Pulmonary Disease, Lung Infiltrates
- Medical subject headings
- Pneumonia, Lung Diseases, Infections
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 |
|---|---|---|
| Group 1 | Patients with Infectious Pneumonia | |
| Group 2 | Patients with Non-Infectious Pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peptide biomarker
Detection of peptide biomarker for infectious disease as a cause of pneumonia.
Measured: Batch-driven analysis of samples.
Characterization of lung cells associated with pneumonia
Analyze lung cells associated with infectious or inflammatory pulmonary conditions.
Measured: Batch-driven analysis of samples.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2004 (estimated)
- Study start20 Feb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- Cross-sectional
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Anthony F Suffredini, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00077909
- Sponsor's protocol ID
- 040119
- Other IDs
- 04-CC-0119
- Status last verified
- 9 Apr 2026
- First submitted
- 12 Feb 2004
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28588123Wang 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.
PubMed 27117471Wang 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.
PubMed 28566732
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers and Protein Mass Expression Profiles in Bronchoalveolar Lavage From Patients With Lung Infiltrates
- ClinicalTrials.gov ID
- NCT00077909
- Acronym / sponsor ID
- 040119
- Conditions
- Pneumonia, Pulmonary Disease, Lung Disease
- Keywords
- Proteomics, Infection, Pneumonia, Mass Spectrometry, BAL, Natural History, Lung, Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 20 Feb 2004 (actual)
- First posted
- 13 Feb 2004 (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.
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.
Detailed description
OBJECTIVE:
The objective of this study is to analyze bronchoalveolar lavage (BAL) fluid from patients with lung infiltrates in order to discover new biomarkers and protein/peptide expression patterns that are associated with specific types of pulmonary diseases and infections. Bronchoalveolar lavage (BAL) is a standard method to obtain lower airway samples to evaluate pulmonary infiltrates in order to diagnose infection, malignancy or non-infectious inflammation. After collecting the BAL (during a clinically indicated brochoscopy), samples are routinely sent to the clinical microbiology laboratory for stains, cultures and molecular analysis. We have recently developed a rapid, culture-independent method to identify unique peptide markers in BAL that identify specific bacterial species. We are expanding the scope of 04-CC-0119 that was based originally on collection of BAL supernatant only, to now collect, analyze and store whole (unprocessed) BAL. The availabilty of new methods of analyzing BAL will broaden the scope of the study to analyze BAL proteins, lung cells, and microbial pathogens. This will allow improved characterization of the host response to lung inflammation and infection and help to assess the feasibility of using the culture-independent approach on clinical BAL samples to identify specific pathogens.
POPULATION:
The study population will include all patients undergoing bronchoscopy for clinical indications at the Clinical Center who provide informed consent for chart review blood draw (optional), and analysis of BAL, as described in this protocol. We plan to acquire BAL samples that reflect a spectrum of community-acquired and opportunistic pathogens associated with pulmonary disease. In addition analysis of a range of non-infectious pulmonary processes (e.g. acute lung injury, acute respiratory distress syndrome and engraftment syndrome) is important to develop measures of sensitivity and specificity.
DESIGN:
This is a prospective observational study.
OUTCOME:
The expected outcome is to:
Develop a database of protein mass profiles of BAL fluid linked to specific microbiologic diagnoses.
To collect, analyze and store BAL to validate the usefulness of the genoproteomic culture-independent method of microbial identification.
To analyze lung cells associated with infectious or inflammatory pulmonary condidtions.
Our plan is to acquire 1,000 specimens from the Clinical Center with a range of clinical diagnoses including bacterial, viral, parasitic and fungal infections and sterile inflammation. When a sufficient number of samples in an individual category is collected (approximately 20-30), the samples will be analyzed with current proteomic techniques.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients with Infectious Pneumonia |
| Group 2 | – | –Patients with Non-Infectious Pneumonia |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient at the NIH Clinical Center who has a clinically indicated need for diagnostic bronchoscopy.@@@
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients undergoing bronchoscopy but not wanting to participate with either the chart review or the proteomic analysis of BAL fluid supernatant will be excluded.
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
Peptide biomarker
Time frame: Batch-driven analysis of samples.
Detection of peptide biomarker for infectious disease as a cause of pneumonia.
Characterization of lung cells associated with pneumonia
Time frame: Batch-driven analysis of samples.
Analyze lung cells associated with infectious or inflammatory pulmonary conditions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 28588123Wang 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.
- Background: PubMed 27117471Wang 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.
- Background: PubMed 28566732Wang 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Anthony F Suffredini, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia and Pulmonary Disease, run by National Institutes of Health Clinical Center (CC) at 1 site 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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gloria Y Pastor, C.R.N.P. ((301) 402-3484, pastorg@cc.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peptide biomarker (time frame: Batch-driven analysis of samples.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00077909, which also lists 3 linked publications.
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 13 Oct 2026.