Pneumocystis InfectionNCT00342589
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
An observational study of Pneumocystis Infection and Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This study will examine the effectiveness of a new laboratory method for detecting pneumocystis organisms in a salt-water (saline) oral wash. Pneumocystis infection in people with weakened immunity especially patients with HIV infection or cancer, organ transplant recipients and people receiving immune suppressing… Read more about this study
- Who is it for?
- Ages 3 to 99 years
- Conditions the study is for
- Pneumocystis Infection, Infection, Pneumonia, Pneumocystis
- How many people
- 1,015 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 1999to not given
- 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 3 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients (male or female) who are immunosuppressed with acute pneumonia and are undergoing or have undergone a clinically indicated procedure, such as bronchoscopy or sputum induction, to obtain a respiratory sample for diagnostic purposes. AND Patients (male or female) who are immunosuppressed with acute pneumonia or individuals likely to be exposed to environmental or person-to-person sources of organisms, including healthy volunteers (with or without respiratory disease), health care professionals, patient families, or other patients in health care facilities who are willing to provide oral washes, nasal samples or blood samples and to consider providing an induced sputum sample.
Who may be able to join
- Either:
- Patients (male or female) who are immunosuppressed with acute pneumonia and are undergoing or have undergone a clinically indicated procedure, such as bronchoscopy or sputum induction, to obtain a respiratory sample for diagnostic purposes.
- or
- Patients (male or female) who are immunosuppressed with acute pneumonia or individuals likely to be exposed to environmental or person-to-person sources of organisms, including healthy volunteers (with or without respiratory disease), health care professionals, patient families, or other patients in health care facilities who are willing to provide oral washes, nasal samples or blood samples and to consider providing an induced sputum sample.
- All ages greater than or equal to 3 years.
- Ability of individual or guardian to give informed consent.
Who cannot join
- For enrollment under category B, any individual who cannot safely provide an oral wash or nasal samples (nasopharyngeal swabs, or nasal washes) as determined by the health care provider.
- Pregnancy and age are not exclusion factors.
- Nasal specimens will not be collected from children.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Studies of Human Pneumocystis Infection
This study will examine the effectiveness of a new laboratory method for detecting pneumocystis organisms in a salt-water (saline) oral wash. Pneumocystis infection in people with weakened immunity especially patients with HIV infection or cancer, organ transplant recipients and people receiving immune suppressing therapy can cause life-threatening pneumonia. Currently, pneumocystis infection is diagnosed by sputum analysis or bronchoalveolar lavage. For the sputum analysis, patients are induced to produce a sputum sample (liquid discharge from the lung) using a saline mist; however, many hospitals lack the expertise to perform this procedure. The second method, bronchoalveolar lavage, involves inserting a flexible tube into the lung and injecting saline to produce a specimen for diagnosis. This method, however, is time-consuming and can be uncomfortable. New techniques may allow the use of an oral wash to diagnose pneumocystis, even though an oral sample contains far fewer organisms than are obtained with the current methods. This study will examine whether new techniques, such as nucleic acid amplification, may enable a simple oral wash to be used effectively for diagnosis of pneumocystis infection.
Patients 3 years of age and older with weakened immunity who have acute pneumonia may be eligible for this study. In addition, people at increased risk of infection with pneumocystis, including health care professionals, family members of patients, and other patients in health care facilities, may participate.
Read more
Participants will have a medical history and review of medical records to determine their health status and determine if they have had recent respiratory problems or documented PCP. They will then provide an oral wash sample. For this procedure, subjects first rinse their mouth well. Then, they vigorously swish 50 milliliters of saline for 5 to 10 seconds and immediately repeat the procedure to provide two specimens. Washes may be requested daily, weekly, monthly, or for a period of time to be specified. Participants will also have two tubes of blood drawn (total of 20 milliliters, or 4 teaspoons) to test for evidence of pneumocystis.
Although no other tests are required for this protocol, participants may be asked to provide optional add'l samples, as follows:
If a sputum or bronchoalveolar lavage sample is required in the course of the patient s clinical mgmt, enough material will be obtained, if possible, for research purposes as well as what is needed for routine care.
An induced sputum sample may be requested just for this protocol. For this procedure, a mask with a saline mist is placed over the face, inducing a cough that, it is hoped, will produce sputum from the lungs.
Read the detailed description
This study is designed to collect respiratory secretion specimens and blood samples to facilitate studies of human Pneumocystis infection and disease, to detect genes associated with drug resistance, and to assess strain variation. This study will also contribute information about the epidemiology of Pneumocystis by assessing normal volunteers who are exposed to Pneumocystis, e.g. health professionals, and looking at strain variation among isolates from patients and, if positives are found, from healthy volunteers. This study will potentially facilitate development of techniques that can be the basis of definitive studies on diagnosis, epidemiology, and transmission of Pneumocystis.
- Keywords
- Pneumocystis, HIV, Oral Wash, PCR, Drug Resistance, Natural History
- Medical subject headings
- Pneumocystis Infections, Infections, Pneumonia, Pneumocystis, Lung Diseases, Fungal, Mycoses
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 |
|---|---|---|
| Healthy Volunteers | Individuals exposed to environmental or person-to-person sources of organisms, including healthy volunteers, health care professionals, patient families, or other patients in health care facilities | |
| Patients | Patients immunosuppressed with acute pneumonia and are undergoing or have undergone a clinically indicated procedure to obtain a respiratory sample for diagnostic purposes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of Pneumocystis samples
Collection of Pneumocystis samples for laboratory studies
Measured: July 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start28 Sep 1999
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 Pneumocystis 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,015 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Responsible party
- Sponsor
- Investigators
- Joseph A Kovacs, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00342589
- Sponsor's protocol ID
- 990084
- Other IDs
- 99-I-0084
- Status last verified
- 11 Feb 2026
- First submitted
- 19 Jun 2006
- Last updated
- 16 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kovacs JA, Masur H. Evolving health effects of Pneumocystis: one hundred years of progress in diagnosis and treatment. JAMA. 2009 Jun 24;301(24):2578-85. doi: 10.1001/jama.2009.880.
PubMed 19549975Larsen HH, Huang L, Kovacs JA, Crothers K, Silcott VA, Morris A, Turner JR, Beard CB, Masur H, Fischer SH. A prospective, blinded study of quantitative touch-down polymerase chain reaction using oral-wash samples for diagnosis of Pneumocystis pneumonia in HIV-infected patients. J Infect Dis. 2004 May 1;189(9):1679-83. doi: 10.1086/383322. Epub 2004 Apr 16.
PubMed 15116305Larsen HH, Kovacs JA, Stock F, Vestereng VH, Lundgren B, Fischer SH, Gill VJ. Development of a rapid real-time PCR assay for quantitation of Pneumocystis carinii f. sp. carinii. J Clin Microbiol. 2002 Aug;40(8):2989-93. doi: 10.1128/JCM.40.8.2989-2993.2002.
PubMed 12149363
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Human Pneumocystis Infection
- ClinicalTrials.gov ID
- NCT00342589
- Acronym / sponsor ID
- 990084
- Keywords
- Pneumocystis, HIV, Oral Wash, PCR, Drug Resistance, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Study start
- 28 Sep 1999 (actual)
- First posted
- 21 Jun 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.
This study will examine the effectiveness of a new laboratory method for detecting pneumocystis organisms in a salt-water (saline) oral wash. Pneumocystis infection in people with weakened immunity especially patients with HIV infection or cancer, organ transplant recipients and people receiving immune suppressing therapy can cause life-threatening pneumonia. Currently, pneumocystis infection is diagnosed by sputum analysis or bronchoalveolar lavage. For the sputum analysis, patients are induced to produce a sputum sample (liquid discharge from the lung) using a saline mist; however, many hospitals lack the expertise to perform this procedure. The second method, bronchoalveolar lavage, involves inserting a flexible tube into the lung and injecting saline to produce a specimen for diagnosis. This method, however, is time-consuming and can be uncomfortable. New techniques may allow the use of an oral wash to diagnose pneumocystis, even though an oral sample contains far fewer organisms than are obtained with the current methods. This study will examine whether new techniques, such as nucleic acid amplification, may enable a simple oral wash to be used effectively for diagnosis of pneumocystis infection.
Patients 3 years of age and older with weakened immunity who have acute pneumonia may be eligible for this study. In addition, people at increased risk of infection with pneumocystis, including health care professionals, family members of patients, and other patients in health care facilities, may participate.
Participants will have a medical history and review of medical records to determine their health status and determine if they have had recent respiratory problems or documented PCP. They will then provide an oral wash sample. For this procedure, subjects first rinse their mouth well. Then, they vigorously swish 50 milliliters of saline for 5 to 10 seconds and immediately repeat the procedure to provide two specimens. Washes may be requested daily, weekly, monthly, or for a period of time to be specified. Participants will also have two tubes of blood drawn (total of 20 milliliters, or 4 teaspoons) to test for evidence of pneumocystis.
Although no other tests are required for this protocol, participants may be asked to provide optional add'l samples, as follows:
If a sputum or bronchoalveolar lavage sample is required in the course of the patient s clinical mgmt, enough material will be obtained, if possible, for research purposes as well as what is needed for routine care.
An induced sputum sample may be requested just for this protocol. For this procedure, a mask with a saline mist is placed over the face, inducing a cough that, it is hoped, will produce sputum from the lungs.
Detailed description
This study is designed to collect respiratory secretion specimens and blood samples to facilitate studies of human Pneumocystis infection and disease, to detect genes associated with drug resistance, and to assess strain variation. This study will also contribute information about the epidemiology of Pneumocystis by assessing normal volunteers who are exposed to Pneumocystis, e.g. health professionals, and looking at strain variation among isolates from patients and, if positives are found, from healthy volunteers. This study will potentially facilitate development of techniques that can be the basis of definitive studies on diagnosis, epidemiology, and transmission of Pneumocystis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | – | –Individuals exposed to environmental or person-to-person sources of organisms, including healthy volunteers, health care professionals, patient families, or other patients in health care facilities |
| Patients | – | –Patients immunosuppressed with acute pneumonia and are undergoing or have undergone a clinically indicated procedure to obtain a respiratory sample for diagnostic purposes. |
Who may qualify
- Ages
- 3 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients (male or female) who are immunosuppressed with acute pneumonia and are undergoing or have undergone a clinically indicated procedure, such as bronchoscopy or sputum induction, to obtain a respiratory sample for diagnostic purposes. AND Patients (male or female) who are immunosuppressed with acute pneumonia or individuals likely to be exposed to environmental or person-to-person sources of organisms, including healthy volunteers (with or without respiratory disease), health care professionals, patient families, or other patients in health care facilities who are willing to provide oral washes, nasal samples or blood samples and to consider providing an induced sputum sample.
Key inclusion criteria (6 listed)
- Patients (male or female) who are immunosuppressed with acute pneumonia and are undergoing or have undergone a clinically indicated procedure, such as bronchoscopy or sputum induction, to obtain a respiratory sample for diagnostic purposes.
- or
- Patients (male or female) who are immunosuppressed with acute pneumonia or individuals likely to be exposed to environmental or person-to-person sources of organisms, including healthy volunteers (with or without respiratory disease), health care professionals, patient families, or other patients in health care facilities who are willing to provide oral washes, nasal samples or blood samples and to consider providing an induced sputum sample.
- All ages greater than or equal to 3 years.
- Ability of individual or guardian to give informed consent.
Key exclusion criteria (3 listed)
- For enrollment under category B, any individual who cannot safely provide an oral wash or nasal samples (nasopharyngeal swabs, or nasal washes) as determined by the health care provider.
- Pregnancy and age are not exclusion factors.
- Nasal specimens will not be collected from children.
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
Collection of Pneumocystis samples
Time frame: July 2018
Collection of Pneumocystis samples for laboratory studies
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 16 Sep 2026.
- Background: PubMed 19549975Kovacs JA, Masur H. Evolving health effects of Pneumocystis: one hundred years of progress in diagnosis and treatment. JAMA. 2009 Jun 24;301(24):2578-85. doi: 10.1001/jama.2009.880.
- Background: PubMed 15116305Larsen HH, Huang L, Kovacs JA, Crothers K, Silcott VA, Morris A, Turner JR, Beard CB, Masur H, Fischer SH. A prospective, blinded study of quantitative touch-down polymerase chain reaction using oral-wash samples for diagnosis of Pneumocystis pneumonia in HIV-infected patients. J Infect Dis. 2004 May 1;189(9):1679-83. doi: 10.1086/383322. Epub 2004 Apr 16.
- Background: PubMed 12149363Larsen HH, Kovacs JA, Stock F, Vestereng VH, Lundgren B, Fischer SH, Gill VJ. Development of a rapid real-time PCR assay for quantitation of Pneumocystis carinii f. sp. carinii. J Clin Microbiol. 2002 Aug;40(8):2989-93. doi: 10.1128/JCM.40.8.2989-2993.2002.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Joseph A Kovacs, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Pneumocystis Infection and Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 6 inclusion and 3 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 16 Sep 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?
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?
Collection of Pneumocystis samples (time frame: July 2018). 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 NCT00342589, 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 16 Sep 2026.