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New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia

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ClinicalTrials.gov Identifier: NCT00342589
Recruitment Status : Recruiting
First Posted : June 21, 2006
Last Update Posted : January 5, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Description
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Brief 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 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.


Condition or disease
Pneumocystis Infection Infection Pneumonia, Pneumocystis Lung Disease, Fungal Mycoses

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
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Studies of Human Pneumocystis Infection
Actual Study Start Date : September 28, 1999

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. Collection of Pneumocystis samples [ Time Frame: July 2018 ]
    Collection of Pneumocystis samples for laboratory studies


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Years to 99 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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.
Criteria
  • INCLUSION CRITERIA:

Either:

A. 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

B. 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.

EXCLUSION CRITERIA:

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00342589


Contacts
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Contact: Cheryl L. Chairez (301) 496-3840 chairezc@mail.nih.gov
Contact: Joseph A Kovacs, M.D. (301) 496-9907 jkovacs@mail.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Joseph A Kovacs, M.D. National Institutes of Health Clinical Center (CC)
More Information
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Additional Information:

Publications:

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Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00342589    
Other Study ID Numbers: 990084
99-I-0084
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: January 5, 2021
Last Verified: July 21, 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) ):
Pneumocystis
HIV
Oral Wash
PCR
Drug Resistance
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Mycoses
Pneumonia, Pneumocystis
Pneumocystis Infections
 Lung Diseases, Fungal
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections