New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
| Status: | Recruiting |
|---|---|
| Conditions: | Pneumonia, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 3 - 99 |
| Updated: | 4/6/2019 |
| Start Date: | April 10, 1999 |
| Contact: | Debra Reda, R.N. |
| Email: | dreda@nih.gov |
| Phone: | (301) 496-9320 |
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.
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.
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.
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.
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.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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