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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Studies of Human Pneumocystis Infection

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 milli

Detailed Summary: 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.
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

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

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: National Institutes of Health Clinical Center (CC)

Dates:
Date Received: June 19, 2006
Date Started: April 10, 1999
Date Completion:
Last Updated: April 21, 2017
Last Verified: October 4, 2016