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

NCT00342589 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1015

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Pneumocystis Infection
  • Infection
  • Pneumonia, Pneumocystis
  • Lung Disease, Fungal
  • Mycoses

Sponsors & Collaborators

  • National Institutes of Health Clinical Center (CC)

    collaborator NIH

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Joseph A Kovacs, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
3 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-09-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00342589 on ClinicalTrials.gov