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

StatusCompleted
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 256 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Minor New version filed on ClinicalTrials.gov
  2. Minor 21 versions Re-verified since Jan 1, 2026, no change to tracked fieldsv235-v255
  3. Minor Trial status: Recruiting to Completed Enrollment target: estimated 1500 to confirmed 1015v234 Show all 2 changesShow less
    • Enrollment target: estimated 1500 to confirmed 1015
  4. Minor 27 versions Re-verified since Jan 14, 2025, no change to tracked fieldsv207-v233
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT00342589
Lead Sponsor National Institute of Allergy and Infectious Diseases (NIAID)
Collaborators: National Institutes of Health Clinical Center (CC)
Conditions Pneumocystis Infection, Infection, Pneumonia, Pneumocystis, Lung Disease, Fungal, Mycoses
Enrollment 1,015 participants
Start Date
Updated on ClinicalTrials.gov