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NCT00342589 · ClinicalTrials.gov registry record
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- 1,015
- Enrollment target
NCT00342589: Completed study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT00342589 is a clinical trial that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 1,015 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00342589 has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- 1,015 participants
- Enrollment target
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, month
Primary Outcome
Collection of Pneumocystis samples for laboratory studies
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,015 participants |
| Start Date | 1999-09-28 |
What the finished NCT00342589 record still lists
NCT00342589 is an observational study that tracks outcomes without assigning an intervention. Its 1,015 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT00342589 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00342589 about?
NCT00342589 is a clinical study titled "New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia". 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 imm...
What is the current status of trial NCT00342589?
This trial is currently completed. The enrollment target is 1,015 participants. The study started on 1999-09-28.
Who is sponsoring clinical trial NCT00342589?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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