Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342589
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2006-06-19
Brief Title:
New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Studies of Human Pneumocystis Infection
Status:
RECRUITING
Status Verified Date:
2024-10-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 addl 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
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 addl 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
Detailed Description:
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 99-I-0084 | None | None | None |