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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00342589
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: December 2013
  Purpose

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.


Condition
Pneumocystis Pneumonia

Study Type: Observational
Official Title: Studies of Human Pneumocystis Infection

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1500
Study Start Date: April 1999
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, 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.

  Eligibility

Ages Eligible for Study:   3 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

Either:

A. Patients (male or female) who are immunosuppressed with acute pneumonia and are undergoing or have undergone a clinically indicated procedure, such as bronchoscopy or sputum induction, to obtain a respiratory sample for diagnostic purposes.

or

B. Patients (male or female) who are immunosuppressed with acute pneumonia or individuals likely to be exposed to environmental or person-to-person sources of organisms, including healthy volunteers (with or without respiratory disease), health care professionals, patient families, or other patients in health care facilities who are willing to provide oral washes, nasal samples or blood samples and to consider providing an induced sputum sample.

All ages greater than or equal to 3 years.

Only children who will be having a clinically indicated induced sputum or bronchoscopy will be included in this study (nasal specimens will not be collected from children).

Ability of individual or guardian to give informed consent.

EXCLUSION CRITERIA:

For enrollment under category B, any individual who cannot safely provide an oral wash or nasal samples (nasopharyngeal swabs, or nasal washes) as determined by the health care provider.

Pregnancy and age are not exclusion factors.

Nasal specimens will not be collected from children.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00342589

Contacts
Contact: Debra Reda, R.N. (301) 496-9320 dreda@nih.gov
Contact: Henry Masur, M.D. (301) 496-9320 hmasur@cc.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Henry Masur, M.D. National Institutes of Health Clinical Center (CC)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00342589     History of Changes
Other Study ID Numbers: 990084, 99-I-0084
Study First Received: June 19, 2006
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Pneumocystis
HIV
Oral Wash
PCR
Drug Resistance

Additional relevant MeSH terms:
Pneumonia
Pneumonia, Pneumocystis
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases, Fungal
Mycoses
Pneumocystis Infections

ClinicalTrials.gov processed this record on October 16, 2014