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Search / Trial NCT00342589

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

Launched by NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) · Jun 19, 2006

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Pneumocystis Hiv Oral Wash Pcr Drug Resistance Natural History

ClinConnect Summary

This clinical trial is exploring a new way to diagnose a serious lung infection called Pneumocystis pneumonia, which can occur in people with weakened immune systems, such as those with HIV, cancer patients, or organ transplant recipients. Instead of the usual methods that involve more invasive procedures, this study is testing whether a simple salt-water (saline) mouthwash can be used to detect the infection. The researchers believe that new techniques might make it possible to identify the infection from an oral wash, even though the amount of the organism found in an oral sample is usually lower than in traditional tests.

To participate in this trial, individuals aged 3 years and older with weakened immune systems and acute pneumonia may be eligible. This includes patients undergoing procedures to obtain lung samples and healthy volunteers who may be at risk of exposure to the infection. Participants will provide an oral wash sample, which involves rinsing and swishing saline in their mouth, as well as a small blood sample. The study aims to offer a less invasive and easier way to diagnose Pneumocystis pneumonia, potentially benefiting many patients who currently face more uncomfortable testing options.

Gender

ALL

Eligibility 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.
  • 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.

About National Institute Of Allergy And Infectious Diseases (Niaid)

The National Institute of Allergy and Infectious Diseases (NIAID) is a key component of the National Institutes of Health (NIH) dedicated to advancing the understanding, prevention, and treatment of infectious and immune-mediated diseases. Through rigorous clinical trials, NIAID aims to foster innovative research that enhances public health and addresses global health challenges, including emerging infectious diseases and allergies. The institute collaborates with various partners, including academic institutions, industry, and international organizations, to translate scientific discoveries into effective therapies and vaccines. NIAID's commitment to high-quality clinical research is integral to improving health outcomes and informing policy decisions in the realm of infectious diseases and immunology.

Locations

Bethesda, Maryland, United States

Bethesda, Maryland, United States

Patients applied

JR

KD

2 patients applied

Trial Officials

Joseph A Kovacs, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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