Using a saline oral wash to diagnose Pneumocystis pneumonia
Studies of Human Pneumocystis Infection
This study is testing a new saline mouthwash to see if it can help diagnose Pneumocystis pneumonia in people with weakened immune systems, like those with HIV or cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 3 Years to 99 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00342589 on ClinicalTrials.gov |
What this trial studies
This study examines a new laboratory method for detecting Pneumocystis organisms using a saline oral wash. It focuses on patients with weakened immune systems, such as those with HIV or cancer, who are at risk for life-threatening pneumonia. The study aims to collect respiratory secretion specimens and blood samples to investigate Pneumocystis infection, drug resistance, and strain variation. By exploring this method, the study seeks to improve diagnostic techniques that are currently limited by more invasive procedures.
Who should consider this trial
Good fit: Ideal candidates include immunosuppressed patients with acute pneumonia and healthy volunteers who may be exposed to Pneumocystis.
Not a fit: Patients who cannot safely provide oral or nasal samples will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and more accessible method for diagnosing Pneumocystis pneumonia in immunocompromised patients.
How similar studies have performed: While this approach is innovative, it builds on existing diagnostic methods, and similar studies have shown promise in improving diagnostic techniques for infections.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Joseph A Kovacs, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
- Study coordinator: Cheryl L. Pauls
- Email: paulsc@nih.gov
- Phone: (301) 481-2260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.