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To Develop a New Technique to Predict the Occurrence of Pneumocystis Pneumonia, Track Its Epidemiology, Diagnose Acute Disease, and Predict and Monitor the Response to Various Therapeutic Agents


N/A
3 Years
N/A
Open (Enrolling)
Both
Pneumocystis Pneumonia

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Trial Information

To Develop a New Technique to Predict the Occurrence of Pneumocystis Pneumonia, Track Its Epidemiology, Diagnose Acute Disease, and Predict and Monitor the Response to Various Therapeutic Agents


This study is designed to collect respiratory secretion specimens to assess new techniques
to diagnose pneumocystis infection and disease. The diagnosis of pneumocystis pneumonia has
traditionally relied on demonstration of organisms by direct microscopy in either a sample
of sputum or bronchoalveolar lavage or lung tissue. Obtaining adequate sputum has required
expertise that not all institutions have. Bronchoalveolar lavage and lung biopsy share the
disadvantage of being invasive and cause patient discomfort and expense. Nucleic acid
amplification technology offers the potential to detect pneumocystis in easily obtained
specimens, such as oral washes or nasal samples, to detect genes associated with drug
resistance, and to assess strain variation. The goals of this project are to develop a
nucleic acid amplification technique that could provide an easier method to diagnose acute
disease and to detect drug resistant strains. 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 develop
techniques that can be the basis of definitive studies on diagnosis, epidemiology, and
transmission of pneumocystis.

Inclusion Criteria


- INCLUSION CRITERIA:

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:

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.

For drawing 30 ml blood, age less than 18 years and hemoglobin less than 9.0 g/dl.

Type of Study:

Observational

Study Design:

N/A

Principal Investigator

Henry Masur, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institutes of Health Clinical Center (CC)

Authority:

United States: Federal Government

Study ID:

990084

NCT ID:

NCT00342589

Start Date:

April 1999

Completion Date:

Related Keywords:

  • Pneumocystis Pneumonia
  • Pneumocystis
  • HIV
  • Oral Wash
  • PCR
  • Drug Resistance
  • Pneumonia
  • Pneumonia, Pneumocystis

Name

Location

National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892