New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia
|First Received Date ICMJE||June 19, 2006|
|Last Updated Date||December 22, 2012|
|Start Date ICMJE||April 1999|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00342589 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||New Techniques for Using a Saline Wash as a Diagnostic Tool for Pneumocystis Pneumonia|
|Official Title ICMJE||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 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:
(Bullet)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.
(Bullet)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.
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.
|Study Type ICMJE||Observational|
|Study Design ICMJE||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Condition ICMJE||Pneumocystis Pneumonia|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1500|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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.
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.
|Ages||3 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00342589|
|Other Study ID Numbers ICMJE||990084, 99-I-0084|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Institute of Allergy and Infectious Diseases (NIAID)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||November 2012|
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