Prevalence of Pneumocystis Jirovecii and of Cytomegalovirus in Bronchial Wash Fluid of Patients Undergoing Bronchoscopy (PCP-CMV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Michal Steinberg, Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01395498
First received: July 14, 2011
Last updated: February 10, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to determine the incidence of the "carriage" state (asymptomatic colonization) with Pneumocystis Jirovecii (Pneumocystic Carinii Pneumonia, PCP) and Cytomegalovirus (CMV)in the human lung. These are pathogens causing pneumonia in patients with suppressed immune system, but not known to cause disease in otherwise normal people. The investigators hypothesis is that a carriage state exists for these two pathogens. To test this hypothesis the investigators will examine bronchoalveolar lavage fluid for genetic material of these two pathogens. The study population will be patients undergoing fiberoptic bronchoscopy and lavage for indications other than diagnosis of a presumed opportunistic infection.


Condition Intervention
Patients Scheduled for Bronchoscopy
Other: laboratory testing of PCP and CMV genetic material

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence of Positive DNA of Pneumocystis Jirovecii and of Cytomegalovirus in Bronchial Wash Fluid of Patients Undergoing Fiberoptic Bronchoscopy

Resource links provided by NLM:


Further study details as provided by Carmel Medical Center:

Biospecimen Retention:   Samples With DNA

samples of bronchoalveolar lavage fluid and blood.


Estimated Enrollment: 300
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fiberoptic bronchoscopy
patients undergoing fiberoptic bronchoscopy who are not immunocompromized and in whom an opportunistic infection is not suspected.
Other: laboratory testing of PCP and CMV genetic material
laboratory testing of PCP and CMV DNA in bronchoalveolar lavage fluid, CMV PCR in blood+ serology in patients with positive BAL.

Detailed Description:

Both Pneumocystis Jirovecii (Pneumocystic Carinii Pneumonia, PCP) and Cytomegalovirus (CMV) are opportunistic pathogens known to cause infection in patients with impaired immune systems. PCP is a frequent pathogen causing respiratory tract infections in Acquired Immune Deficiency (AIDS) patients, but may also cause infection in other immunecompromised hosts. CMV is a causative agent of pneumonia mostly in transplant recipients.

For CMV pneumonia to be diagnosed in a patient with clinical signs of pneumonia, it is necessary to demonstrate the presence of the virus by its isolation, histopathologic testing, immunohistochemical analysis, or in situ hybridization. Detection of viral DNA in respiratory secretions (eg. Bronchial wash) may be too sensitive and is considered insufficient for diagnosis. However, the diagnostic methods are either not commonly performed or, in the case of histopathology, may risk severely ill patients. It is not known how often viral DNA is indeed detected in respiratory secretions of immunocompetent and immunocompromized hosts.

As for PCP, it is not known whether an asymptomatic carriage state exists for this pathogen. It has been suggested that PCP may be found in bronchial washings of asymptomatic patients, mostly corticosteroid- treated , and pregnant women. This finding has not been confirmed by other investigators, nor is it known what the prevalence of PCP colonization is in Israel. If PCP colonization is common, detection of PCP DNA in bronchial wash may represent colonization, not infection, and may mask true infection by an unidentified pathogen. Thus, it is of importance to define the prevalence of PCP in respiratory secretions in our population.

Bronchial washing is a procedure routinely performed during Fiberoptic Bronchoscopy, which includes the instillation of 10-20 ml sterile saline solution into a segmental or subsegmental bronchus. It is a safe procedure, which may rarely result in fever up to 38.5 up to a few hours after the procedure. Patients hypoxemic at room air (O2 Sat <90%) will be excluded from this study.

Study Procedures:

In order to assess the prevalence of detection of PCP and CMV DNA in respiratory secretions, we propose to prospectively perform polymerase chain reaction (PCR) analysis of PCP and of CMV DNA in bronchial wash obtained during bronchoscopy. In order to correlate CMV findings to blood antigenemia and viremia, 5 ml of blood will be drawn for analysis of CMV antibodies (IgG) and CMV DNA (PCR analysis). Blood will be drawn during insertion of venous access routinely performed for sedation during the procedure.

Patients will be those undergoing scheduled Fiberoptic Bronchoscopy for other indications and not as part of the study protocol. Indication for Fiberoptic Bronchoscopy will be recorded, as well as any associated medical condition and chronic medication

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will consist of patients cared for in the pulmonology outpatients clinic and for whom a fiberoptic bronchoscopy is indicated.

Criteria

Inclusion Criteria:

  • Patients undergoing Fiberoptic Bronchoscopy for any indication and signing an informed consent form.

Exclusion Criteria:

  • Hypoxemia < 90% at Room air
  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: NCT01395498

Contacts
Contact: Michal Shteinberg, MD, PhD 972-4-8250517 michaldan@bezeqint.net
Contact: Yochai Adir, MD 972-4-8250517 yochaiad@clalit.org.il

Locations
Israel
Pulmonology Institute, Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Michal Shteinberg, MD, Ph.D    972-4-8250342    michaldan@bezeqint.net   
Contact: Yochai Adir, MD    972-4-8250342    yochaiad@clalit.org.il   
Principal Investigator: Michal Shteinberg, MD, PhD         
Sub-Investigator: Yochai Adir, MD         
Sub-Investigator: Amir Abramovitz, MD         
Sub-Investigator: Anat Amital, MD         
Sub-Investigator: Asaf Jacobi, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Study Director: Yochai Adir, MD Pulmonology Institute, Carmel Medical Center
  More Information

No publications provided

Responsible Party: Michal Steinberg, Dr. Michal Shteinberg, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01395498     History of Changes
Other Study ID Numbers: CMC-11-0009-CTIL
Study First Received: July 14, 2011
Last Updated: February 10, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Carmel Medical Center:
CMV
PCP
bronchoalveolar lavage

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

ClinicalTrials.gov processed this record on August 28, 2014