Patients Scheduled for BronchoscopyPCP-CMVNCT01395498
Prevalence of Pneumocystis Jirovecii and of Cytomegalovirus in Bronchial Wash Fluid of Patients Undergoing Bronchoscopy
An observational study of Patients Scheduled for Bronchoscopy, run by Carmel Medical Center at 1 site in Israel.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Scheduled for Bronchoscopy
- What is being tested?
- laboratory testing of PCP and CMV genetic material
- How many people
- 93 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of patients cared for in the pulmonology outpatients clinic and for whom a fiberoptic bronchoscopy is indicated.
Who may be able to join
- Patients undergoing Fiberoptic Bronchoscopy for any indication and signing an informed consent form.
Who cannot join
- Hypoxemia < 90% at Room air
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Positive DNA of Pneumocystis Jirovecii and of Cytomegalovirus in Bronchial Wash Fluid of Patients Undergoing Fiberoptic Bronchoscopy
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.
Read the 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
- Conditions
- Patients Scheduled for Bronchoscopy
- Being tested
- laboratory testing of PCP and CMV genetic material
- Keywords
- CMV, PCP, bronchoalveolar lavage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory testing of PCP and CMV genetic materialOther
laboratory testing of PCP and CMV DNA in bronchoalveolar lavage fluid, CMV PCR in blood+ serology in patients with positive BAL.
| Study group | Role | What they receive |
|---|---|---|
| fiberoptic bronchoscopy | patients undergoing fiberoptic bronchoscopy who are not immunocompromized and in whom an opportunistic infection is not suspected. Receives: Other: laboratory testing of PCP and CMV genetic material |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionFeb 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients Scheduled for BronchoscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Steinberg, Carmel Medical Center
- Investigators
- Yochai Adir, MD, Study director, Pulmonology Institute, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01395498
- Sponsor's protocol ID
- CMC-11-0009-CTIL
- Acronym
- PCP-CMV
- Status last verified
- Jul 2016
- First submitted
- 14 Jul 2011
- Last updated
- 28 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Shteinberg M, Shaked-Mishan P, Kinarti A, Abramovitch A, Amital A, Jacobi A, Kolup Feldmann AE, Shiner M, Gershtein V, Weber G, Adir Y. Asymptomatic carriage of Pneumocystis jirovecii and cytomegalovirus in lungs of immunocompetent patients. Lung. 2014 Dec;192(6):875-9. doi: 10.1007/s00408-014-9644-z. Epub 2014 Sep 9.
PubMed 25201088
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Positive DNA of Pneumocystis Jirovecii and of Cytomegalovirus in Bronchial Wash Fluid of Patients Undergoing Fiberoptic Bronchoscopy
- ClinicalTrials.gov ID
- NCT01395498
- Acronym / sponsor ID
- PCP-CMV / CMC-11-0009-CTIL
- Conditions
- Patients Scheduled for Bronchoscopy
- Keywords
- CMV, PCP, bronchoalveolar lavage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 15 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fiberoptic bronchoscopy | – | Other: laboratory testing of PCP and CMV genetic materialpatients undergoing fiberoptic bronchoscopy who are not immunocompromized and in whom an opportunistic infection is not suspected. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of patients cared for in the pulmonology outpatients clinic and for whom a fiberoptic bronchoscopy is indicated.
Key inclusion criteria (1 listed)
- Patients undergoing Fiberoptic Bronchoscopy for any indication and signing an informed consent form.
Key exclusion criteria (1 listed)
- Hypoxemia < 90% at Room air
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory testing of PCP and CMV genetic materiallaboratory testing of PCP and CMV DNA in bronchoalveolar lavage fluid, CMV PCR in blood+ serology in patients with positive BAL. | Other | fiberoptic bronchoscopy |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2016.
- Results publication: PubMed 25201088Shteinberg M, Shaked-Mishan P, Kinarti A, Abramovitch A, Amital A, Jacobi A, Kolup Feldmann AE, Shiner M, Gershtein V, Weber G, Adir Y. Asymptomatic carriage of Pneumocystis jirovecii and cytomegalovirus in lungs of immunocompetent patients. Lung. 2014 Dec;192(6):875-9. doi: 10.1007/s00408-014-9644-z. Epub 2014 Sep 9.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yochai Adir, MD study director
Pulmonology Institute, Carmel Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Scheduled for Bronchoscopy, run by Carmel Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01395498, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2016.