HIVNCT01212042
Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections
An observational study of HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens… Read more about this study
- Who is it for?
- Ages 2 years and older
- Conditions the study is for
- HIV
- How many people
- 129 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2010to 5 Apr 2016
- 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 2 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects may be included in this study if they:
- Are 2 years of age and older.
- Are being evaluated for a respiratory infection.
- Are having respiratory specimens collected as part of their clinical evaluation.
- Agree to have specimens stored for future research.
Who cannot join
- Patients unable or unwilling to give informed consent will be excluded from the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens that can be detected in this population. Conventional microbiology is time-consuming and cumbersome, and the capability of local laboratories to assess specimens for rare or unusual pathogens is often limited. This study will evaluate if a newer technology can be effectively utilized in the identification of a broader range of infectious agents relative to conventional procedures.
Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical specimen. The technology has had limited clinical application, but early studies have shown its effectiveness in accurately identifying a large number of viral and bacterial organisms. In contrast to conventional microbiological procedures based on phenotypic traits (growth characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to detect and identify the species, serotype/subtype, or strain of the infectious agent.
Read more
Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage, BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be analyzed using the customized microarray chip. The specimens will be collected as part of the patients routine clinical care. The results of the TessArray microarray analysis will not be available to the clinician and therefore will not have any effect on the clinical care of the patients.
The results of the microarray analysis from each site will be compared to that site s clinical laboratory results, and the data will be analyzed by site.
Read the detailed description
Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens that can be detected in this population. Conventional microbiology is time-consuming and cumbersome, and the capability of local laboratories to assess specimens for rare or unusual pathogens is often limited. This study will evaluate if a newer technology can be effectively utilized in the identification of a broader range of infectious agents relative to conventional procedures.
Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical specimen. The technology has had limited clinical application, but early studies have shown its effectiveness in accurately identifying a large number of viral and bacterial organisms. In contrast to conventional microbiological procedures based on phenotypic traits (growth characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to detect and identify the species, serotype/subtype, or strain of the infectious agent.
Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage, BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be analyzed using the customized microarray chip. The specimens will be collected as part of the patients routine clinical care. The results of the TessArray microarray analysis will not be available to the clinician and therefore will not have any effect on the clinical care of the patients.
The results of the microarray analysis from each site will be compared to that site s clinical laboratory results, and the data will be analyzed by site.
- Conditions
- HIV
- Keywords
- Pneumonia, Pulmonary Pathogens, HIV, Immunocompromised Host, Respiratory Infection, Mycobacteria
- Medical subject headings
- Pneumonia, Respiratory Tract Infections, Mycobacterium Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity, compared to standard microbiological methods, of a customized TessArray microarray for the diagnosis of respiratory infections.
Measured: At time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study start1 Sep 2010
- Study completion5 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HIVStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Responsible party
- Sponsor
- Investigators
- Joseph A Kovacs, M.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212042
- Sponsor's protocol ID
- 100200
- Other IDs
- 10-CC-0200
- Status last verified
- 5 Apr 2016
- First submitted
- 29 Sep 2010
- Last updated
- 5 Apr 2018
- Results posted
- No
Publications
Yen KT, Lee AS, Krowka MJ, Burger CD. Pulmonary complications in bone marrow transplantation: a practical approach to diagnosis and treatment. Clin Chest Med. 2004 Mar;25(1):189-201. doi: 10.1016/S0272-5231(03)00121-7.
PubMed 15062610Boyton RJ. Infectious lung complications in patients with HIV/AIDS. Curr Opin Pulm Med. 2005 May;11(3):203-7. doi: 10.1097/01.mcp.0000156992.53246.f8.
PubMed 15818180Hirschtick RE, Glassroth J, Jordan MC, Wilcosky TC, Wallace JM, Kvale PA, Markowitz N, Rosen MJ, Mangura BT, Hopewell PC. Bacterial pneumonia in persons infected with the human immunodeficiency virus. Pulmonary Complications of HIV Infection Study Group. N Engl J Med. 1995 Sep 28;333(13):845-51. doi: 10.1056/NEJM199509283331305.
PubMed 7651475
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiplex Microarray Chip-Based Diagnosis of Respiratory Infections
- ClinicalTrials.gov ID
- NCT01212042
- Acronym / sponsor ID
- 100200
- Conditions
- HIV
- Keywords
- Pneumonia, Pulmonary Pathogens, HIV, Immunocompromised Host, Respiratory Infection, Mycobacteria
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 129 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Collaborators
- National Institutes of Health Clinical Center (CC)
- Study start
- 1 Sep 2010
- Study completion
- 5 Apr 2016
- First posted
- 30 Sep 2010 (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.
Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens that can be detected in this population. Conventional microbiology is time-consuming and cumbersome, and the capability of local laboratories to assess specimens for rare or unusual pathogens is often limited. This study will evaluate if a newer technology can be effectively utilized in the identification of a broader range of infectious agents relative to conventional procedures.
Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical specimen. The technology has had limited clinical application, but early studies have shown its effectiveness in accurately identifying a large number of viral and bacterial organisms. In contrast to conventional microbiological procedures based on phenotypic traits (growth characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to detect and identify the species, serotype/subtype, or strain of the infectious agent.
Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage, BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be analyzed using the customized microarray chip. The specimens will be collected as part of the patients routine clinical care. The results of the TessArray microarray analysis will not be available to the clinician and therefore will not have any effect on the clinical care of the patients.
The results of the microarray analysis from each site will be compared to that site s clinical laboratory results, and the data will be analyzed by site.
Detailed description
Respiratory infections have a high associated morbidity and mortality, especially in immunocompromised patients. To initiate effective treatment of respiratory infections, it is essential that a rapid and thorough laboratory analysis of respiratory specimens be performed, given the wide range of pulmonary pathogens that can be detected in this population. Conventional microbiology is time-consuming and cumbersome, and the capability of local laboratories to assess specimens for rare or unusual pathogens is often limited. This study will evaluate if a newer technology can be effectively utilized in the identification of a broader range of infectious agents relative to conventional procedures.
Resequencing Pathogen Microarray (RPM) technology developed by TessArae , LLC which ceased operations in July 2014) uses a microarray chip to identify multiple pathogens in a clinical specimen. The technology has had limited clinical application, but early studies have shown its effectiveness in accurately identifying a large number of viral and bacterial organisms. In contrast to conventional microbiological procedures based on phenotypic traits (growth characteristic and enzymatic activity), this is microarray utilizes DNA sequence analysis to detect and identify the species, serotype/subtype, or strain of the infectious agent.
Aliquots of respiratory specimens (initially, specimens collected by bronchoalveolar lavage, BAL) from 200 patients at the NIH Clinical Center and the Washington Hospital Center will be analyzed using the customized microarray chip. The specimens will be collected as part of the patients routine clinical care. The results of the TessArray microarray analysis will not be available to the clinician and therefore will not have any effect on the clinical care of the patients.
The results of the microarray analysis from each site will be compared to that site s clinical laboratory results, and the data will be analyzed by site.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Are 2 years of age and older.
- Are being evaluated for a respiratory infection.
- Are having respiratory specimens collected as part of their clinical evaluation.
- Agree to have specimens stored for future research.
Key exclusion criteria (1 listed)
- Patients unable or unwilling to give informed consent will be excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The sensitivity, compared to standard microbiological methods, of a customized TessArray microarray for the diagnosis of respiratory infections.
Time frame: At time of enrollment
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2018.
- Background: PubMed 15062610Yen KT, Lee AS, Krowka MJ, Burger CD. Pulmonary complications in bone marrow transplantation: a practical approach to diagnosis and treatment. Clin Chest Med. 2004 Mar;25(1):189-201. doi: 10.1016/S0272-5231(03)00121-7.
- Background: PubMed 15818180Boyton RJ. Infectious lung complications in patients with HIV/AIDS. Curr Opin Pulm Med. 2005 May;11(3):203-7. doi: 10.1097/01.mcp.0000156992.53246.f8.
- Background: PubMed 7651475Hirschtick RE, Glassroth J, Jordan MC, Wilcosky TC, Wallace JM, Kvale PA, Markowitz N, Rosen MJ, Mangura BT, Hopewell PC. Bacterial pneumonia in persons infected with the human immunodeficiency virus. Pulmonary Complications of HIV Infection Study Group. N Engl J Med. 1995 Sep 28;333(13):845-51. doi: 10.1056/NEJM199509283331305.
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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.
Joseph A Kovacs, M.D. principal investigator
National Institutes of Health Clinical Center (CC)
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 HIV, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 5 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: stopped early, as of the sponsor's last update on 5 Apr 2018. 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 United States. 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 was stopped early. Results are not available in the source record.
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.
What does the primary outcome measure?
The sensitivity, compared to standard microbiological methods, of a customized TessArray microarray for the diagnosis of respiratory infections. (time frame: At time of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212042, which also lists 3 linked publications.
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 5 Apr 2018.