Community-acquired PneumoniaNIHCAPNCT01662258
Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For CAP
A study testing Point-of-Care diagnostic laboratory test in people with Community-acquired Pneumonia, run by University of Pittsburgh at 5 sites in United States.
Trial summary
This is a prospective interventional study to assess laboratory testing which will identify the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent selection for patients with community acquired-pneumonia (CAP). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Community-acquired Pneumonia
- What is being tested?
- Point-of-Care diagnostic laboratory test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Oct 2012to Aug 2013
- Phase
- Interventional
- 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
Who may be able to join
- ● Adult patients greater than age 17 years who are initially evaluated in the ED with symptoms of CAP. This includes those who will be treated as outpatients and those admitted to the hospital (both ward and ICU).
- The definition of CAP is as follows:
- Presence of pulmonary infiltrates on chest radiography. (Initial reading may be performed by the ED physician - but has to be confirmed by board certified radiologist for inclusion in the study).
- At least 2 of the following: new onset of cough, productive sputum, shortness of breath, chest pain, fever > 380C, abnormal chest auscultation, WBC > 12,000 cells/mL.
- Able to provide informed consent
- Read, signed, and dated informed consent document
- Available for follow-up for the planned duration of the study
Who cannot join
- Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia, transplant recipient, cystic fibrosis, receipt of immunosuppressive medications including corticosteroids, (equivalent of prednisone > 10 mg) cancer chemotherapy, or anti-tumor necrosis factor agents.
- Patients residing in long-term care facilities
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Summa Health System
Akron, Ohio, 44304
Johns Hopkins
Baltimore, Maryland, 21287
Baylor College of Medicine
Houston, Texas, 77030
University of Louisville
Louisville, Kentucky, 40202
Beth Israel
New York, New York, 10003
About this study
Official title: Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia
This is a prospective interventional study to assess laboratory testing which will identify the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent selection for patients with community acquired-pneumonia (CAP).
Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to Empiric therapy in patients with viral pneumonia
Read the detailed description
The study will be conducted at five academic medical university sites with 7 hospitals. Empiric therapy is defined as selection of antibiotic therapy based on the 2007 ATS-IDSA guidelines in which broad-spectrum antibiotics are recommended, and microbial cause is uncertain
- Conditions
- Community-acquired Pneumonia
- Being tested
- Point-of-Care diagnostic laboratory test
- Keywords
- Community-acquired pneumonia, Targeted strategy, Empiric therapy
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-Care diagnostic laboratory testDevice
Also called The POC tests are:, FilmArray (Idaho Tech, Salt Lake City, UT), Xpert Flu (Cepheid, Sunnyvale, CA), Vidas Brahms Procalcitonin (BioMerieux, Durham, NC)
All POC tests are FDA-cleared.
| Study group | Role | What they receive |
|---|---|---|
| Point-of-Care diagnostic laboratory test | Experimental | Adult patients with community-acquired pneumonia (CAP) who are in the Targeted strategy group will undergo point-of-care (POC) diagnostic laboratory tests. Receives: Device: Point-of-Care diagnostic laboratory test |
| Empiric therapy | No intervention | Option of no application of POC laboratory tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration
Symptoms of sputum, cough, shortness of breath. Objective signs of deterioration: Acute Respiratory Distress Syndrome, empyema,nonpulmonary infection by infecting microbe, ICU admission, rehospitalization within 7 days following discharge
Measured: 30 days after enrollment
Secondary outcomes (1)
Identification of microbial etiology by laboratory testing
POC microbiology testing including gram stain of respiratory secretions, blood culture, molecular probes.
Measured: 30 days following enrollment, although microbial identification usually occurs within 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startOct 2012
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: Decision by NIH
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired PneumoniaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of Louisville, Louisville VA Medical Center, Johns Hopkins University, Summa Health System, Baylor College of Medicine, Ben Taub Hospital, Michael E. DeBakey VA Medical Center, Beth Israel Medical Center
- Responsible party
- Sponsor
- Investigators
- Victor L Yu, M.D., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662258
- Sponsor's protocol ID
- HHSN272201000040C
- Acronym
- NIHCAP
- Status last verified
- Apr 2016
- First submitted
- 3 Aug 2012
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiology Testing With the Aim Of Directed Antimicrobial Therapy For Community-Acquired Pneumonia
- ClinicalTrials.gov ID
- NCT01662258
- Acronym / sponsor ID
- NIHCAP / HHSN272201000040C
- Conditions
- Community-acquired Pneumonia
- Keywords
- Community-acquired pneumonia, Targeted strategy, Empiric therapy
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Decision by NIH
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of Louisville, Louisville VA Medical Center, Johns Hopkins University, Summa Health System, Baylor College of Medicine, Ben Taub Hospital, Michael E. DeBakey VA Medical Center, Beth Israel Medical Center
- Study start
- Oct 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Aug 2012 (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.
This is a prospective interventional study to assess laboratory testing which will identify the microbial cause of pneumonia. This, in turn, will allow targeted antimicrobial agent selection for patients with community acquired-pneumonia (CAP).
Hypothesis: 1) To determine if Targeted strategy is non-inferior to Empiric therapy with respect to outcome endpoints. 2) To assess the use of innovative POC tests allows targeted narrow-spectrum antimicrobial therapy. 3) To determine if Targeted strategy is superior to Empiric therapy in patients with viral pneumonia
Detailed description
The study will be conducted at five academic medical university sites with 7 hospitals. Empiric therapy is defined as selection of antibiotic therapy based on the 2007 ATS-IDSA guidelines in which broad-spectrum antibiotics are recommended, and microbial cause is uncertain
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Point-of-Care diagnostic laboratory test | Experimental | Device: Point-of-Care diagnostic laboratory testAdult patients with community-acquired pneumonia (CAP) who are in the Targeted strategy group will undergo point-of-care (POC) diagnostic laboratory tests. |
| Empiric therapy | No intervention | –Option of no application of POC laboratory tests |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ● Adult patients greater than age 17 years who are initially evaluated in the ED with symptoms of CAP. This includes those who will be treated as outpatients and those admitted to the hospital (both ward and ICU).
- Presence of pulmonary infiltrates on chest radiography. (Initial reading may be performed by the ED physician - but has to be confirmed by board certified radiologist for inclusion in the study).
- At least 2 of the following: new onset of cough, productive sputum, shortness of breath, chest pain, fever > 380C, abnormal chest auscultation, WBC > 12,000 cells/mL.
- Able to provide informed consent
- Read, signed, and dated informed consent document
Key exclusion criteria (2 listed)
- Patients with underlying immunosuppressive illness (HIV, neutropenia, asplenia, transplant recipient, cystic fibrosis, receipt of immunosuppressive medications including corticosteroids, (equivalent of prednisone > 10 mg) cancer chemotherapy, or anti-tumor necrosis factor agents.
- Patients residing in long-term care facilities
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 |
|---|---|---|
| Point-of-Care diagnostic laboratory testAlso: The POC tests are:, FilmArray (Idaho Tech, Salt Lake City, UT), Xpert Flu (Cepheid, Sunnyvale, CA), Vidas Brahms Procalcitonin (BioMerieux, Durham, NC)All POC tests are FDA-cleared. | Device | Point-of-Care diagnostic laboratory test |
Primary outcome
Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration
Time frame: 30 days after enrollment
Symptoms of sputum, cough, shortness of breath. Objective signs of deterioration: Acute Respiratory Distress Syndrome, empyema,nonpulmonary infection by infecting microbe, ICU admission, rehospitalization within 7 days following discharge
1 secondary outcome
Identification of microbial etiology by laboratory testing
Time frame: 30 days following enrollment, although microbial identification usually occurs within 5 days.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2016.
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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.
Victor L Yu, M.D. principal investigator
University of Pittsburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-Care diagnostic laboratory test in people with Community-acquired Pneumonia, run by University of Pittsburgh at 5 sites 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 7 inclusion and 2 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: withdrawn, as of the sponsor's last update on 19 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 withdrawn before enrolling participants, so there are no results.
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?
Improvement or resolution of symptoms of CAP AND absence of objective signs of deterioration (time frame: 30 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2016.