Respiratory InfectionsNCT01907659
Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections
A study testing Release of test results in people with Respiratory Infections, run by University of Rochester at 1 site in United States.
Trial summary
This trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Respiratory Infections
- What is being tested?
- Release of test results
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hospitalized with symptoms of a respiratory infection
- Age > 21 years
- Systolic Blood Pressure > 90mm Hg
- Patient or health care designee can provide written informed consent
Who cannot join
- Intensive Care Requirement
- Antibiotics received prior to admission
- More than 24 hours of antibiotics received prior to enrollment
- Active chemotherapy or pulmonary radiation therapy
- Immunosuppressive conditions
- Conditions know to increase PCT values
- Definite infiltrate on CXR •% of band forms in peripheral blood > 15
Trial locations and contacts
1 site in 1 country.
United States1 site
Rochester General Hospital
Rochester, New York, 14621
About this study
This trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined.
Read the detailed description
This is trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined. In addition, the added benefit of viral diagnosis to that of serum procalcitonin alone in reducing antibiotics will be determined. Lastly, antibiotic related complications and clinical outcomes to determine the safety of this approach at 30 days and 3 months in the standard care and intervention group will be evaluated. Analysis of the composite adverse event outcome (death, intensive care unit transfer, disease specific complications and recurrent respiratory tract infection requiring hospitalization) will serve as the principle safety analysis for the study. In addition, each adverse outcome will be examined individually as well as lesser adverse outcomes including antibiotic prescriptions, time to return to baseline health, patient reported outcomes and functional status at 30 days and 3 months. Physicians will be queried to determine factors which drive antibiotic prescriptions and potential barriers to implementing antibiotic reduction algorithms. These data will be used to design a phase III clinical trial with the intent to demonstrate that physicians in the US will respond appropriately to this information and that antibiotic use can be significantly and safely curtailed.
- Conditions
- Respiratory Infections
- Being tested
- Release of test results
- Keywords
- Respiratory, Viruses, Bacterial, Antibiotics, Procalcitonin
- Medical subject headings
- Respiratory Tract Infections, Virus Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Release of test resultsOther
Also called Viral PCR, Serum Procalcitonin
Subjects will be randomized to have viral testing and serum PCT results released or no additional testing performed other than that ordered as standard of care
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Standard of care for respiratory infections |
| Release of test results | Experimental | Health care providers will receive viral PCR and PCT test results along with an algorithm recommending antibiotic treatment based on PCT level. Receives: Other: Release of test results |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic days
The primary patient-level outcome is the number of days on antibiotics after randomization. The primary null hypothesis is that the distribution of the number of days on antibiotics is identical for the standard-of-care versus intervention arm, where the latter includes those patients for whom the PCT-intervention recommendation was overruled by the care team.
Measured: Total antibiotic days within 30 days after randomization
Secondary outcomes (1)
Composite adverse events at 30 days and 3 months
The secondary analyses will compare the following outcome variables between the intervention and the standard care group. Outcome variables will include total antibiotic related complications, length of hospitalization, a composite of 30 day and 3 month adverse events (death, ICU transfer, disease specific complications [development of pneumonia, lung abscess, empyema or ARDS] and recurrent LRTI requiring hospitalization).
Measured: 30 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startOct 2013
- Primary completionJun 2014
- Study completionJun 2014
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 Respiratory InfectionsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Rochester General Hospital
- Responsible party
- Principal investigator, Ann Falsey, University of Rochester
- Investigators
- Ann R Falsey, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907659
- Sponsor's protocol ID
- ABX RED-001
- Other IDs
- RGH KIDD-001
- Status last verified
- Jun 2014
- First submitted
- 27 Jun 2013
- Last updated
- 2 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Branche AR, Walsh EE, Vargas R, Hulbert B, Formica MA, Baran A, Peterson DR, Falsey AR. Serum Procalcitonin Measurement and Viral Testing to Guide Antibiotic Use for Respiratory Infections in Hospitalized Adults: A Randomized Controlled Trial. J Infect Dis. 2015 Dec 1;212(11):1692-700. doi: 10.1093/infdis/jiv252. Epub 2015 Apr 24.
PubMed 25910632
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viral Testing and Biomarkers to Reduce Antibiotic Use for Respiratory Infections
- ClinicalTrials.gov ID
- NCT01907659
- Acronym / sponsor ID
- ABX RED-001
- Conditions
- Respiratory Infections
- Keywords
- Respiratory, Viruses, Bacterial, Antibiotics, Procalcitonin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Rochester General Hospital
- Study start
- Oct 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 25 Jul 2013 (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 trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined.
Detailed description
This is trial is a pilot study to determine the feasibility of a randomized clinical trial comparing a treatment algorithm consisting of a limited number of clinical parameters, rapid molecular viral diagnostics, and serum procalcitonin testing to standard of care for directing antibiotic use in patients with non-pneumonic lower respiratory tract infection. The reduction in antibiotic use in those subjects randomized to the treatment algorithm compared to those randomized to standard care will be determined. In addition, the added benefit of viral diagnosis to that of serum procalcitonin alone in reducing antibiotics will be determined. Lastly, antibiotic related complications and clinical outcomes to determine the safety of this approach at 30 days and 3 months in the standard care and intervention group will be evaluated. Analysis of the composite adverse event outcome (death, intensive care unit transfer, disease specific complications and recurrent respiratory tract infection requiring hospitalization) will serve as the principle safety analysis for the study. In addition, each adverse outcome will be examined individually as well as lesser adverse outcomes including antibiotic prescriptions, time to return to baseline health, patient reported outcomes and functional status at 30 days and 3 months. Physicians will be queried to determine factors which drive antibiotic prescriptions and potential barriers to implementing antibiotic reduction algorithms. These data will be used to design a phase III clinical trial with the intent to demonstrate that physicians in the US will respond appropriately to this information and that antibiotic use can be significantly and safely curtailed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Standard of care for respiratory infections |
| Release of test results | Experimental | Other: Release of test resultsHealth care providers will receive viral PCR and PCT test results along with an algorithm recommending antibiotic treatment based on PCT level. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hospitalized with symptoms of a respiratory infection
- Age > 21 years
- Systolic Blood Pressure > 90mm Hg
- Patient or health care designee can provide written informed consent
Key exclusion criteria (7 listed)
- Intensive Care Requirement
- Antibiotics received prior to admission
- More than 24 hours of antibiotics received prior to enrollment
- Active chemotherapy or pulmonary radiation therapy
- Immunosuppressive conditions
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 |
|---|---|---|
| Release of test resultsAlso: Viral PCR, Serum ProcalcitoninSubjects will be randomized to have viral testing and serum PCT results released or no additional testing performed other than that ordered as standard of care | Other | Release of test results |
Primary outcome
Antibiotic days
Time frame: Total antibiotic days within 30 days after randomization
The primary patient-level outcome is the number of days on antibiotics after randomization. The primary null hypothesis is that the distribution of the number of days on antibiotics is identical for the standard-of-care versus intervention arm, where the latter includes those patients for whom the PCT-intervention recommendation was overruled by the care team.
1 secondary outcome
Composite adverse events at 30 days and 3 months
Time frame: 30 days and 3 months
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 2 Jul 2014.
- Derived from this study: PubMed 25910632Branche AR, Walsh EE, Vargas R, Hulbert B, Formica MA, Baran A, Peterson DR, Falsey AR. Serum Procalcitonin Measurement and Viral Testing to Guide Antibiotic Use for Respiratory Infections in Hospitalized Adults: A Randomized Controlled Trial. J Infect Dis. 2015 Dec 1;212(11):1692-700. doi: 10.1093/infdis/jiv252. Epub 2015 Apr 24.
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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.
Ann R Falsey, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Release of test results in people with Respiratory Infections, run by University of Rochester 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 4 inclusion and 7 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 2 Jul 2014. 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 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.
What does the primary outcome measure?
Antibiotic days (time frame: Total antibiotic days within 30 days after randomization). 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 NCT01907659, 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 2 Jul 2014.