Acute Respiratory Tract InfectionluftvagsPCRNCT01133782
Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections.
A study testing Access to diagnostic test in people with Acute Respiratory Tract Infection, run by Göteborg University at 1 site in Sweden.
Trial summary
Viral respiratory infections are common worldwide. It has been suggested that nucleic acid amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing antibiotic prescriptions rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Respiratory Tract Infection
- What is being tested?
- Access to diagnostic test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2006to Apr 2009
- 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
- Age 18 years or older
- At least two of the following symptoms: coryza, congestion, sneezing, sore throat, odynophagi, cough, chest pain, shortness of breath or fever for which teh physician found no other explanation.
- Symptom duration of less than 14 days
Who cannot join
- >14 days of symptoms
- confirmed bacterial infection
- Hospital acquired infection (>3days in hospital)
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Infectious Diseases, Sahlgrenska University Hospital
Gothenburg, se-41685
About this study
Viral respiratory infections are common worldwide. It has been suggested that nucleic acid amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing antibiotic prescriptions rates. The objective of this study was to evaluate if access to a multiplex real-time PCR method would have an impact on antibiotic prescriptions for acute respiratory tract infections (ARTIs), in primary care. Adult patients with respiratory tract infections will be prospectively included. Nasopharyngeal and throat swabs will be analyzed with a multiplex real-time PCR method, targeting 13 viruses and two bacteria. Samples will be collected during the winter season (October-April). Patients will be open-label randomised to receive a rapid result (the following day) or a delayed result (after 10+/-2 days). The investigators are planning to include approximately 400 patients. Prescription of antibiotics will be measured at initial visit as well as at a follow-up visit 10+/-2 days later. Primary endpoint is antibiotic prescription in the acute phase (initial visit) and secondary endpoint antibiotic treatment (ongoing or initiated) at follow-up visit. The hypohesis is that access to a method with the ability of providing a rapid etiologic diagnosis of respiratory infections will affect the use of antibiotics in outpatient care of adult patients with ARTI.
- Conditions
- Acute Respiratory Tract Infection
- Being tested
- Access to diagnostic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Access to diagnostic testProcedure or surgery
Randomization to receive a result of diagostic procedure the following day.
| Study group | Role | What they receive |
|---|---|---|
| Rapid result | Experimental | Result of diagnostic PCR panel provided the following day Receives: Procedure: Access to diagnostic test |
| Delayed result | No intervention | Result of dagnostic PCR panel provided within 10+/-2 days at follow-up visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibiotic treatment prescriped at initial visit
Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.
Measured: Within 2 days of initial visit
Secondary outcomes (1)
Antibiotic treatment prescribed or reported at follow-up visit
Antibiotic prescriptions at follow visit are measured as an outcome of the diagnostic procedure tested.
Measured: 10+/-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startOct 2006
- Primary completionApr 2009
- Study completionApr 2009
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 Acute Respiratory Tract InfectionStudies of the same condition, open and under way.
- More trials run by Göteborg UniversityThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Göteborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Vastra Gotaland Region, Strama - the Swedish strategic programme against antibiotic resistance., Capio Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133782
- Sponsor's protocol ID
- luftvagsPCR-01
- Acronym
- luftvagsPCR
- Status last verified
- Oct 2006
- First submitted
- 28 May 2010
- Last updated
- 31 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Brittain-Long R, Westin J, Olofsson S, Lindh M, Andersson LM. Access to a polymerase chain reaction assay method targeting 13 respiratory viruses can reduce antibiotics: a randomised, controlled trial. BMC Med. 2011 Apr 26;9:44. doi: 10.1186/1741-7015-9-44.
PubMed 21521505
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application of PCR-based Diagnosis of Community-onset Viral Respiratory Infections.
- ClinicalTrials.gov ID
- NCT01133782
- Acronym / sponsor ID
- luftvagsPCR / luftvagsPCR-01
- Conditions
- Acute Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Göteborg UniversityUniversity, hospital or other
- Collaborators
- Vastra Gotaland Region, Strama - the Swedish strategic programme against antibiotic resistance., Capio Research Foundation
- Study start
- Oct 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 31 May 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.
Viral respiratory infections are common worldwide. It has been suggested that nucleic acid amplification tests, enabling a rapid etiologic diagnosis, may be useful in reducing antibiotic prescriptions rates. The objective of this study was to evaluate if access to a multiplex real-time PCR method would have an impact on antibiotic prescriptions for acute respiratory tract infections (ARTIs), in primary care. Adult patients with respiratory tract infections will be prospectively included. Nasopharyngeal and throat swabs will be analyzed with a multiplex real-time PCR method, targeting 13 viruses and two bacteria. Samples will be collected during the winter season (October-April). Patients will be open-label randomised to receive a rapid result (the following day) or a delayed result (after 10+/-2 days). The investigators are planning to include approximately 400 patients. Prescription of antibiotics will be measured at initial visit as well as at a follow-up visit 10+/-2 days later. Primary endpoint is antibiotic prescription in the acute phase (initial visit) and secondary endpoint antibiotic treatment (ongoing or initiated) at follow-up visit. The hypohesis is that access to a method with the ability of providing a rapid etiologic diagnosis of respiratory infections will affect the use of antibiotics in outpatient care of adult patients with ARTI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rapid result | Experimental | Procedure: Access to diagnostic testResult of diagnostic PCR panel provided the following day |
| Delayed result | No intervention | –Result of dagnostic PCR panel provided within 10+/-2 days at follow-up visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 years or older
- At least two of the following symptoms: coryza, congestion, sneezing, sore throat, odynophagi, cough, chest pain, shortness of breath or fever for which teh physician found no other explanation.
- Symptom duration of less than 14 days
Key exclusion criteria (3 listed)
- >14 days of symptoms
- confirmed bacterial infection
- Hospital acquired infection (>3days in hospital)
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 |
|---|---|---|
| Access to diagnostic testRandomization to receive a result of diagostic procedure the following day. | Procedure or surgery | Rapid result |
Primary outcome
Antibiotic treatment prescriped at initial visit
Time frame: Within 2 days of initial visit
Antibiotic prescriptions are measured as an outcome of the diagnostic procedure tested.
1 secondary outcome
Antibiotic treatment prescribed or reported at follow-up visit
Time frame: 10+/-2 days
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 31 May 2010.
- Derived from this study: PubMed 21521505Brittain-Long R, Westin J, Olofsson S, Lindh M, Andersson LM. Access to a polymerase chain reaction assay method targeting 13 respiratory viruses can reduce antibiotics: a randomised, controlled trial. BMC Med. 2011 Apr 26;9:44. doi: 10.1186/1741-7015-9-44.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Access to diagnostic test in people with Acute Respiratory Tract Infection, run by Göteborg University at 1 site in Sweden.
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 3 inclusion and 3 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 31 May 2010. 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 Sweden. 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 treatment prescriped at initial visit (time frame: Within 2 days of initial visit). 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 NCT01133782, 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 31 May 2010.