Antimicrobial StewardshipPOCT-PCTNCT05380869
POCT PCT in Outpatient LRTI
A study testing Point-of-care Test in people with Antimicrobial Stewardship and Exacerbation of Allergic Asthma, run by Hannover Medical School at 1 site in Germany.
Trial summary
Lower respiratory tract infections (LRTI) in patients with chronic lung diseases are a common acute reason to consult respiratory practitioners and often lead to inadequate prescription of antibiotics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial Stewardship, Exacerbation of Allergic Asthma, Exacerbation Copd
- What is being tested?
- Point-of-care Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2020to 30 Apr 2021
- 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
- Clinical diagnosis of lower respiratory tract infection
Who cannot join
- Active malignancies
- Cystic fibrosis
- Solid organ or stem cell transplantation
- Chronic infection (endocarditis, osteomyelitis, active tuberculosis)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Point-of-care Procalcitonin Testing for Lower Respiratory Tract Infection in Outpatient Care
Lower respiratory tract infections (LRTI) in patients with chronic lung diseases are a common acute reason to consult respiratory practitioners and often lead to inadequate prescription of antibiotics. The primary objective of the investigators study was to determine the diagnostic accuracy of point-of-care testing (POCT) for procalcitonin (PCT) in identifying pneumonia as a bacterial infection in outpatients with LRTI.
Read the detailed description
Lower respiratory tract infections (LRTI) are a common acute reason to consult general practitioners or lung specialists and most patients receive an antibiotic prescription. Despite the vast majority of LRTI are caused by viruses, the lack of clinical, radiological, and laboratory tests to safely rule out bacterial involvement in LRTI still drives antibiotic treatment today Procalcitonin (PCT) has been shown to be a useful biomarker for differentiating between viral and bacterial infections in the emergency department and is now available as a point-of-care testing (POCT). The primary objective of the investigators study was to determine the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI. All patients aged 18 years or older with signs and symptoms of an LRTI as the leading diagnosis of the respiratory physicians are eligible. The medical assistant measure PCT from venous or capillary whole blood using the portable commercially available BRAHMS PCT direct point-of-care test (Thermo-Fischer Scientific). The stepwise procedure involve pipetting 20µl of the sample into the test disc before loading this onto the analyzer and pressing run. This immunoassay provides a quantitative result in 20 minutes. In suspicion of pneumonia (positive auscultation finding or clinical noticed symptoms compatible with pneumonia) a chest x-ray will be done. Members of the study team conduct standardised phone interviews of all participants on day 28.
- Conditions
- Antimicrobial Stewardship, Exacerbation of Allergic Asthma, Exacerbation Copd, Community-acquired Pneumonia, Lower Respiratory Tract and Lung Infections
- Being tested
- Point-of-care Test
- Keywords
- Procalcitonin, Point-of-care-Testing, Antimicrobial stewardship
- 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 TestDiagnostic test
to test Point-of-care procalcitonin in suspected pneumonia
| Study group | Role | What they receive |
|---|---|---|
| Point-of-care test Procalcitonin for LRTI | Other | Diagnostic study, a POCT-PCT is done in all included patients Receives: Diagnostic Test: Point-of-care Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of outpatients with lower respiratory tract infection
The study population will be described in terms of demographic characteristics using descriptive statistics.
Measured: up to 5 weeks
Determining the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI using portable commercially available BRAHMS PCT direct point-of-care test.
For the diagnostic accuracy of the PCT the receiver operating characteristic (ROC) curves and the area under the curve (AUC) will be calculated.
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Apr 2020
- Primary completion31 Mar 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial StewardshipStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Diagnostic study
- Masking
- None (open label)
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05380869
- Sponsor's protocol ID
- 8736_MPG_23b2019
- Acronym
- POCT-PCT
- Status last verified
- Apr 2022
- First submitted
- 12 Apr 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-care Procalcitonin Testing for Lower Respiratory Tract Infection in Outpatient Care
- ClinicalTrials.gov ID
- NCT05380869
- Acronym / sponsor ID
- POCT-PCT / 8736_MPG_23b2019
- Conditions
- Antimicrobial Stewardship, Exacerbation of Allergic Asthma, Exacerbation Copd, Community-acquired Pneumonia, Lower Respiratory Tract and Lung Infections
- Keywords
- Procalcitonin, Point-of-care-Testing, Antimicrobial stewardship
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 19 May 2022 (actual)
- 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.
Lower respiratory tract infections (LRTI) in patients with chronic lung diseases are a common acute reason to consult respiratory practitioners and often lead to inadequate prescription of antibiotics. The primary objective of the investigators study was to determine the diagnostic accuracy of point-of-care testing (POCT) for procalcitonin (PCT) in identifying pneumonia as a bacterial infection in outpatients with LRTI.
Detailed description
Lower respiratory tract infections (LRTI) are a common acute reason to consult general practitioners or lung specialists and most patients receive an antibiotic prescription. Despite the vast majority of LRTI are caused by viruses, the lack of clinical, radiological, and laboratory tests to safely rule out bacterial involvement in LRTI still drives antibiotic treatment today Procalcitonin (PCT) has been shown to be a useful biomarker for differentiating between viral and bacterial infections in the emergency department and is now available as a point-of-care testing (POCT). The primary objective of the investigators study was to determine the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI. All patients aged 18 years or older with signs and symptoms of an LRTI as the leading diagnosis of the respiratory physicians are eligible. The medical assistant measure PCT from venous or capillary whole blood using the portable commercially available BRAHMS PCT direct point-of-care test (Thermo-Fischer Scientific). The stepwise procedure involve pipetting 20µl of the sample into the test disc before loading this onto the analyzer and pressing run. This immunoassay provides a quantitative result in 20 minutes. In suspicion of pneumonia (positive auscultation finding or clinical noticed symptoms compatible with pneumonia) a chest x-ray will be done. Members of the study team conduct standardised phone interviews of all participants on day 28.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Diagnostic study
| Arm | Type | Receives |
|---|---|---|
| Point-of-care test Procalcitonin for LRTI | Other | Diagnostic Test: Point-of-care TestDiagnostic study, a POCT-PCT is done in all included patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years or older
- Clinical diagnosis of lower respiratory tract infection
Key exclusion criteria (5 listed)
- Active malignancies
- Cystic fibrosis
- Solid organ or stem cell transplantation
- Chronic infection (endocarditis, osteomyelitis, active tuberculosis)
- Pregnancy
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 Testto test Point-of-care procalcitonin in suspected pneumonia | Diagnostic test | Point-of-care test Procalcitonin for LRTI |
Primary outcome
Description of outpatients with lower respiratory tract infection
Time frame: up to 5 weeks
The study population will be described in terms of demographic characteristics using descriptive statistics.
Determining the diagnostic accuracy of POCT PCT in identifying bacterial infection in outpatients with LRTI using portable commercially available BRAHMS PCT direct point-of-care test.
Time frame: up to 5 weeks
For the diagnostic accuracy of the PCT the receiver operating characteristic (ROC) curves and the area under the curve (AUC) will be calculated.
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 19 May 2022.
- Individual participant dataSharing planned: No
Related trials for Antimicrobial Stewardship
RecruitingObservational study
Evidence Based QUality Improvement for Prescribing Stewardship in ICU (EQUIPS-ICU)
Antimicrobial Stewardship
Recruiting
Molecular Microbiology- Guided Antimicrobial Stewardship Versus Standard Stewardship in Hospitalized Patients
Infection, Antimicrobial Stewardship Program
Active, not recruiting
Digital Otoscopy Versus Standard Otoscopy on the Diagnosis and Treatment of Otitis Media in Young Children
Otitis Media, Antimicrobial Stewardship
Recruiting
Optimal Implementation of Antimicrobial Stewardship in General Practice
The Use of Antimicrobial Stewardship in in General Practice (Family Medicine), Respiratory Tract Infections (RTI)
Enrolling by invitation
Peer Comparison Feedback As An Antimicrobial Prescribing Intervention To General Medicine Specialists
Antimicrobial Stewardship, Antimicrobial Drug Resistance
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 Point-of-care Test in people with Antimicrobial Stewardship and Exacerbation of Allergic Asthma, run by Hannover Medical School at 1 site in Germany.
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 2 inclusion and 5 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 19 May 2022. 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 Germany. 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?
Description of outpatients with lower respiratory tract infection (time frame: up to 5 weeks). The study lists 2 primary outcomes in all. 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 May 2022; AzTrials last refreshed its copy on 6 Nov 2026.