Pneumonia, PneumococcalCAPTAINNCT03315403
Quantitative Polymerase Chain Reaction for Improved Detection of Pneumococci in CAP "CAPTAIN"
An observational study of Pneumonia, Pneumococcal and Community-acquired Pneumonia, run by Medical Center Alkmaar at 2 sites in Netherlands.
Trial summary
The purpose of this study is to evaluate the added diagnostic value of a quantitative polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with community-acquired pneumonia. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pneumonia, Pneumococcal, Community-acquired Pneumonia
- What is being tested?
- LytA targeted quantitative polymerase chain reaction (qPCR)
- How many people
- 922 participants
- Where
- 2 sitesNetherlands
- Study dates
- 5 Apr 2018to 12 Mar 2020
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient group: Adult patients ≥18 years with diagnosis of CAP at the emergency department (ED). Control groups (without CAP): * Related controls (inclusion at ED) * Unrelated healthy adults (inclusion at an outpatient preoperative appointment for any elective surgery) * Stable COPD patients (inclusion at outpatient clinic for pulmonary diseases) * COPD patients with an AECOPD (inclusion at ED)
Who may be able to join
- Patients:
- Age 18 years or above;
- Presentation at the emergency department (ED);
- Working diagnosis of CAP at the ED with the presence of at least two of the following criteria:
- New or worsened coughing;
- Production of purulent sputum or change in sputum colour;
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- Temperature >38.0 ⁰C or ≤36.0 ⁰C (tympanic);
- Auscultatory findings consistent with pneumonia, including rales, evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, rales, or egophony), or both;
- White blood cell count of >10x10^9 cells/L or <4x10^9 cells/L or >15% bands;
- C-reactive protein level ≥30mg/L;
- Dyspnea, tachypnea, (>20 breaths per minute), or hypoxemia (arterial pO2 <60mmHg or peripheral O2 saturation <90%).
- New consolidation(s) on the chest radiograph or computed tomography (CT);
- No other explanation for the signs and symptoms;
- Control group 1 - Related controls
- Being aged 18 years or above;
- Close relative of the patient: relative defined as living in the same house as the CAP patient or daily contact;
- Is at the hospital at the moment of inclusion of the CAP patient or is willing to come for testing within 7 days;
- Control group 2 - Unrelated healthy individuals
- Being aged 18 years or above;
- Subject with a preoperative appointment with the anaesthiologist for a planned surgical procedure;
- Age matched to a included CAP patient (+-10 years);
- Time matched to a included CAP patient (up to 14 days after inclusion of the CAP patient);
- Gender matched to a included CAP patient.
- Control group 3 - Patients with stable COPD
- Being aged 18 years or above;
- Diagnosis of COPD confirmed with spirometry (GOLD criteria 2017)(76);
- Stable disease.
- Control group 4 - Patients with exacerbation of COPD
- Being aged 18 years or above;
- Diagnosis of COPD confirmed with spirometry (GOLD criteria 2017)(76);
- Diagnosis of exacerbation of COPD: defined as an acute event characterised by a worsening of the patient's respiratory symptoms that is beyond normal day-to-day variations and leads to a change in medication (76).
- Presentation at emergency department with the suspicion of an exacerbation.
Who cannot join
- In general:
- Recent pneumonia (< 1 month) or pneumonia in last 3 months with known pneumococcal aetiology with one of current diagnostics;
- Was included in the study group before;
- Not capable of understanding information needed to sign informed consent.
- Patients:
- Aspiration pneumonia;
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- Hospitalisation for two or more days in the last 14 days;
- History of cystic fibrosis.
- For all control groups:
- Fits inclusion criteria for patient group;
- Present or recent hospitalisation (14 days);
- Fits inclusion criteria for patient group;
- Use of antibiotics in the last 14 days, including maintenance antibiotic therapy.
- Control group 1 and 2 - Related healthy controls and unrelated healthy individuals
- Active infectious respiratory complaints defined as defined as two or more respiratory symptoms (cough, nasal congestion, runny nose, sore throat or sneezes);
- Temperature >38.0 ⁰C;
- Fits inclusion criteria for control group 3 or 4;
- Chronic pulmonary disease: COPD, asthma, cystic fibrosis, bronchiectasis.
- Control group 3 - Patients with stable COPD
- Temperature >38.0 ⁰C;
- Stable disease;
- Fits inclusion criteria for control group 4;
- Recent exacerbation (<1 month) defined as increased respiratory symptoms with need of antibiotic and/or corticosteroid therapy;
- History of cystic fibrosis.
- Control group 4 - Patients with exacerbation of COPD
- Current pneumonia;
- Recent exacerbation (<1 month) defined as increased respiratory symptoms with need of antibiotic and/or corticosteroid therapy;
- Fits inclusion criteria for control group 3;
- History of cystic fibrosis.
Trial locations and contacts
2 sites in 1 country.
Netherlands2 sites
Noordwest Ziekenhuisgroep
Alkmaar
Spaarne Gasthuis
Haarlem, North Holland
About this study
Official title: Community-Acquired Pneumonia: lytA TArgeted Real Time Quantitative Polymerase chaIN Reaction for Improved Detection of Pneumococci (CAPTAIN)
The purpose of this study is to evaluate the added diagnostic value of a quantitative polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with community-acquired pneumonia.
- Being tested
- LytA targeted quantitative polymerase chain reaction (qPCR)
- Keywords
- quantitative polymerase chain reaction, qPCR, autolysin, lytA, Pneumococcal pneumonia, Diagnostics, Community-acquired Pneumonia, Antibiotic resistance
- Medical subject headings
- Pneumonia, Pneumococcal, Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LytA targeted quantitative polymerase chain reaction (qPCR)Diagnostic test
LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)
| Study group | Role | What they receive |
|---|---|---|
| Patients with CAP | Patients with a diagnosis of radiographically-confirmed CAP at the emergency department will undergo the usual diagnostics. For the study an extra nasopharynx sample, saliva sample and blood sample will be collected.
A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) Receives: Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR) | |
| Related controls | Of related controls a nasopharynx sample, oropharynx sample and saliva sample will be collected.
A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva) Receives: Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR) | |
| Unrelated controls | Of unrelated controls a nasopharynx sample, oropharynx sample and saliva sample will be collected.
A questionnaire will be filled in. LytA PCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva) Receives: Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR) | |
| Patients with stable COPD | Of stable COPD patients a nasopharynx sample, oropharynx sample and saliva sample will be collected. And if available also a sputum sample.
A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) Receives: Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR) | |
| Patients with exacerbation of COPD | Of patients with a diagnosis of an exacerbation of COPD at the emergency department a nasopharynx sample, oropharynx sample and saliva sample will be collected apart from the usual diagnostics. If available also a sputum sample will be collected.
A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) Receives: Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
qPCR diagnosed pneumococcal pneumonia
Occurrence of qPCR proven pneumococcal pneumonia (CAP with S. pneumoniae detected by qPCR in at least one of the samples with a positive lytA qPCR and a DNA copy number above the determined cut-off value) using the cut-off value in at least one of the specimens at inclusion. The cut-off value will be determined in this study, see secondary objective.
Measured: 1 day, day of inclusion
Pneumococcal pneumonia with usual tests
Occurrence of pneumococcal pneumonia proven by at least one of the routine microbiological tests (urine antigen test, blood culture and/or sputum culture). The difference between outcome measure 1 and 2 is the added diagnostic value.
Measured: 1 day, day of inclusion
Secondary outcomes (4)
Number of DNA copies of S. pneumoniae in all lytA qPCR positive study subjects
The number of DNA copies of every study subject with a positive qPCR will be determined. The optimal cut-off value will be determined to distinguish between colonisation and infection by comparing the number of DNA copies of controls with a positive lytA PCR and patients with a pneumococcal pneumonia proven by routine microbiological tests. This cut-off value will be used for outcome measure 1 to determine the amount of patients with an qPCR proven pneumococcal pneumonia.
Measured: 1 day, day of inclusion
Occurrence of positive lytA qPCR at 30 days after inclusion in CAP patients
Occurrence of positive lytA qPCR at 30 days after inclusion in CAP patients in the different samples: oropharynx, nasopharynx, saliva and sputum.
Measured: 30 days
CURB-65 scores
CURB-65 scores will be determined in CAP patients at moment of inclusion.
Measured: 1 day, day of inclusion
Procalcitonin
Procalcitonin levels will be determined in CAP patients at moment of inclusion.
Measured: 1 day, day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start5 Apr 2018
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumonia, PneumococcalStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 922 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Center Alkmaar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W.G.Boersma, Medical Center Alkmaar
- Investigators
- Wim Boersma, MD. PhD., Principal investigator, Noordwest Ziekenhuisgroep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315403
- Sponsor's protocol ID
- 63200
- Acronym
- CAPTAIN
- Status last verified
- Apr 2022
- First submitted
- 3 Oct 2017
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-Acquired Pneumonia: lytA TArgeted Real Time Quantitative Polymerase chaIN Reaction for Improved Detection of Pneumococci (CAPTAIN)
- ClinicalTrials.gov ID
- NCT03315403
- Acronym / sponsor ID
- CAPTAIN / 63200
- Keywords
- quantitative polymerase chain reaction, qPCR, autolysin, lytA, Pneumococcal pneumonia, Diagnostics, Community-acquired Pneumonia, Antibiotic resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 922 participants (actual)
- Lead sponsor
- Medical Center AlkmaarUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 20 Oct 2017 (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.
The purpose of this study is to evaluate the added diagnostic value of a quantitative polymerase chain reaction targeting the lytA gene in detecting pneumococci in patients with community-acquired pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Patients with CAP | – | Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)Patients with a diagnosis of radiographically-confirmed CAP at the emergency department will undergo the usual diagnostics. For the study an extra nasopharynx sample, saliva sample and blood sample will be collected. A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) |
| Related controls | – | Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)Of related controls a nasopharynx sample, oropharynx sample and saliva sample will be collected. A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva) |
| Unrelated controls | – | Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)Of unrelated controls a nasopharynx sample, oropharynx sample and saliva sample will be collected. A questionnaire will be filled in. LytA PCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva) |
| Patients with stable COPD | – | Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)Of stable COPD patients a nasopharynx sample, oropharynx sample and saliva sample will be collected. And if available also a sputum sample. A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) |
| Patients with exacerbation of COPD | – | Diagnostic Test: LytA targeted quantitative polymerase chain reaction (qPCR)Of patients with a diagnosis of an exacerbation of COPD at the emergency department a nasopharynx sample, oropharynx sample and saliva sample will be collected apart from the usual diagnostics. If available also a sputum sample will be collected. A questionnaire will be filled in. LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient group: Adult patients ≥18 years with diagnosis of CAP at the emergency department (ED). Control groups (without CAP): * Related controls (inclusion at ED) * Unrelated healthy adults (inclusion at an outpatient preoperative appointment for any elective surgery) * Stable COPD patients (inclusion at outpatient clinic for pulmonary diseases) * COPD patients with an AECOPD (inclusion at ED)
Key inclusion criteria (32 listed)
- Age 18 years or above;
- Presentation at the emergency department (ED);
- Working diagnosis of CAP at the ED with the presence of at least two of the following criteria:
- New consolidation(s) on the chest radiograph or computed tomography (CT);
- No other explanation for the signs and symptoms;
Key exclusion criteria (29 listed)
- Recent pneumonia (< 1 month) or pneumonia in last 3 months with known pneumococcal aetiology with one of current diagnostics;
- Was included in the study group before;
- Not capable of understanding information needed to sign informed consent.
- Aspiration pneumonia;
- Hospitalisation for two or more days in the last 14 days;
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 |
|---|---|---|
| LytA targeted quantitative polymerase chain reaction (qPCR)LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available) | Diagnostic test | Patients with CAP, Patients with exacerbation of COPD, Patients with stable COPD, Related controls, Unrelated controls |
Primary outcome
qPCR diagnosed pneumococcal pneumonia
Time frame: 1 day, day of inclusion
Occurrence of qPCR proven pneumococcal pneumonia (CAP with S. pneumoniae detected by qPCR in at least one of the samples with a positive lytA qPCR and a DNA copy number above the determined cut-off value) using the cut-off value in at least one of the specimens at inclusion. The cut-off value will be determined in this study, see secondary objective.
Pneumococcal pneumonia with usual tests
Time frame: 1 day, day of inclusion
Occurrence of pneumococcal pneumonia proven by at least one of the routine microbiological tests (urine antigen test, blood culture and/or sputum culture). The difference between outcome measure 1 and 2 is the added diagnostic value.
4 secondary outcomes
Number of DNA copies of S. pneumoniae in all lytA qPCR positive study subjects
Time frame: 1 day, day of inclusion
Occurrence of positive lytA qPCR at 30 days after inclusion in CAP patients
Time frame: 30 days
CURB-65 scores
Time frame: 1 day, day of inclusion
Procalcitonin
Time frame: 1 day, day of inclusion
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 8 Apr 2022.
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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.
Wim Boersma, MD. PhD. principal investigator
Noordwest Ziekenhuisgroep
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumonia, Pneumococcal and Community-acquired Pneumonia, run by Medical Center Alkmaar at 2 sites in Netherlands.
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 32 inclusion and 29 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 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. 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?
qPCR diagnosed pneumococcal pneumonia (time frame: 1 day, day of inclusion). 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 8 Apr 2022.