Quantitative Polymerase Chain Reaction for Improved Detection of Pneumococci in CAP "CAPTAIN"

NCT ID: NCT03315403

Last Updated: 2022-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 922 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-05
• Study Completion Date: 2020-03-12

Brief 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.

Conditions

Pneumonia, Pneumococcal; Community-acquired Pneumonia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

LytA targeted quantitative polymerase chain reaction (qPCR)

Intervention Type: DIAGNOSTIC_TEST

LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)

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)

LytA targeted quantitative polymerase chain reaction (qPCR)

Intervention Type: DIAGNOSTIC_TEST

LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)

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)

LytA targeted quantitative polymerase chain reaction (qPCR)

Intervention Type: DIAGNOSTIC_TEST

LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)

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)

LytA targeted quantitative polymerase chain reaction (qPCR)

Intervention Type: DIAGNOSTIC_TEST

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

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)

LytA targeted quantitative polymerase chain reaction (qPCR)

Intervention Type: DIAGNOSTIC_TEST

LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)

Interventions

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)

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

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:

1. New or worsened coughing;

2. Production of purulent sputum or change in sputum colour;

3. Temperature >38.0 ⁰C or ≤36.0 ⁰C (tympanic);

4. Auscultatory findings consistent with pneumonia, including rales, evidence of pulmonary consolidation (dullness on percussion, bronchial breath sounds, rales, or egophony), or both;

5. White blood cell count of >10x10^9 cells/L or <4x10^9 cells/L or >15% bands;

6. C-reactive protein level ≥30mg/L;

7. 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.

• Present or recent hospitalisation (14 days);
• 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;
• Chronic pulmonary disease: COPD, asthma, cystic fibrosis, bronchiectasis.

Control group 3 - Patients with stable COPD

• Temperature >38.0 ⁰C;
• Stable disease;
• 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;
• History of cystic fibrosis.

Exclusion Criteria

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;
• Hospitalisation for two or more days in the last 14 days;
• History of cystic fibrosis.

For all control groups:

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical Center Alkmaar

OTHER

Sponsor Role: lead

Responsible Party

W.G.Boersma

MD. PhD. Pulmonologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wim Boersma, MD. PhD.

Role: PRINCIPAL_INVESTIGATOR

Noordwest Ziekenhuisgroep

Locations

Spaarne Gasthuis

Haarlem, North Holland, Netherlands

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Countries

Netherlands

Other Identifiers

63200

Identifier Type: -

Identifier Source: org_study_id