Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe: GRACE Workpackage 9: Study on the aetiology, diagnosis and prognosis of lower respiratory tract infections in primary care

Genomics to combat Resistance against Antibiotics in Community-acquired LRTI in Europe: GRACE Workpackage 9: Study on the aetiology, diagnosis and prognosis of lower respiratory tract infections in primary care - GRACE WP9

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33556

Enrollment

600

Registered

2007-10-16

Start date

2007-11-26

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cough Lower Respiratory Tract Infections (LRTI)

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Aged 18 years to 60 years and 60 years and over (enrolment will be done in such a way that 1500 patients under 60 and 1500 patients of 60 years and older will be included) - Consulting with acute cough as the main symptom (up to and including 28 days duration) or those in whom the general practitioner suspects the presence of acute lower respiratory tract infection - Who is immuno-competent (no serious immunological deficiencies) - Who have provided written, informed consent to participate - Who has not been on antibiotic treatment in the previous month - Not pregnant

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
1. Outcome parameters of the aetiological study will be the results of the microbiological tests, including information on bacterial resistance. 2. Outcome measurements of the diagnostic study will be the presence of pneumonia, confirmed by specified findings on a chest X ray and the presence of a bacterial infection. A bacterial infection is defined either by the isolation of a predominant bacterial organism from a purulent sputum (25 polymorphonuclear leucocytes or less, 10 squamous epithelial cells or more per low power field) with a compatible predominant (+75%) morphotype on a Gram stain or from a nasopharynfeal aspirate, or by the detection by non-culture techniques e.g. PCR of the atypical agents Mycoplasma pneumoniae, Chlamydia pneumoniae , Legionella pneumophila. 3. Outcome parameter of the prognostic study will be significant deterioration of illness - which is defined as a re-visit to a clinician with worsening symptoms, new symptoms, new signs, or requiring admission to hospital within four weeks after the first consultation: this includes pneumonia following uncomplicated community-acquired LRTI, sepsis, acute cerebrovascular and cardiovascular disease, exacerbations of concomitant high-risk disease, or death.	—

Measure

Time frame

1. Outcome parameters of the aetiological study will be the results of the microbiological tests, including information on bacterial resistance. 2. Outcome measurements of the diagnostic study will be the presence of pneumonia, confirmed by specified findings on a chest X ray and the presence of a bacterial infection. A bacterial infection is defined either by the isolation of a predominant bacterial organism from a purulent sputum (25 polymorphonuclear leucocytes or less, 10 squamous epithelial cells or more per low power field) with a compatible predominant (+75%) morphotype on a Gram stain or from a nasopharynfeal aspirate, or by the detection by non-culture techniques e.g. PCR of the atypical agents Mycoplasma pneumoniae, Chlamydia pneumoniae , Legionella pneumophila. 3. Outcome parameter of the prognostic study will be significant deterioration of illness - which is defined as a re-visit to a clinician with worsening symptoms, new symptoms, new signs, or requiring admission to hospital within four weeks after the first consultation: this includes pneumonia following uncomplicated community-acquired LRTI, sepsis, acute cerebrovascular and cardiovascular disease, exacerbations of concomitant high-risk disease, or death.

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Countries

Netherlands

Outcome results