Community Acquired Pneumonia
Conditions
Brief summary
The purpose of this study is to evaluate two different treatment strategies in patients admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be effective in reducing the length of antibiotic treatment.
Interventions
DRUGDiscontinuation of treatment according to CRP levels
The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.
DRUGDiscontinuation of treatment according to PCT levels
The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.
DRUGTreatment according to current guidelines
Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.
Sponsors
Foreest Medical School
Pulmoscience
Medical Center Alkmaar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Male and female patients with a diagnosis of CAP and all criteria listed below: 1. Age 18 or above, no upper age limit will be employed. 2. Patients must require hospitalisation. 3. Clinical presentation of an acute illness with one or more of the following symptoms: 1. Temperature ≥ 38.0 ⁰C (100.4°F) 2. Dyspnoea 3. Cough (with or without expectoration of sputum) 4. Chest pain 5. Malaise or fatigue 6. Myalgia 7. Gastro-intestinal symptoms 8. Rales, rhonchi or wheezing 9. Egophony or bronchial breath sounds 4. New consolidation(s) on the chest radiograph. 5. Written informed consent obtained. 6. (Pre-event) Life expectancy \> 30 days
Exclusion criteria
Subjects presenting with any of the following will not be included in the study: 1. (Severe) immunosuppression (e.g. HIV infection, chemotherapy, use of immunosuppressants). 2. Active neoplastic disease. 3. Obstruction pneumonia (e.g. from lung cancer). 4. Aspiration pneumonia. 5. Pneumonia that developed within 8 days after hospital discharge. 6. Unable and/or unlikely to comprehend and/or follow the protocol. 7. Pregnant and/or lactating women. 8. Other infection that requires treatment with antibiotics
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Length of antibiotic treatment | End of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of stay | End of the study | — |
| Clinical response | End of the study | Cure - resolution or improvement of symptoms and clinical signs related to pneumonia without the need for additional or alternative antibiotic therapy Failure - persistence or progression of all signs and symptoms of the acute process after randomisation or the development of a new pulmonary or extrapulmonary respiratory tract infection, or the progression of abnormalities on chest radiograph after randomisation, or death due to pneumonia, or the inability to complete the study owing to adverse events Indeterminate - patient receives less than 80% of the study drug for reasons other than clinical failure, a concomitant infection outside the respiratory tract requiring antibiotic treatment, lost to follow-up, or death unrelated to the primary diagnosis. |
| 30-day mortality | End of the study, periodically by the DSMB | All cause |
| Time to clinical stability | End of the study | Patients are considered clinically stable if they fulfill all of these criteria: Temperature equal to or below 37.8 degrees celsius, heart rate equal to or below 100 beats per minute, respiratory rate equal to or below 24 breaths per minute, systolic blood pressure equal to or above 90 mmHg, arterial oxygen saturation equal to or above 90 percent or pO2 equal to or above 60 mmHg on room air, ability to maintain oral intake, normal mental status. |
| Relapse rate | End of the study | — |
Countries
Netherlands
Outcome results
None listed