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| Name | Class |
|---|---|
| Foreest Medical School | UNKNOWN |
| Pulmoscience | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Common clinical practice | Active Comparator | Treatment according to current guidelines. Often a 7 day course of antibiotics. Initial treatment should be broad spectrum antibiotics and can be narrowed down if a specific pathogen is identified. |
|
| CRP-guided treatment | Experimental | Treatment according to CRP levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed. |
|
| PCT guided treatment | Experimental | Treatment according to PCT levels. Patients will be started on broad spectrum antibiotics for at least 3 days, treatment can be switched to small-spectrum antibiotics if a specific pathogen is identified. From day 4 to 7 daily blood tests will be performed in order to evaluate whether or not treatment can be discontinued. If treatment is discontinued, no more blood tests will be performed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discontinuation of treatment according to CRP levels | Drug | The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Length of antibiotic treatment | End of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Length of stay | End of the study | |
| Clinical response | 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. |
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Inclusion Criteria:
Male and female patients with a diagnosis of CAP and all criteria listed below:
Age 18 or above, no upper age limit will be employed.
Patients must require hospitalisation.
Clinical presentation of an acute illness with one or more of the following symptoms:
New consolidation(s) on the chest radiograph.
Written informed consent obtained.
(Pre-event) Life expectancy > 30 days
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Ruud Duijkers, MSc, MD | Medisch Centrum Alkmaar | Study Director |
| Wim G Boersma, MD, PhD, MSc | Medisch Centrum Alkmaar | Principal Investigator |
| Dominic Snijders, MSc, PhD, MD | Slotervaart ziekenhuis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Centre Alkmaar | Alkmaar | North Holland | 1815JD | Netherlands | ||
| Slotervaart Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40523722 | Derived | Hessels L, Duijkers R, Schoorl M, Terpstra L, Thijs W, Boersma W. The Value of Soluble Urokinase Plasminogen Activator Receptor (suPAR) as Predictive Tool in Hospitalised Patients With Community-Acquired Pneumonia (CAP). Clin Respir J. 2025 Jun;19(6):e70089. doi: 10.1111/crj.70089. | |
| 39163362 | Derived | Duijkers R, Prins HJ, Kross M, Snijders D, van den Berg JWK, Werkman GM, van der Veen N, Schoorl M, Bonten MJM, van Werkhoven CH, Boersma WG. Biomarker guided antibiotic stewardship in community acquired pneumonia: A randomized controlled trial. PLoS One. 2024 Aug 20;19(8):e0307193. doi: 10.1371/journal.pone.0307193. eCollection 2024. |
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|
| Discontinuation of treatment according to PCT levels | Drug | The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value. |
|
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| Treatment according to current guidelines | Drug | Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary. |
|
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| End of the study |
| 30-day mortality | All cause | End of the study, periodically by the DSMB |
| Time to clinical stability | 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. | End of the study |
| Relapse rate | End of the study |
| Amsterdam |
| North Holland |
| 1006BK |
| Netherlands |
| ISALA clinics | Zwolle | Overijssel | 8025 AB | Netherlands |
| ID | Term |
|---|---|
| D000098968 | Community-Acquired Pneumonia |
| ID | Term |
|---|---|
| D017714 | Community-Acquired Infections |
| D007239 | Infections |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D012140 | Respiratory Tract Diseases |
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