Procalcitonin and lung ultrasound algorithm to diagnose severe pneumonia in critical paediatric patients (PROLUSP study)
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(2020) 21:255
STUDY PROTOCOL
Open Access
Procalcitonin and lung ultrasound algorithm to diagnose severe pneumonia in critical paediatric patients (PROLUSP study). A randomised clinical trial Javier Rodríguez-Fanjul1, Carmina Guitart2,3, Sara Bobillo-Perez2,3, Mònica Balaguer2*
and Iolanda Jordan2,3,4
Abstract Background: Lung ultrasound (LUS) in combination with a biomarker has not yet been studied. We propose a clinical trial where the primary aims are: 1. To assess whether an algorithm with LUS and procalcitonin (PCT) may be useful for diagnosing bacterial pneumonia; 2. To analyse the sensitivity and specificity of LUS vs chest X-ray (CXR). Methods/design: A 3-year clinical trial. Inclusion criteria: children younger than 18 years old with suspected pneumonia in a Paediatric Intensive Care Unit. Patients will be randomised into two groups: Experimental Group: LUS will be performed as first lung image. Control Group: CXR will be performed as first pulmonary image. Patients will be classified according to the image and the PCT: a) PCT < 1 ng/mL and LUS/CXR are not suggestive of bacterial pneumonia (BN), no antibiotic will be prescribed; b) LUS/CXR are suggestive of BN, regardless of the PCT, antibiotic therapy is recommended; c) LUS/CXR is not suggestive of BN and PCT > 1 ng/mL, antibiotic therapy is recommended. Conclusion: This algorithm will help us to diagnose bacterial pneumonia and to prescribe the correct antibiotic treatment. A reduction of antibiotics per patient, of the treatment length, and of the exposure to ionizing radiation and in costs is expected. Trial registration: NCT04217980.
Background Pneumonia is responsible for more than 2 million child deaths around the world; it is the leading cause of childhood morbidity and mortality [1]. Moreover, severe lower respiratory infection is the most common cause of admission to paediatric intensive care units (PICUs) [2]. Around 60–70% of these have a viral etiology [3]. For physicians, it is important to differentiate between viral and bacterial infection because each entails a different * Correspondence: [email protected] 2 Paediatric Intensive Care Unit, Hospital Sant Joan de Déu, University of Barcelona, P° Sant Joan de Déu, 2, 08950 Esplugues, Barcelona, Spain Full list of author information is available at the end of the article
therapeutic approach (whether antibiotics are indicated and the treatment duration), a different prognosis in the short and long term, and requires a different hospital isolation policy [4, 5]. It is challenging to rule whether a case of pneumonia is viral or bacterial in origin [6–8]. Clinical symptoms are similar and although conventional chest radiographs (CXR) have traditionally been considered the best diagnostic option [9], the specificity of CXR for determining bacterial etology remains low. Chest computed tomography may detect smaller pulmonary consolidations not visible via CXR, but it cannot be routinely performed on critically ill patients due to cost, exposure to radiation, and transportation
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