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Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update

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Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update Antibiotic Use for Sepsis in Neonates and Children: 2016 Evidence Update Aline Fuchsa, Julia Bielickia,b, Shrey Mathurb, Mike Sharlandb, Johannes N. Van Den Ankera,c a Paediatric Pharmacology and Pharmacometrics, University Children's Hospital Basel, Basel, Switzerland b Paediatric Infectious Disease Research Group, Institute for Infection and Immunity, St George's University of London, London, United Kingdom c Division of Clinical Pharmacology, Children’s National Health System, Washington, DC, USA WHO-Reviews 1 TABLE OF CONTENTS 1. INTRODUCTION ............................................................................................................................... 3 1.1. Aims ......................................................................................................................................... 3 1.2. Background ............................................................................................................................. 3 1.2.1. Definition and diagnosis ................................................................................................. 3 Neonatal Sepsis ............................................................................................................................... 3 Paediatric Sepsis ............................................................................................................................. 4 Community versus hospital acquired sepsis .................................................................................. 5 1.2.2. Microbiology ................................................................................................................... 5 1.2.3. Burden of sepsis .............................................................................................................. 5 1.2.4. Current WHO guidelines ................................................................................................. 7 1.2.5. Trial design ...................................................................................................................... 8 2. METHODS ........................................................................................................................................ 9 3. RESULTS ......................................................................................................................................... 10 3.1. Synopsis of review results ........................................................................................................ 10 3.1.1. Evidence for currently recommended penicillin, gentamicin and ceftriaxone .................. 10 3.1.2. Data on antimicrobial resistance ......................................................................................... 13 3.1.3. Evidence for alternative regimen ......................................................................................... 13 3.1.4. Alternative and new drugs not included in clinical trials .................................................... 14 3.2. Synopsis of international guidelines ........................................................................................ 15 4. SAFETY DATA................................................................................................................................. 20 5. DOSING CONSIDERATIONS ........................................................................................................... 21 6. COST PER TREATMENT COURSE ................................................................................................... 24 7. OTHER INTERVENTIONS ................................................................................................................ 25 8. ONGOING CLINICAL TRIALS .......................................................................................................... 25 9. DISCUSSION & RESEARCH OUTLOOK ........................................................................................... 26 2 1. INTRODUCTION 1.1. Aims Sepsis remains a leading cause of mortality and morbidity, especially during the first five days of life and in low and middle-income countries (LMIC) [1]. Hospital infection also remains a major cause of mortality in children despite progress encountered in the last decades. WHO recommends ampicillin (or penicillin; cloxacillin if staphylococcal infection is suspected) plus gentamicin for empiric treatment of neonates with suspected clinical sepsis; when referral is not possible, once daily gentamicin plus oral amoxicillin may be used. It is known, however, that in many countries, agents with a broader spectrum, such as third-generation cephalosporins, are commonly used to treat neonatal and infant sepsis [2] Against this background, concerns are increasing regarding bacterial pathogens with reduced susceptibility to empiric medication with variations both between and within LMIC [3]. The WHO seeks to provide a paediatric perspective on antibiotics to be included on the list of essential medicines, which is currently in the process of being updated. The potential need to revise the existing WHO guidelines based on new antimicrobial resistance (AMR) data or evidence relating to drug safety in neonates and children must be evaluated. For this purpose, a number of reviews have been commissioned to address these aspects. This review collates evidence to support current empiric antibiotic recommendations for suspected or confirmed sepsis in neonates and children according to the most recent (≥ year 2012) relevant studies. 1.2. Background 1.2.1. Definition and diagnosis Neonatal Sepsis An accepted definition of sepsis in neonates is lacking. According to the report on the expert meeting on neonatal and paediatric sepsis of EMA (2010) [4], neonatal sepsis can be defined by the presence of at least two clinical symptoms and at least two laboratory signs in the presence of or as a result of suspected or proven infection (positive culture, microscopy or polymerase chain reaction) (Table 1): Clinical signs Laboratory signs • Modified body temperature: core temperature • White blood cells (WBC) count: <4,000 x109 greater than 38,5 °C or less than 36 °C AND/OR cells/L OR >20,000 x109 cells/L temperature instability • Immature to total neutrophil ratio (I/T) greater • Cardiovascular instability: bradycardia (mean HR than 0.2 less than the 10th percentile for age in the • Platelet count <100,000 x109 cells/L absence of external vagal stimulus, beta- • C reactive protein > 15 mg/L OR procalcitonin ≥ 2 blockers or congenital heart disease OR ng/ml (The cut-off for procalcitonin in neonatal otherwise unexplained persistent depression sepsis has not been clearly defined, as the over a 0.5 h time period) OR tachycardia (mean currently available published data are still HR greater than 2 SD above normal for age in the controversial). absence of external stimulus, chronic drugs and • Glucose intolerance confirmed at least 2 times: painful stimuli OR otherwise unexplained hyperglycaemia (blood glucose >180 mg/dL or 10 persistent elevation over a 0,5 h to 4 h time mMol/L) OR hypoglycaemia (glycaemia < 45 period) AND/OR rhythm instability reduced mg/dL or 2.5 mMol/L) when receiving age urinary output (less than 1 mL/kg/h), specific normal range glucose amounts hypotension (mean arterial pressure less than • Metabolic acidosis: Base excess (BE) <-10 mEq/L the 5th percentile for age), mottled skin, OR Serum lactate > 2 mMol/L impaired peripheral perfusion • Skin and subcutaneous lesions: petechial rash, sclerema 3 Clinical signs Laboratory signs • Respiratory instability: apnoea episodes OR tachypnea episodes (mean respiratory rate (RR) over 2 SD above normal for age) OR increased oxygen requirements OR requirement for ventilation support • Gastrointestinal: feeding intolerance, poor sucking, abdominal distention • Non-specific: irritability, lethargy and hypotonia Table 1. Clinical signs and laboratory signs (presence of at least two clinical symptoms and at least two laboratory signs) associated with neonatal sepsis according to the report on the expert meeting on neonatal and paediatric sepsis of EMA (2010) In resource-limited settings with limited and/or intermittent access to laboratory evaluations this definition is not workable. Consequently, a highly specific definition of neonatal sepsis is not available for LMIC settings. Instead it is recommended that initiation of antibiotics should be prompted by clinical signs of Possible Serious Bacterial Infection (PSBI), a highly sensitive definition aiming to reduce the number of false negatives (i.e. missed cases of sepsis). Clinical signs of PSBI, according to the Young Infants Clinical Signs Clinical Study criteria of WHO’s Integrated Management of Childhood Illness (IMCI) guidelines, are defined as the presence of any one of a history of difficulty feeding, history of convulsions, movement only when stimulated, respiratory rate of 60 or more breaths per min, severe chest retractions, or a temperature of 37.5 °C or higher or 35.5 °C or lower [5]. Paediatric Sepsis The expert meeting on neonatal and paediatric sepsis of EMA (2010) [4] endorsed the International Paediatric Sepsis Consensus Conference of sepsis definition for paediatric patients, that is: • Infection: A suspected or proven (by positive culture, tissue stain or PCR test) infection caused by any pathogen OR a clinical syndrome associated with a high probability of infection. Evidence of infection includes positive findings on clinical exam, imaging or laboratory tests (e.g. WBC in a normally sterile blood fluid, perforated
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