Amoxicillin vs. placebo to reduce symptoms in children with group A streptococcal pharyngitis : a randomized, multicenter, double-blind, non-inferiority trial

Article Article scientifique Article Amoxicillin vs. placebo to reduce symptoms in children with group A streptococcal pharyngitis : a randomized, multicenter, double-blind, non-inferiority trial eng 2024-08-31 2024-11 author Gualtieri Renato 0000-0001-8164-7284 Division of General Pediatrics, Department of Pediatrics, Gynaecology and Obstetrics, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. 974851 author Verolet Charlotte 0000-0003-3419-1434 Division of General Pediatrics, Department of Pediatrics, Gynaecology and Obstetrics, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. 646895 author Mardegan Chiara 0009-0000-1999-6045 Division of General Pediatrics, Department of Pediatrics, Gynaecology and Obstetrics, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. 845410 author Papis Sébastien 0000-0001-8100-5230 Division of General Pediatrics, Department of Pediatrics, Gynaecology and Obstetrics, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. 719312 author Loevy Natasha Division of General Pediatrics, Department of Pediatrics, Gynaecology and Obstetrics, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. 783066 author Asner Sandra Andréa Pediatric Infectious Diseases and Vaccinology Unit, Lausanne University Hospital, Lausanne, Switzerland. 105568 author Rohr Marie Madeleine 0000-0002-3343-7028 Division of General Pediatrics, Department of Pediatrics, Gynaecology and Obstetrics, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland.,Pediatric Infectious Diseases Unit, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. 861949 author Llor Juan Department of Pediatrics, Sion Hospital, Centre Hospitalier du Valais Romand, Sion, Switzerland. 757490 author Heininger Ulrich Department of Pediatric Infectious Diseases and Vaccinology, University Children's Hospital Basel, Basel, Switzerland. 770146 author Lacroix Laurence Elisabeth 0000-0001-8901-6778 Department of Pediatric Emergency Medicine, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. 84201 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) author Pittet Laure 0000-0002-2395-4574 Division of General Pediatrics, Department of Pediatrics, Gynaecology and Obstetrics, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. 633427 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) author Posfay Barbe Klara 0000-0001-9464-5704 Division of General Pediatrics, Department of Pediatrics, Gynaecology and Obstetrics, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. Klara.PosfayBarbe@hug.ch.,Pediatric Infectious Diseases Unit, Geneva University Children's Hospital and University of Geneva, Geneva, Switzerland. Klara.PosfayBarbe@hug.ch. 39230 Département de Pédiatrie, Gynécologie et Obstétrique (PETRI) 4773-4782 10.1007/s00431-024-05705-1 39215861 0340-6199 PMC11473506 https://link.springer.com/article/10.1007/s00431-024-05705-1 Unlabelled: The efficacy of antibiotic therapy for group A streptococcus (GAS) pharyngitis is debated. The role of antibiotics in preventing complications seems limited, with the main potential benefit being symptom duration reduction. Our study aimed to evaluate whether a placebo is non-inferior to amoxicillin in reducing fever duration. We randomized 88 children between 3 and 15 years of age presenting with acute symptoms of pharyngitis and a positive rapid antigen detection test for GAS to receive 6-day treatment with either placebo (n = 46) or amoxicillin (n = 42). The primary outcome was the difference in fever duration, with a non-inferiority threshold set at 12 h. The secondary outcomes included pain intensity and complications of streptococcal pharyngitis. The mean difference in fever duration between the amoxicillin and placebo groups was 2.0 h (95% CI, - 8.3 to 12.3) in the per-protocol analysis and 2.8 h (95% CI, - 6.5 to 12.2) in the intention-to-treat analysis. Treatment failure was observed in six participants in the placebo group and two in the amoxicillin group (relative risk, 2.15; 95% CI, 0.44-10.57). All patients were identified early and recovered well. There was no clinically relevant difference in pain intensity between groups over the 7 days following randomization, with the largest difference of 0.5 (95% CI, - 0.62-1.80) observed on day 3. Conclusion: Placebo appears to be non-inferior to amoxicillin in reducing fever duration. Pain intensity and risk of complications were similar between the two groups. These findings support the restrictive antibiotic treatment for streptococcal pharyngitis. What is known: • Group A streptococcus pharyngitis is a common reason for prescribing antibiotics in pediatric care. • In high-income countries, while antibiotic treatment has not been effective in preventing non-suppurative complications, the primary justification for their use remains the reduction of symptoms. What is new: • Our results suggest that antibiotics have a limited impact on the duration of fever and the intensity of pain in children with streptococcal pharyngitis. • Considering that suppurative complications can be promptly treated if they arise, we recommend a more judicious approach to antibiotic prescriptions. Trial registration: The trial is registered at the US National Institutes of Health (ClinicalTrials.gov) # NCT03264911 on 15.08.2017. Amoxicillin Group A Streptococcus Placebo Streptococcal pharyngitis Humans Pharyngitis / drug therapy Pharyngitis / microbiology Amoxicillin / therapeutic use Streptococcal Infections / drug therapy Streptococcal Infections / diagnosis Female Child Double-Blind Method Male Anti-Bacterial Agents / therapeutic use Child, Preschool Adolescent Streptococcus pyogenes Treatment Outcome Dewey 618 Hôpitaux Universitaires de Genève PRD 1-2015-I Société Académique de Genève #2015/36 Gertrude von Meissner-Stiftung 58 Département de pédiatrie, gynécologie et obstétrique 223 false 143 Centre de vaccinologie et d'immunologie néonatale 177 515 Recherche en infectiologie pédiatrique et en pédiatrie générale 853 1337 Laboratoire d'immunologie vaccinale humaine 1025 European journal of pediatrics 183 11 e0c2c4a2-5a32-4f92-b4cc-9744b9860a8f Article (Published version) Public Article_scientifique_from_europePmc.pdf 1750818 application/pdf CC BY-4.0 69c425c59cbcc8284a206ad4156455c395a9e66df8fb9edcd959a5c30de7d2b3 03126ac9-eab3-4546-8f3a-48d21f387e89 Appendix Public 431_2024_5705_MOESM1_ESM.docx 20136 application/vnd.openxmlformats-officedocument.wordprocessingml.document ce16ccfc0097bd58a80a415911f0760d81426c5cfe65c75d6e2c7f30f7210737 openAccess Faculté de médecine / Section de médecine clinique / Département de pédiatrie, gynécologie et obstétrique

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Amoxicillin vs. placebo to reduce symptoms in children with group A streptococcal pharyngitis : a randomized, multicenter, double-blind, non-inferiority trial	European journal of pediatrics			2024	63	1,611

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Llor, Juan