OBJECTIVE: To compare a short course of antibiotics (48 to 96 hours) and a standard course of antibiotics (7 days) for probable neonatal sepsis. DESIGN: Randomized, controlled, open-labeled trial with blocking and stratification according to birth weight. SETTING:Tertiary care, referral, teaching hospital in Northern India. PARTICIPANTS: Neonates >30 wks gestation and >1000 g at birth, with probable sepsis (clinical signs of sepsis, raised C reactive protein) were enrolled. Babies with major malformations, severe birth asphyxia, meningitis, bone or joint or deep-seated infection, those who were already on antibiotics, and those undergoing surgery were excluded. Neonates, who had clinically remitted on antibiotic therapy by the time a sterile blood culture report was received were randomized. INTERVENTION: In the intervention arm, antibiotics were stopped after the 48 hour culture was reported sterile. In the control arm, antibiotics were continued to a total of 7 days. MAIN OUTCOME MEASURE: Treatment failure defined as reappearance of signs suggestive of sepsis within 15 days of stopping antibiotics, supported by laboratory evidence and adjudicated by a blinded expert committee. RESULTS:52 neonates were randomized to receive a short course or 7 day course (n=26 each). Baseline variables were balanced in the 2 groups. There was no significant difference in the treatment failures between the 2 groups (3 babies in the 7-day group vs none in short course group, P=0.23). CONCLUSION: No difference in the treatment failure rates could be identified between short course and 7-day groups among neonates >30 weeks and > 1000 grams with probable sepsis.
RCT Entities:
OBJECTIVE: To compare a short course of antibiotics (48 to 96 hours) and a standard course of antibiotics (7 days) for probable neonatal sepsis. DESIGN: Randomized, controlled, open-labeled trial with blocking and stratification according to birth weight. SETTING: Tertiary care, referral, teaching hospital in Northern India. PARTICIPANTS: Neonates >30 wks gestation and >1000 g at birth, with probable sepsis (clinical signs of sepsis, raised C reactive protein) were enrolled. Babies with major malformations, severe birth asphyxia, meningitis, bone or joint or deep-seated infection, those who were already on antibiotics, and those undergoing surgery were excluded. Neonates, who had clinically remitted on antibiotic therapy by the time a sterile blood culture report was received were randomized. INTERVENTION: In the intervention arm, antibiotics were stopped after the 48 hour culture was reported sterile. In the control arm, antibiotics were continued to a total of 7 days. MAIN OUTCOME MEASURE: Treatment failure defined as reappearance of signs suggestive of sepsis within 15 days of stopping antibiotics, supported by laboratory evidence and adjudicated by a blinded expert committee. RESULTS: 52 neonates were randomized to receive a short course or 7 day course (n=26 each). Baseline variables were balanced in the 2 groups. There was no significant difference in the treatment failures between the 2 groups (3 babies in the 7-day group vs none in short course group, P=0.23). CONCLUSION: No difference in the treatment failure rates could be identified between short course and 7-day groups among neonates >30 weeks and > 1000 grams with probable sepsis.
Authors: Tamar F Barlam; Sara E Cosgrove; Lilian M Abbo; Conan MacDougall; Audrey N Schuetz; Edward J Septimus; Arjun Srinivasan; Timothy H Dellit; Yngve T Falck-Ytter; Neil O Fishman; Cindy W Hamilton; Timothy C Jenkins; Pamela A Lipsett; Preeti N Malani; Larissa S May; Gregory J Moran; Melinda M Neuhauser; Jason G Newland; Christopher A Ohl; Matthew H Samore; Susan K Seo; Kavita K Trivedi Journal: Clin Infect Dis Date: 2016-04-13 Impact factor: 9.079
Authors: Rían Hayes; Jack Hartnett; Gergana Semova; Cian Murray; Katherine Murphy; Leah Carroll; Helena Plapp; Louise Hession; Jonathan O'Toole; Danielle McCollum; Edna Roche; Elinor Jenkins; David Mockler; Tim Hurley; Matthew McGovern; John Allen; Judith Meehan; Frans B Plötz; Tobias Strunk; Willem P de Boode; Richard Polin; James L Wynn; Marina Degtyareva; Helmut Küster; Jan Janota; Eric Giannoni; Luregn J Schlapbach; Fleur M Keij; Irwin K M Reiss; Joseph Bliss; Joyce M Koenig; Mark A Turner; Christopher Gale; Eleanor J Molloy Journal: Pediatr Res Date: 2021-11-06 Impact factor: 3.756