Ten Versus 14 Days of Antibiotic Therapy in Culture-Proven Neonatal Sepsis: A Randomized, Controlled Trial

Reddy, A. Ravi Shankar; Sathenahalli, Veeraraja B.; Shivanna, Niranjan; Benakappa, Naveen; Bandiya, Prathik

doi:10.1007/s12098-021-03794-6

Cited by 6 publications

(9 citation statements)

References 8 publications

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“…The primary investigator was contacted to provide more details, but no response was received. Two studies 3,14 were judged to have a high risk of bias due to concerns in the following domains: deviation from intended interventions, measurement of the outcomes and selection of the reported results. One study 9 was considered to have concerns because of deviations from the intended intervention and selection of the reported results.…”

Section: Resultsmentioning

confidence: 99%

“…Two studies identified the short duration of antibiotics as receiving the appropriate antibiotics for seven days, 9,12 and the remaining studies for 10 days. 3,13,14 Most trials (4 of 5) identified the standard duration of antibiotics as receiving the appropriate antibiotics for 14 days. 3,12,13 Only two studies were conducted as non-inferiority and the rest were superiority trials.…”

Section: Re Sultsmentioning

confidence: 99%

“…Randomised controlled trials have conflicting evidence regarding the effectiveness of a shorter course compared to a longer one 3,9,12‐14 . Still, there is no clinical‐based evidence to inform the guideline development about the optimal duration of culture‐proven neonatal sepsis.…”

Section: Introductionmentioning

confidence: 99%

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Short course of intravenous antibiotics in the treatment of uncomplicated proven neonatal bacterial sepsis: A systematic review

Aljarbou,

Cuello,

Leslie

2023

Acta Paediatrica

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AimTo evaluate the efficacy and harms of a short (7–10 days) compared with a standard (10–14 days) duration of antibiotics in culture‐proven neonatal sepsis for reducing all‐cause mortality, treatment failure and duration of hospitalisation.MethodsMedline, EMBASE and Cochrane CENTRAL were searched for randomised trials.ResultsWe included five studies, all conducted in India (447 infants with a gestational age greater than 32 weeks). Except for one study, all studies were at high risk of bias. All‐cause mortality was reported in three studies with only one death reported in the standard duration regimen arm (243 patients, very low certainty). A meta‐analysis showed no evidence of the effect on treatment failure (RR of 1.47 [95% CI 0.48–4.50], 440 patients, five studies, very low certainty) of short‐term antibiotics. Short‐term antibiotic regimen shortened the duration of hospitalisation by 4 days (mean difference of −4.04 days [95% CI −5.47 to −2.61]; 4 studies; 371 patients; very low certainty).ConclusionAmong studies focused on infants born with a gestational age greater than 32 weeks, short‐term administration of antibiotics may shorten the duration of hospitalisation, but the evidence is very uncertain. The evidence on other predefined outcomes is very uncertain to draw definite conclusions.

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Section: Resultsmentioning

confidence: 99%

Section: Re Sultsmentioning

confidence: 99%

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Short course of intravenous antibiotics in the treatment of uncomplicated proven neonatal bacterial sepsis: A systematic review

Aljarbou,

Cuello,

Leslie

2023

Acta Paediatrica

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“…Reddy et al [7] in this issue of the Journal, published a randomized controlled trial among culture-proven sepsis comparing 10 d versus 14 d of antibiotic therapy. The primary outcome was the occurrence of sepsis with the same organism or clinical sepsis with negative culture during 28 d of life and similar to earlier studies [3][4][5].…”

mentioning

confidence: 99%

“…They could not blind the study because of the nature of the study. Moreover, when the neonate is asymptomatic, blood culture and screening tests are negative, it may not be justifiable to continue antibiotics beyond next 48 h [7].…”

mentioning

confidence: 99%

Fine-Tuning the Duration of Antibiotic Therapy for Neonatal Sepsis

Ballambattu

2022

Indian J Pediatr

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Ten- vs. 14-day antibiotic therapy for culture-positive neonatal sepsis

Islam,

Khatun,

Das

et al. 2023

Journal of Tropical Pediatrics

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Background Neonatal sepsis is a major determinant of neonatal mortality. There is a scarcity of evidence-based guidelines for the duration of antibiotics in culture-positive sepsis. Objectives The aim of this study was to compare the efficacy of 10- and 14-day antibiotic therapies in the management of culture-positive neonatal sepsis. Methods This randomized controlled trial was conducted in the neonatal intensive care unit of a tertiary care center among the neonates suffering from culture-positive sepsis (with signs of clinical remission on day 9 of antibiotic) between January 2023 and May 2023. Newborns with major congenital anomaly, deep-seated infections, multi-organ dysfunction, associated fungal infections/infection by multiple organisms and severe birth asphyxia were excluded. Two hundred and thirty-four newborns were randomized into two groups—study (received 10 days of antibiotics) and control (received 14 days of antibiotics). Treatment failure, hospital stay and adverse effects were compared between the two groups. p < 0.05 was taken as the limit of statistical significance. Results Median [interquartile range (IQR)] birth weight and gestational age of the study population (53.8% boys) were 2.424 kg (IQR: 2.183–2.695) and 37.3 weeks (IQR: 35.5–38.1), respectively. Acinetobacter was the most commonly isolated species (56, 23.9%). The baseline characteristics of both groups were almost similar. Treatment failure was similar in the study and control groups (3.8% vs. 1.7%, p = 0.40), with a shorter hospital stay [median (IQR): 14 (13–16) vs. 18 (17–19) days, p < 0.001]. Conclusion Ten-day antibiotic therapy was comparable with 14-day antibiotic therapy in efficacy, with a shorter duration of hospital stay and without any significant increase in adverse effects.

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Ten Versus 14 Days of Antibiotic Therapy in Culture-Proven Neonatal Sepsis: A Randomized, Controlled Trial

Cited by 6 publications

References 8 publications

Short course of intravenous antibiotics in the treatment of uncomplicated proven neonatal bacterial sepsis: A systematic review

Short course of intravenous antibiotics in the treatment of uncomplicated proven neonatal bacterial sepsis: A systematic review

Fine-Tuning the Duration of Antibiotic Therapy for Neonatal Sepsis

Ten- vs. 14-day antibiotic therapy for culture-positive neonatal sepsis

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