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. 2021 May 8;5(5):CD013836.
doi: 10.1002/14651858.CD013836.pub2.

Antibiotic regimens for late-onset neonatal sepsis

Steven Kwasi Korang  1 , Sanam Safi  1 , Chiara Nava  2 , Gorm Greisen  3 , Munish Gupta  4 , Ulrik Lausten-Thomsen  5 , Janus C Jakobsen  6   7
Affiliations

Antibiotic regimens for late-onset neonatal sepsis

Steven Kwasi Korang et al. Cochrane Database Syst Rev. .

Abstract
in English, Spanish

Background: Neonatal sepsis is a major cause of morbidity and mortality. It is the third leading cause of neonatal mortality globally constituting 13% of overall neonatal mortality. Despite the high burden of neonatal sepsis, high-quality evidence in diagnosis and treatment is scarce. Due to the diagnostic challenges of sepsis and the relative immunosuppression of the newborn, many neonates receive antibiotics for suspected sepsis. Antibiotics have become the most used therapeutics in neonatal intensive care units, and observational studies in high-income countries suggest that 83% to 94% of newborns treated with antibiotics for suspected sepsis have negative blood cultures. The last Cochrane Review was updated in 2005. There is a need for an updated systematic review assessing the effects of different antibiotic regimens for late-onset neonatal sepsis.

Objectives: To assess the beneficial and harmful effects of different antibiotic regimens for late-onset neonatal sepsis.

Search methods: We searched the following electronic databases: CENTRAL (2021, Issue 3); Ovid MEDLINE; Embase Ovid; CINAHL; LILACS; Science Citation Index EXPANDED and Conference Proceedings Citation Index - Science on 12 March 2021. We also searched clinical trials databases and the reference lists of retrieved articles for randomised controlled trials (RCTs) and quasi-RCTs.

Selection criteria: We included RCTs comparing different antibiotic regimens for late-onset neonatal sepsis. We included participants older than 72 hours of life at randomisation, suspected or diagnosed with neonatal sepsis, meningitis, osteomyelitis, endocarditis, or necrotising enterocolitis. We excluded trials that assessed treatment of fungal infections.

Data collection and analysis: Three review authors independently assessed studies for inclusion, extracted data, and assessed risk of bias. We used the GRADE approach to assess the certainty of evidence. Our primary outcome was all-cause mortality, and our secondary outcomes were: serious adverse events, respiratory support, circulatory support, nephrotoxicity, neurological developmental impairment, necrotising enterocolitis, and ototoxicity. Our primary time point of interest was at maximum follow-up.

Main results: We included five RCTs (580 participants). All trials were at high risk of bias, and had very low-certainty evidence. The five included trials assessed five different comparisons of antibiotics. We did not conduct a meta-analysis due to lack of relevant data. Of the five included trials one trial compared cefazolin plus amikacin with vancomycin plus amikacin; one trial compared ticarcillin plus clavulanic acid with flucloxacillin plus gentamicin; one trial compared cloxacillin plus amikacin with cefotaxime plus gentamicin; one trial compared meropenem with standard care (ampicillin plus gentamicin or cefotaxime plus gentamicin); and one trial compared vancomycin plus gentamicin with vancomycin plus aztreonam. None of the five comparisons found any evidence of a difference when assessing all-cause mortality, serious adverse events, circulatory support, nephrotoxicity, neurological developmental impairment, or necrotising enterocolitis; however, none of the trials were near an information size that could contribute significantly to the evidence of the comparative benefits and risks of any particular antibiotic regimen. None of the trials assessed respiratory support or ototoxicity. The benefits and harms of different antibiotic regimens remain unclear due to the lack of well-powered trials and the high risk of systematic errors.

Authors' conclusions: Current evidence is insufficient to support any antibiotic regimen being superior to another. RCTs assessing different antibiotic regimens in late-onset neonatal sepsis with low risks of bias are warranted.

Antecedentes: La sepsis neonatal es una causa importante de morbilidad y mortalidad. Es la tercera causa de mortalidad neonatal a nivel mundial y constituye el 13% de la mortalidad neonatal total. A pesar de la elevada carga de la sepsis neonatal, la evidencia de alta calidad en el diagnóstico y el tratamiento es escasa. Debido a las dificultades de diagnóstico de la sepsis y a la relativa inmunosupresión del neonato, muchos reciben antibióticos por sospecha de sepsis. Los antibióticos se han convertido en el tratamiento más utilizado en las unidades de cuidados intensivos neonatales, y los estudios observacionales realizados en países de ingresos altos indican que entre el 83% y el 94% de los neonatos tratados con antibióticos por sospecha de sepsis tienen hemocultivos negativos. La última revisión Cochrane se actualizó en 2005. Se necesita una revisión sistemática actualizada que evalúe los efectos de los diferentes regímenes de antibióticos para la sepsis neonatal de inicio tardío.

Objetivos: Evaluar los efectos beneficiosos y perjudiciales de diferentes regímenes antibióticos para la sepsis neonatal de inicio tardío. MÉTODOS DE BÚSQUEDA: Se hicieron búsquedas en las siguientes bases de datos electrónicas: CENTRAL (2021, número 3); Ovid MEDLINE; Embase Ovid; CINAHL; LILACS; Science Citation Index EXPANDED y Conference Proceedings Citation Index ‐ Science el 12 de marzo de 2021. También se buscaron ensayos controlados aleatorizados (ECA) y cuasialeatorizados en las bases de datos de ensayos clínicos y en las listas de referencias de artículos identificados. CRITERIOS DE SELECCIÓN: Se incluyeron ECA que compararon diferentes regímenes de antibióticos para la sepsis neonatal de inicio tardío. Se incluyeron participantes mayores de 72 horas de vida en el momento de la asignación al azar, con sospecha o diagnóstico de sepsis neonatal, meningitis, osteomielitis, endocarditis o enterocolitis necrosante. Se excluyeron los ensayos que evaluaron el tratamiento de las infecciones micóticas. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión, de forma independiente, evaluaron los estudios para inclusión, extrajeron los datos y evaluaron el riesgo de sesgo. Se utilizó el método GRADE para evaluar la certeza de la evidencia. El desenlace principal fue la mortalidad por todas las causas, y los desenlaces secundarios fueron: eventos adversos graves, asistencia respiratoria, apoyo circulatorio, nefrotoxicidad, deterioro del desarrollo neurológico, enterocolitis necrosante y ototoxicidad. El punto temporal principal de interés fue el seguimiento máximo.

Resultados principales: Se incluyeron cinco ECA (580 participantes). Todos los ensayos tuvieron alto riesgo de sesgo y evidencia de certeza muy baja. Los cinco ensayos incluidos evaluaron cinco comparaciones diferentes de antibióticos. No se realizó un metanálisis debido a la falta de datos relevantes. De los cinco ensayos incluidos, un ensayo comparó cefazolina más amikacina con vancomicina más amikacina; un ensayo comparó ticarcilina más ácido clavulánico con flucloxacilina más gentamicina; un ensayo comparó cloxacilina más amikacina con cefotaxima más gentamicina; un ensayo comparó meropenem con atención estándar (ampicilina más gentamicina o cefotaxima más gentamicina); y un ensayo comparó vancomicina más gentamicina con vancomicina más aztreonam. Ninguna de las cinco comparaciones encontró evidencia de una diferencia al evaluar la mortalidad por todas las causas, los eventos adversos graves, el apoyo circulatorio, la nefrotoxicidad, el deterioro del desarrollo neurológico o la enterocolitis necrosante; sin embargo, ninguno de los ensayos se acercó a un tamaño de información que pudiera contribuir significativamente a la evidencia de los beneficios y los riesgos comparativos de cualquier régimen antibiótico en particular. Ninguno de los ensayos evaluó la asistencia respiratoria o la ototoxicidad. Los efectos beneficiosos y perjudiciales de los diferentes regímenes de antibióticos aún no están claros debido a la falta de ensayos con un poder estadístico adecuado y al alto riesgo de errores sistemáticos.

Conclusiones de los autores: La evidencia actual no es suficiente para apoyar que un régimen de antibióticos sea superior a otro. Se justifica la realización de ECA con bajo riesgo de sesgo que evalúen diferentes regímenes antibióticos en la sepsis neonatal de inicio tardío.

PubMed Disclaimer

Conflict of interest statement

The project received no funding.

SKK: none.

SS: none.

CN: none.

MG: none.

GG: none.

ULT: none.

JCJ: none.

Figures

1
1
Study flow diagram.
2
2
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.1
1.1. Analysis
Comparison 1: Cefazolin plus amikacin versus vancomycin plus amikacin, Outcome 1: All‐cause mortality
1.2
1.2. Analysis
Comparison 1: Cefazolin plus amikacin versus vancomycin plus amikacin, Outcome 2: Serious adverse events
2.1
2.1. Analysis
Comparison 2: Ticarcillin plus clavulanic acid versus flucloxacillin plus gentamicin, Outcome 1: All‐cause mortality
2.2
2.2. Analysis
Comparison 2: Ticarcillin plus clavulanic acid versus flucloxacillin plus gentamicin, Outcome 2: Serious adverse events
3.1
3.1. Analysis
Comparison 3: Cloxacillin plus amikacin versus cefotaxime plus gentamicin, Outcome 1: All‐cause mortality
3.2
3.2. Analysis
Comparison 3: Cloxacillin plus amikacin versus cefotaxime plus gentamicin, Outcome 2: Serious adverse events
3.3
3.3. Analysis
Comparison 3: Cloxacillin plus amikacin versus cefotaxime plus gentamicin, Outcome 3: Circulatory support
3.4
3.4. Analysis
Comparison 3: Cloxacillin plus amikacin versus cefotaxime plus gentamicin, Outcome 4: Nephrotoxicity
4.1
4.1. Analysis
Comparison 4: Meropenem versus standard care (ampicillin plus gentamicin or cefotaxime plus gentamicin), Outcome 1: All‐cause mortality
4.2
4.2. Analysis
Comparison 4: Meropenem versus standard care (ampicillin plus gentamicin or cefotaxime plus gentamicin), Outcome 2: Serious adverse events
4.3
4.3. Analysis
Comparison 4: Meropenem versus standard care (ampicillin plus gentamicin or cefotaxime plus gentamicin), Outcome 3: Neurological developmental impairment
4.4
4.4. Analysis
Comparison 4: Meropenem versus standard care (ampicillin plus gentamicin or cefotaxime plus gentamicin), Outcome 4: Necrotising enterocolitis
5.1
5.1. Analysis
Comparison 5: Vancomycin plus gentamicin versus vancomycin plus aztreonam, Outcome 1: All‐cause mortality
5.2
5.2. Analysis
Comparison 5: Vancomycin plus gentamicin versus vancomycin plus aztreonam, Outcome 2: Serious adverse events
5.3
5.3. Analysis
Comparison 5: Vancomycin plus gentamicin versus vancomycin plus aztreonam, Outcome 3: Necrotising enterocolitis
See this image and copyright information in PMC

Update of

  • doi: 10.1002/14651858.CD013836

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