Antibiotic Therapy for Early Onset Neonatal Sepsis

Study Overview
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Brief Summary
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Antibiotic therapy for early onset neonatal sepsis recommended by international guidelines and relevant studies is only kind of treatment regimen that penicillin G/ penicillin/ampicillin combined with gentamicin as the first-line treatment regimen. However, it is not applicable to the clinical practice in many countries and regions. We aim to study efficacy and safety of antibiotics in the treatment of early onset neonatal sepsis.

Official Title
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Efficacy and Safety of Antibiotics in the Treatment of Early Onset Neonatal Sepsis

Conditions
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Early Onset Neonatal Sepsis

Intervention / Treatment
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* Drug: Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age: postnatal age ≤ 72h; Meets NICE guidelines for using antibiotics to treat EONS; Azlocillin used as part of antimicrobial treatment; Parental written consent. Exclusion Criteria: Expected survival time less than the treatment cycle; Major congenital malformations; Undergoing surgery within the first week of life; Receiving other systemic trial drug therapy; Other factors that the researcher considers unsuitable for inclusion.

Ages Eligible for Study
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Minimum Age: 0 Days
Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime|Efficacy and safety of antibiotics|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failure | requiring additional courses of antibiotic therapy within 72 hours after ending initial antibiotic therapy and/or progression of the illness, necessitating a change of antibiotic and/or blood culture isolate reported resistant to the antibiotic. | 72 hours after ending initial antibiotic therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration | Duration of initial antibiotic therapy | Through study completion, an average of 3 days | 
| Duration of hospitalization | Duration of hospitalization of patients | In the first month of patients' life | 
| PD target | The time of free drug concentration exceeding the minimal inhibitory concentration (fT>MIC) | Through study completion, an average of 3 days | 
| White blood cell count | White blood cell count in ×10^9/L | Through study completion, an average of 3 days | 
| Procalcitonin | Procalcitonin in ng/mL | Through study completion, an average of 3 days | 
| C-reactive protein | C-reactive protein in mg/L | Through study completion, an average of 3 days | 
| Death | Death in the first month of life | In the first month of patients' life | 
| Adverse events | Drug-related adverse events and serious adverse events | Through study completion, an average of 3 days |