Antibiotic Therapy for Early Onset Neonatal Sepsis

Shandong University

Status: Enrolling

Conditions: Early Onset Neonatal Sepsis

Treatments: Drug: Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime

Study type: Observational

Funder types: Other

Identifiers

NCT03932123

2019_EOS_001

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: Under 3 days old

Volunteers: No Healthy Volunteers

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.