NCT03932123

Antibiotic Therapy for Early Onset Neonatal Sepsis

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Shandong University · Academic / Other
• Sex: All
• Age: 0 Days – 3 Days
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Early Onset Neonatal Sepsis

Interventions

Type	Name	Description
DRUG	Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime	Efficacy and safety of antibiotics

Timeline

• Start date: 2019-05-05
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2019-04-30
• Last updated: 2021-04-20

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study