Antibiotic Therapy for Early Onset Neonatal Sepsis

Recruiting

• Conditions: Early Onset Neonatal Sepsis

• Registration Number: NCT03932123
• Lead Sponsor: Shandong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-29
• Study First Posted: 2019-04-30
• Study Start: 2019-05-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-18
• Last Update Posted: 2021-04-20
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment failure	72 hours after ending initial antibiotic therapy	* 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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Tianjin Central Hospital of Gynecology Obstetrics; 🇨🇳 Tianjin, Tianjin, China