Antibiotic Therapy for Early Onset Neonatal Sepsis

Early Onset Neonatal Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03932123
• Other study ID #: 2019_EOS_001
• Status: Recruiting
• Start date: May 5, 2019
• Est. completion date: December 2025

Study information

• Verified date: April 2021
• Source: Shandong University
• Contact: Wei Zhao, Ph.D
• Phone: 86053188383308
• Email: zhao4wei2[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

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.

Related Conditions & MeSH terms

• Early Onset Neonatal Sepsis
• Neonatal Sepsis
• Sepsis
• Toxemia

Intervention

Drug:
• Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin,cefotaxime
Efficacy and safety of antibiotics

Locations

Country	Name	City	State
China	Tianjin Central Hospital of Gynecology Obstetrics	Tianjin	Tianjin

Sponsors (4)

Lead Sponsor	Collaborator
Shandong University	Qianfoshan Hospital, Shandong Provincial Hospital, Tianjin Central Hospital of Gynecology Obstetrics

Country where clinical trial is conducted

China, 

Outcome

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