Antibiotic Therapy for Early Onset Neonatal Sepsis
NCT03932123 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500
Last updated 2021-04-20
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
- DRUG
-
Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin,cefotaxime
Efficacy and safety of antibiotics
Sponsors & Collaborators
-
Tianjin Central Hospital of Gynecology Obstetrics
collaborator OTHER -
Shandong Provincial Hospital
collaborator OTHER_GOV -
Qianfoshan Hospital
collaborator OTHER -
Shandong University
lead OTHER
Eligibility
- Min Age
- 0 Days
- Max Age
- 3 Days
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-05-05
- Primary Completion
- 2025-10-31
- Completion
- 2025-12-31
- FDA Drug
- Yes
Countries
- China
Study Locations
More Related Trials
-
A Randomized Controlled Trial Investigating if Antibiotic Use in the First 48 Hours of Life Adversely Impacts the Preterm Infant Microbiome
NCT02477423 ·Status: COMPLETED ·Phase: NA
-
Efficacy And Safety Of Short Course Antibiotic Therapy In Preterm Neonates With Early Onset Sepsis
NCT06197269 ·Status: COMPLETED ·Phase: NA
-
Pharmacokinetics and Safety of Piperacillin-tazobactam in Neonates
NCT00873327 ·Status: COMPLETED ·Phase: PHASE1
-
Early Antibiotic Therapy and Vaccination
NCT04109833 ·Status: UNKNOWN
-
Promoting Optimal Treatment Choices in Neonates With Suspected Early-Onset Sepsis
NCT06845332 ·Status: RECRUITING
-
Validation of Biomarkers Performance to Reduce Antibiotics overUse in newBorns With Suspected Clinical Signs of InfectionS
NCT06058819 ·Status: RECRUITING
-
Efficacy, Pharmacokinetics and Safety of Meropenem in Infants Below 90 Days With Clinical or Confirmed Late-onset Sepsis
NCT01551394 ·Status: COMPLETED ·Phase: PHASE3
-
Role of Antibiotics in Preventing Infection in Babies Born Through Meconium Stained Liquor
NCT01290003 ·Status: COMPLETED ·Phase: NA
-
Intravenous and Oral Fosfomycin in Hospitalised Neonates With Clinical Sepsis
NCT03453177 ·Status: COMPLETED ·Phase: PHASE2
-
Ceftriaxone and Jaundice in Neonates
NCT03133637 ·Status: COMPLETED
-
Oral Amoxicillin and Cephalexin PK/PD in Neonates
NCT04916951 ·Status: COMPLETED ·Phase: PHASE1
-
Population Pharmacokinetic of Piperacillin/Tazobactam in Maternal and Neonatal Populations
NCT06076200 ·Status: RECRUITING
-
A Pilot Randomized Controlled Trial for Antibiotic Exposure in Neonatal Sepsis Using Neutrophil CD64
NCT01825421 ·Status: WITHDRAWN ·Phase: NA
-
NICU Antibiotics and Outcomes Trial
NCT03997266 ·Status: COMPLETED ·Phase: PHASE4
-
Intrapartum Vancomycin for Group B Streptococcus (GBS) Prophylaxis
NCT02143154 ·Status: COMPLETED
-
Neonatal Suspected Sepsis Treated With Cefazolin or Vancomycin
NCT01867138 ·Status: COMPLETED ·Phase: PHASE3
-
An Open Label Study to Describe the Pharmacokinetics of Cefazolin in Preterm Neonates
NCT00850122 ·Status: COMPLETED ·Phase: PHASE1
-
Comparison of Two Antibiotic Prophylactic Protocols in Preterm Premature Rupture of the Membranes
NCT02819570 ·Status: UNKNOWN ·Phase: PHASE4
-
Efficacy and Safety of Colistin Based Antibiotic Therapy
NCT04764058 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
Risk Factors for Colonization or Infection With Carbapenem-Resistant Enterobacteriaceae in Children
NCT04535661 ·Status: RECRUITING
-
Resistant Bacteria in Children in France
NCT06036628 ·Status: COMPLETED
-
AMR of Streptococcus Pneumoniae Carriage Strains
NCT00198640 ·Status: COMPLETED ·Phase: NA
-
Neonatal Bacterial Colonization Study
NCT03896893 ·Status: UNKNOWN ·Phase: NA
-
Reduction of Intravenous Antibiotics In Neonates
NCT03247920 ·Status: COMPLETED ·Phase: PHASE4
-
An Open Label Study to Describe the Pharmacokinetics of Daptomycin in Infants
NCT00942149 ·Status: COMPLETED ·Phase: PHASE1