Early Onset Neonatal Sepsis
Conditions
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.
Interventions
DRUGPiperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime
Efficacy and safety of antibiotics
Sponsors
Tianjin Central Hospital of Gynecology Obstetrics
Shandong Provincial Hospital
Qianfoshan Hospital
Shandong University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
0 Days to 3 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospitalization | In the first month of patients' life | Duration of hospitalization of patients |
| PD target | Through study completion, an average of 3 days | The time of free drug concentration exceeding the minimal inhibitory concentration (fT\>MIC) |
| White blood cell count | Through study completion, an average of 3 days | White blood cell count in ×10\^9/L |
| Treatment duration | Through study completion, an average of 3 days | Duration of initial antibiotic therapy |
| C-reactive protein | Through study completion, an average of 3 days | C-reactive protein in mg/L |
| 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 |
| Procalcitonin | Through study completion, an average of 3 days | Procalcitonin in ng/mL |
Countries
China
Contacts
Primary ContactWei Zhao, Ph.D
Outcome results
None listed