early-onset neonatal sepsis
Conditions
Interventions
conventional treatment group and model treatment group:The Chinese neonates with EONS will undergo latamoxef regimens described as follows: 30mg/kg q12h in the conventional treatment group, 20mg/kg,
conventional treatment group and model treatment group:The opportunistic blood sampling method will be used to collect samples for testing the determination the drug concentration in blood.
Sponsors
Beijing Children's Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. postnatal age in days (PNA) =18h. Sepsis can be ruled out if there are no abnormal clinical manifestations, negative blood culture, and less than 2 consecutive non-specific blood tests (white blood cell count, immature neutrophil count, platelet count, CRP, PCT, etc.) at 24h intervals; (2) The patient was clinically diagnosed with clinical abnormalities and met any of the following conditions at the same time: the blood non-specific tests were >=2 positive, the cerebrospinal fluid test was suppurative meningitis change, the pathogenic DNA was detected in the blood; The abnormal clinical manifestations are as follows: 1) The whole body: fever, hypothermia, poor response, poor feeding, edema, low Apgar score; 2) Digestive system: jaundice, abdominal distension, vomiting or gastric retention, diarrhea and hepatosplenomegaly. 3) Respiratory system: dyspnea, apnea, cyanosis, etc.; 4) Circulatory system: pale face, cold limbs, bradycardia, tachycardia, marbled skin, hypotension or capillary filling time >3 s; 5) Urinary system: oliguria and renal failure; 6) Blood system: bleeding, purpura; 3. When the patient was having clinical manifestations and blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture was positive, the diagnosis was confirmed; 4. Latamoxef was used for treatment; 5. Written informed consent was signed by the parents or legal guardian of the neonate.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following exclusion criteria shall not be admitted to this study: (1) The expected survival time may be smaller than the treatment cycle; (2) Severe congenital malformations; (3) Undergo surgery within the first week of birth; (4) Receive other drug treatment trial; (5) There are other factors that researchers believe are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 70% fT>MIC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Latamoxef treatment failure;Treatment cycle of latamoxef;Changes of white blood cell count (WBC), C-reactive protein (CRP) and procalcitonin (PCT);Blood culture results during administration;Incidence of adverse reactions; | — |
Countries
China
Contacts
Public ContactHui Qi
Beijing Children's Hospital, Capital Medical University
Outcome results
None listed