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Ceftriaxone for late onset neonatal sepsis in China: a randomized controlled study

Ceftriaxone for late onset neonatal sepsis in China: a randomized controlled study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042338
Enrollment
Unknown
Registered
2021-01-19
Start date
2021-01-22
Completion date
Unknown
Last updated
2021-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Late onset neonatal sepsis

Interventions

conventional treatment group:Ceftriaxone 80mg/kg, qd
model treatment group:Ceftriaxone 40mg/kg, q12h

Sponsors

Beijing Children's Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Postnatal age in days (PNA) > 3. 2. It met the diagnostic criteria of LONS (according to the Expert Consensus on the Diagnosis and Treatment of Neonatal Sepsis (2019), Chinese Journal of Pediatrics, Vol. 57, No. 4, April 2019). (1) clinically diagnosed with clinical abnormalities, and meeting any of the following conditions: 1) >= 2 positive non-specific blood tests; 2) changes in cerebrospinal fluid as suppurative meningitis, and 3) DNA of pathogenic bacteria detected in blood. (2) The diagnosis was confirmed as clinical presentation, positive in blood culture or cerebrospinal fluid (or other sterile cavity fluid) culture. 3. Treatment with ceftriaxone sodium. 4. 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 shorter than the treatment cycle. 2. Severe congenital malformation. 3. Undergo surgery within the first week of birth. 4. Receiving other systemic experimental drug therapy. 5. There are other factors that researchers believe are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
70% fT>MIC;

Secondary

MeasureTime frame
Ceftriaxone treatment failure;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

qh20021983@163.com+86 10-59616980

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026