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Pharmacokinetics of meropenem and amoxicillin in neonates with septicemia

Pharmacokinetics of meropenem and amoxicillin in neonates with septicemia

Status
Recruiting
Phases
Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100053876
Enrollment
Unknown
Registered
2021-12-02
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-31

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

Conditions

sepsis

Interventions

Group 1:Meropenem
Group 2:Amoxicillin
Healthy group:None

Sponsors

Peking University Third Hospital Drug Clinical Trial Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Neonates aged <=28 days after birth (including premature and full-term neonates), no gender limit; 2. The legal representative of the research subject can maintain good communication with the researcher and voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those born with congenital genetic metabolic diseases; 2. Congenital abnormalities of the kidneys and urethra, including renal hypoplasia/dysplasia, posterior urethral valves and other congenital abnormalities of the kidneys and urethra; 3. Patients with cystic kidney disease; 4. Patients with congenital nephrotic syndrome; 5. Bilateral renal vein thrombosis or renal artery thrombosis and renal infarction caused by improper placement of umbilical artery catheter; 6. Patients with urethral stricture and indwelling catheterization dysfunction caused by traumatic bladder catheterization; 7. There are major diseases such as serious hematological diseases, tumors, and immune diseases; 8. Those suffering from pyridoxine-dependent epilepsy and taking vitamin B6; 9. Those who have any other factors considered inappropriate by the pediatrician to participate in this trial.

Design outcomes

Primary

MeasureTime frame
maximum concentration (Cmax);time to achieve maximum concentration (Tmax);elimination rate (CL);

Countries

China

Contacts

Public ContactLiu Dongyang

Peking University Third Hospital Drug Clinical Trial Center

liudongyang@vip.sina.com+86 10 82265509

Outcome results

None listed

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