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Pharmacokinetics of Imipenem and Cilastatin Sodium in patients with different degrees of burns

Pharmacokinetics of Imipenem and Cilastatin Sodium in patients with different degrees of burns

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000034851
Enrollment
Unknown
Registered
2020-07-21
Start date
2020-08-01
Completion date
Unknown
Last updated
2020-07-27

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

Conditions

Infection of burn wound

Interventions

30-50% burn area:Cilastatin Sodium
50-80% burn area:Cilastatin Sodium
More than 80% of the burn area:Cilastatin Sodium

Sponsors

The Second People's Hospital of Shenzhen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years, regardless of gender; 2. The total area of burn (flame burn, electric burn, chemical burn, all kinds of hot liquid scald) >= 30%; 3. Patients diagnosed as burn infection according to clinical manifestations, signs and etiological examination; 4. Patients who meet the clinical application of carbapenem antibiotics (severe infection caused by multi drug resistant but sensitive aerobic gram-negative bacilli; severe patients with mixed infection of anaerobic bacteria and aerobic bacteria such as Bacteroides fragilis; experience treatment for patients with severe immune deficiency whose pathogen has not been identified); 5. Patients with no history of mental illness; 6. Patients who did not receive antibiotic treatment within 2 days; 7. Patients who signed the consent form: all subjects voluntarily signed informed consent before the trial; 8. Patients who can persist in completing the treatment course.

Exclusion criteria

Exclusion criteria: 1. Patients allergic to imipenem and cilastatin sodium and other antibiotics; 2. Patients with renal insufficiency; 3. Pregnant women and patients with central nervous system diseases; 4. Patients with epilepsy and mental illness; 5. Patients who are participating in other clinical trials; 6. Patients who are considered unsuitable for clinical trials due to other reasons.

Design outcomes

Primary

MeasureTime frame
Improvement of wound infection in burn patients;Temperature drop in burn patients;The situation of tissue microbial culture in burn wound patients turned negative;

Secondary

MeasureTime frame
Observe the drug concentration of imipenem cilastatin sodium;

Countries

China

Contacts

Public ContactWang Daoxin

The Second People's Hospital of Shenzhen

szwhe@sina.com+86 13662214896

Outcome results

None listed

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