Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Explore Imipenem/Cilastatin two-step dosing compared to 2 hours infusion in patients with severe whether can obtain better results of the pharmacokinetic/pharmacodynamic, for clinical rational use of antimicrobial agents, and provide theoretical support for optimizing dosage regimen.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southeast University, China
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Cilastatin; Imipenem

Criteria

Inclusion Criteria:

• sepsis or severe sepsis or severe infections in the previous 48 hours

• treatment with imipenem/cilastatin (recommended by hospital microbiologists)

• expected duration of hospital stays in the ICU ≥ 72 h from recruitment

• recruited patients agreed to participate in this trial, and had set up a signed informed consent

Exclusion Criteria:

• with an allergy to carbapenems or with an adverse drug reaction to imipenem

• acute or chronic renal failure assessed by serum creatinine concentrations > 280 μmol/L (or creatinine clearance <20mL/min) or those requiring continuous renal replacement therapy

• drug or alcohol abuse

• Pregnant and lactant women

• patients near to death