NCT02616354

Preliminary Research On Two-step Dosing Of Imipenem/Cilastatin

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Southeast University, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Compared with Imipenem/Cilastatin 2 hours continuous dosing method and two-step dosing method (0.5 hours before enter half dose, after 1.5 hours, the other half of the input dose) of blood drug concentration in the body than the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT \> MIC), blood drug concentration in the body more than 4 times the minimal inhibitory concentrations (MIC) pathogens percent of dosing interval duration (100% fT \> 4 MIC), blood drug concentration peak and the ratio of the minimal inhibitory concentrations (MIC) pathogens (Cmax/MIC), blood drug concentration (Tmax) used in the peak time, used to guide clinical patients with severe infection of Imipenem/Cilastatin usage.

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	Imipenem	Patients in group I received a dose of imipenem/cilastatin 1g each every 8 hours or 0.5g every 6 hours optimized two-step infusion therapy (rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours)

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2015-11-26
• Last updated: 2015-11-26

Locations

1 site across 1 country: China