NCT01940731

Efficacy and Safety of Colistimethate Sodium Injection Vial to Treat Hospital-acquired Pneumonia in Adults

A Prospective, Open, Non-controlled, Multi-center Study of Efficacy and Safety of Colistimethate Sodium Injection Vial to Treat Hospital-acquired Pneumonia in Adults.

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

1. To evaluate the clinical and microbiological efficacy and safety of Colistimethate sodium Injection Vial to treat adults with hospital-acquired pneumonia . 2. To Learn the pharmacokinetic characteristics of continuous intravenous infusion of Colistimethate sodium.

Conditions

• Hospital-acquired Pneumonia

Interventions

Type	Name	Description
DRUG	Colistimethate sodium	3-5mg/(kg.d)(if CLcr≥80 mL/min),The maximum dose≤300mg/d 2.5-3.8mg/(kg.d)（if CLcr=50-79mL/min），The maximum dose≤230mg/d twice a day

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-03-01
• First posted: 2013-09-12
• Last updated: 2013-09-12

Locations

5 sites across 1 country: China