NCT06893835

Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline

Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline for Multi-Drug Resistant Gram Negative Bacteria

• Status: Active Not Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 132 (estimated)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Objective from this study to compare the clinical outcomes and safety between colistin and tigecycline for multi-drug resistant gram negative bacteria.

Detailed description

Study will be in Beni-Suef university hospital. Group I: 66 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose in intensive care unit to treat their MDR infection and group 2 contains 66 patients received intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose in intensive care unit to treat their MDR infection

Conditions

• Infection in ICU

Interventions

Type	Name	Description
DRUG	Colistimethate Sodium	compare the clinical outcomes and safety between colistin and tigecycline for multi-drug-resistant gram-negative bacteria.
DRUG	Tigecycline	compare the clinical outcomes and safety between colistin and tigecycline for multi-drug-resistant gram-negative bacteria.

Timeline

• Start date: 2024-12-01
• Primary completion: 2025-05-30
• Completion: 2025-06-30
• First posted: 2025-03-25
• Last updated: 2025-03-25

Locations

1 site across 1 country: Egypt