Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline

Phase 4

Active, not recruiting

• Conditions: Infection in ICU
• Interventions: Drug: Colistimethate Sodium; Drug: Tigecycline

• Registration Number: NCT06893835
• Lead Sponsor: Beni-Suef University

Brief 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

Study Timeline

• Study Start: 2024-12-01
• Status Verified: 2025-02
• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-18
• Last Update Submitted: 2025-03-18
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colistin	Colistimethate Sodium	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. Reconstitute each vial of CBA with 2 ml of sterile water for injection, swirl gently. further dilute in normal saline.
Tigecycline	Tigecycline	intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose. add 5.3 ml normal saline to each 50 ml vial. swirl gently. further dilution to final concentration does not exceed 1mg/ml.

Primary Outcome Measures

Name	Time	Method
comparison clinical success between colistin and tigecycline	6 months	the disappearance of clinical signs and symptoms as normalization of leukocyte counts and resolution of fever after receiving colistin and tigecycline

Trial Locations

Locations (1)

Pharmacy; 🇪🇬 Cairo, Egypt