Status:
ACTIVE_NOT_RECRUITING
Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline
Lead Sponsor:
Beni-Suef University
Conditions:
Infection in ICU
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
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 d...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Study will include
- adult patient (male, female)
- age from 18 to 70 years
- Patients admitted to intensive care unit in study period (six months) who received intravenous colistin or tigecycline as antimicrobial drug for treatment their MDR gram negative infection.
- Exclusion criteria:
- Patient admitted to intensive care unit younger than 18 years or older than 70 years.
- Liver transplantation patients.
- Patients are chronic kidney disease (CKD on hemodialysis or baseline creatinine clearance (crcl) \< 10 ml/min (estimated by Cockcroft Gault equation).
- Patients received renal replacement therapy before or during admission.
- Patient is on any other nephrotoxic drug (vancomycin, aminoglycosides, NSAIDs, cyclosporine, amphotericin B, etc.).
- Pregnant and lactating women.
- Patients refused the consent of the study.
Exclusion
Key Trial Info
Start Date :
December 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06893835
Start Date
December 1 2024
End Date
June 30 2025
Last Update
March 25 2025
Active Locations (1)
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1
Pharmacy
Cairo, Egypt