Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline (MDRS)

Beni-Suef University

Status and phase: Active, not recruiting; Phase 4

Conditions: Infection in ICU

Treatments: Drug: Colistimethate Sodium; Drug: Tigecycline

Study type: Interventional

Funder types: Other

Identifiers

NCT06893835

Multidrug resistance

Details and patient eligibility

About

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

Full 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

Enrollment: 132 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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132 participants in 2 patient groups

Colistin

Active Comparator group

Description:

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.

Treatment:

Drug: Colistimethate Sodium

Tigecycline

Active Comparator group

Description:

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.

Treatment:

Drug: Tigecycline