Colistin and Meropenem Versus Amikacin and Meropenem for MDR Gram Negative Bacteria Regarding Efficacy and Safety.

Phase 4Active Not RecruitingNCT07694700

Beni-Suef University100 enrolled

Overview

Objective of this study is to compare the efficacy and safety between combination of colistin and meropenem and combination of amikacin and meropenem for multi-drug-resistant gram-negative bacteria in Intensive Care Unit. In Beni- Suef University Hospital.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

MDR Bacteria

Interventions

Colistimethate sodium for injection, meropenemDRUG

compare the efficacy and safety between combination of colistin and meropenem and combination of amikacin and meropenem for multi-drug-resistant gram-negative bacteria in Intensive Care Unit. In Beni- Suef University Hospital.

Amikacin Injection and meropenemDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Study will include adult patient (male, female). * Patient age from 18 to 70 years. * Patient will be admitted to intensive care unit in study period (six months), who will receive intravenous colistin and meropenem or amikacin and meropenem as antimicrobial drug for treatment their MDR gram negative infection Exclusion Criteria: * Patients are admitted to intensive care unit younger than 18 years or older than 70 years. * 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. * Patients are on any other nephrotoxic drug (vancomycin, NSAIDs, cyclosporine, amphotericin B, etc.)). * Pregnant and lactating women. * Patients refused the consent of the study.

Locations (1)

Beni- Suef University Hospital.

Banī Suwayf, Egypt

Outcomes

Primary Outcomes

clinical cure at 72 hours

Number of participants achieving clinical cure, defined as resolution of fever and improvement of the baseline signs and symptoms of infection without the need to change or escalate antibiotic therapy.

Time frame: 72 hours

Body temperature

Body temperature measured at baseline and 72 hours after initiation of antibiotic therapy.

Time frame: 72 hours

White blood cell count

White blood cell (WBC) count measured at baseline and 72 hours after initiation of antibiotic therapy.

Time frame: 72 hours

Secondary Outcomes

Serum creatinine level

Serum creatinine level measured at baseline and 72 hours after initiation of colistin plus meropenem or amikacin plus meropenem to assess renal function.

Time frame: 72 hours

14- day survival rate

Number of participants who are alive 14 days after initiation of colistin plus meropenem or amikacin plus meropenem therapy.

Time frame: 14 days

Data from ClinicalTrials.gov

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