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

Comparative Study of Efficacy and Safety Between Combination of Colistin and Meropenem and Combination of Amikacin and Meropenem for Multi-Drug-Resistant Gram-Negative Bacteria.

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 Overview

• Status: Active, not recruiting
• Conditions: MDR Bacteria
• Intervention / Treatment: Drug: Colistimethate sodium for injection, meropenem; Drug: Amikacin Injection and meropenem

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Banī Suwayf, Egypt
    • Beni- Suef University Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: colistin and meropenem; 50 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 and intravenous meropenem 2gm every 8hrs	Drug: Colistimethate sodium for injection, meropenem; 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.
Active Comparator: amikacin and meropenem; 50 patients received intravenous amikacin 15 to 30 mg/kg once daily and intravenous meropenem 2gm every 8hrs	Drug: Amikacin Injection and meropenem; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	72 hours
Body temperature	Body temperature measured at baseline and 72 hours after initiation of antibiotic therapy.	72 hours
White blood cell count	White blood cell (WBC) count measured at baseline and 72 hours after initiation of antibiotic therapy.	72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	14 days

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): December 30, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: June 28, 2026
• First Submitted That Met QC Criteria: July 4, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 4, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Organic Chemicals; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Administration Routes; Drug Therapy; Carbohydrates; Glycosides; Amides; Aminoglycosides; beta-Lactams; Lactams; Carbapenems; Thienamycins; Kanamycin; Meropenem; Amikacin; Injections; colistinmethanesulfonic acid
• Other Study ID Numbers: colistin, amikacin, in MDR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No