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NCT Number: NCT07694700

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

MDR Bacteria

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Beni- Suef University Hospital.

Banī Suwayf, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colistimethate sodium for injection, meropenem

Drug

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 meropenem

Drug

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.

Primary outcomes

  1. clinical cure at 72 hours

    Time frame: 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.

  2. Body temperature

    Time frame: 72 hours

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

  3. White blood cell count

    Time frame: 72 hours

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

Secondary outcomes

  1. Serum creatinine level

    Time frame: 72 hours

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

  2. 14- day survival rate

    Time frame: 14 days

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

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

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.

Acronym: MDR

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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