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NCT Number: NCT07524920

Comparing Efficacy and Safety of (Meropenem + Colistin) Versus (Imipenem/Cilastatin + Tigecycline) on Eradication of Multi-Drug Resistance Bacteria

This study aims to compare the efficacy and safety of two antibiotic combinations (Colistin + Meropenem) vs (Imipenem/cilastatin+ Tigecycline) in the treatment of adults with MDR gram-negative infections.

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Key information

Conditions

MDR Bacteria

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

Antimicrobial resistance is rapidly becoming a global focus of attention, especially with the rising number of microorganisms resistant to available antimicrobials. It encompasses both the gram-positive and gram-negative bacteria, with global prevalence rates of 60% or more.

Multidrug-resistance is described as acquired non-sensitivity to one or more agents in at least three groups of antimicrobials. This kind of resistance essentially predominates in hospitals , as The Centers for Disease Control and Prevention (CDC) declared that worldwide increasing infection rates with resistant pathogens strikingly endanger our healthcare systems creating both negative universal economic effects and a therapeutic challenge for clinicians hence delaying proper antibiotic therapy and increasing mortality rates.

A retrospective study on the prevalence and antimicrobial susceptibility profile of multidrug-resistant bacteria among intensive care units' patients at Ain Shams University Hospitals in Egypt showed that the majority of pathogens were isolated from blood cultures, with higher prevalence of gram-negative isolates, and Klebsiella sp. being the most common pathogen isolated followed by E. coli.

For complicated infections or hemodynamically unstable patients, it's recommended to administer polymyxins plus another agent to which organism has demonstrated susceptible MIC (like tigecycline, aminoglycosides, IV fosfomycin) or high dose carbapenems if MIC < 16, Ceftazidime-avibactam alone if in-vitro susceptibility has been demonstrated or in combination with aztreonam if synergy test is demonstrating zone of inhibition., Tigecycline is approved for intra-abdominal infection and skin -soft tissue infection- but not highly recommended for blood stream infection or pneumonia as a standalone agent. Colistin is preferred over polymyxin B for UTI as a single agent for uncomplicated infections.

All the suggested treatments are provided as combinations not as a single agent because of the failure of single antibiotic regimens in many trials. and there are also many studies which were based on combination therapy with a few antibiotics showed certain activity against MDR bacteria including colistin, Imipenem/cilastatin , Meropenem, rifampicin, sulbactam and tigecycline.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult and elderly patients (aged 18-85 years)
  • With Clinical and microbiological evidence of infection due to positive or negative multi-drug resistant bacterial culture whatever the cause of patient hospital admission from the beginning.
  • Immunocompromised patient With Clinical and microbiological evidence of infection due to positive or negative multi-drug resistant bacterial culture

Exclusion criteria

  • • History of prior hypersensitivity to the study drugs.
  • Recent fits or CNS events like seizures.
  • Pregnancy and lactation.
  • Bacterial MDR culture but sensitive to one of the antibiotics used in the study

Treatment and study plan

"Imipenem/cilastatin" and "Tigecycline"

Drug

Imipenem/cilastatinis 500mg or 1gm every 6 to 8 hrs , Tigecycline 200 mg loading dose once followed by 100mg BID

"colistin" and "meropenem"

Drug

meropenem IV 2g TID , colistin IV 9M loading then 5M BID

Primary outcomes

  1. Efficacy of Treatment (Laboratory Investigation): Complete blood picture (CBC)

    Time frame: on day 1 , 3 , 5 , 7 , 9 , 11 ,13 ,15 , 17 , 19 , 21 , 23 , 25 , 27 , 29

    1- Complete blood picture (CBC) to check on the success of the antibiotic combination in decreasing the total leucocytic count (TLC)10^3/ul and neutrophiles count (NEUT)10^3/ul.

  2. Efficacy of treatment, (Laboratory Investigation): CRP

    Time frame: on day 3 , 6 , 9 , 12 , 15 , 18 , 21 , 24 , 27 , 30

    to check on the success of the antibiotic combination in decreasing C-reactive protein value (CRP)mg/l

  3. Efficacy of treatment, Bacteriology test (culture)

    Time frame: on day 4 , 11 , 18 , 25

    bacteriology culture is done from the site of infection

  4. Efficacy parameters, Symptoms

    Time frame: on day 1,2,3,4,5,6,7,8,9,10,11,12,13,14,15,16,17,18,19,20,21,22,23,24,25,26,27,28,29,30

    it differs according to source of infection as it could be fever or others according to the source of infection

  5. Emergent adverse event by BUN (mg/dl) , Sr.Cr (mg/dl) and uric acid (mg/dl)

    Time frame: on day 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29

    to check on BUN (mg/dl) , Sr.Cr (mg/dl) and uric acid (mg/dl) values as a kidney function monitoring measures to decide if there is a need for antibiotics dose adjustments

  6. Efficacy of treatment, (Laboratory Investigation): PCT

    Time frame: on day 3 , 7 , 11 , 15 , 19 , 23 , 27

    to check on the success of the antibiotic combination in decreasing Procalcitonin value (PCT) ng/ml

  7. Emergent adverse event by ALT and AST

    Time frame: on day 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29

    to check on ALT (IU/L) , AST (IU/L) values as a liver function monitoring measures to decide if there is a need for antibiotics dose adjustments

Study contacts

Contact information is provided by the study sponsor or research team.

Rana S Fouad, Assistant Professor

CONTACT

[email protected]

01208164247

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 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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