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

April 6, 2026 updated by: Rana Sayed Fouad, Ain Shams University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "colistin" and "meropenem"
30 patients will receive a combination of "Meropenem" and "colistin", normal dose of Meropenem is 2gm/8hrs and normal dose of colistin is loading dose 9 million units once followed by 5million units/12hrs for about 5-14 days period.
Drug: "colistin" and "meropenem"
meropenem IV 2g TID , colistin IV 9M loading then 5M BID
Experimental: "Imipenem/cilastatin" and "Tigecycline"
30 patients will receive a combination of "Imipenem/cilastatin" and "Tigecycline", normal dose of Imipenem/cilastatinis 500mg or 1gm every 6 to 8 hrs and normal dose of Tigecyclineis 200 mg loading dose once followed by 100mg/12hrs as maintenance dose for about 5-14 days period.
Drug: "Imipenem/cilastatin" and "Tigecycline"
Imipenem/cilastatinis 500mg or 1gm every 6 to 8 hrs , Tigecycline 200 mg loading dose once followed by 100mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
on day 1 , 3 , 5 , 7 , 9 , 11 ,13 ,15 , 17 , 19 , 21 , 23 , 25 , 27 , 29
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
on day 3 , 6 , 9 , 12 , 15 , 18 , 21 , 24 , 27 , 30
Efficacy of treatment, Bacteriology test (culture)
Time Frame: on day 4 , 11 , 18 , 25
bacteriology culture is done from the site of infection
on day 4 , 11 , 18 , 25
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
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
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
on day 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29
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
on day 3 , 7 , 11 , 15 , 19 , 23 , 27
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
on day 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 6, 2026

First Posted (Actual)

April 13, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CompCombABMDR REC 49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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