Not Yet RecruitingPhase 2

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

Egypt60 participantsStarted 2026-04-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 85 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

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

Efficacy of treatment, (Laboratory Investigation): CRP

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

Efficacy of treatment, Bacteriology test (culture)

Timeframe: on day 4 , 11 , 18 , 25

Efficacy parameters, Symptoms

Timeframe: 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)

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

Efficacy of treatment, (Laboratory Investigation): PCT

Timeframe: on day 3 , 7 , 11 , 15 , 19 , 23 , 27

Emergent adverse event by ALT and AST

Trial details

NCT IDNCT07524920

SponsorAin Shams University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-01

Contact for this trial

Rana S Fouad, Assistant Professor

01208164247 ranasayed@pharma.asu.edu.eg

View on ClinicalTrials.gov More MDR Bacteria trials