MDR BacteriaPhase 2NCT07524920
Comparing Efficacy and Safety of (Meropenem + Colistin) Versus (Imipenem/Cilastatin + Tigecycline) on Eradication of Multi-Drug Resistance Bacteria
A Phase 2 study testing "Imipenem/cilastatin" and "Tigecycline" and "colistin" and "meropenem" in people with MDR Bacteria, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- MDR Bacteria
- What is being tested?
- "Imipenem/cilastatin" and "Tigecycline" and "colistin" and "meropenem"
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 1 Sep 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- • 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
El-Demerdash hospital
Cairo
Haya L Sayed, B.Sc, 01065247885, haya.labeeb@pharma.asu.edu.eg
Rana S Fouad, Assistant Professor, 01208164247, ranasayed@pharma.asu.edu.eg
About this study
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.
Read the 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.
- Conditions
- MDR Bacteria
- Being tested
- "Imipenem/cilastatin" and "Tigecycline", "colistin" and "meropenem"
- Keywords
- MDR, colistin + meropenem, Imipenem/cilastatin+ Tigecycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"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
| Study group | Role | What they receive |
|---|---|---|
| "colistin" and "meropenem" | Experimental | 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. Receives: Drug: "colistin" and "meropenem" |
| "Imipenem/cilastatin" and "Tigecycline" | Experimental | 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. Receives: Drug: "Imipenem/cilastatin" and "Tigecycline" |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Treatment (Laboratory Investigation): Complete blood picture (CBC)
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.
Measured: on day 1 , 3 , 5 , 7 , 9 , 11 ,13 ,15 , 17 , 19 , 21 , 23 , 25 , 27 , 29
Efficacy of treatment, (Laboratory Investigation): CRP
to check on the success of the antibiotic combination in decreasing C-reactive protein value (CRP)mg/l
Measured: on day 3 , 6 , 9 , 12 , 15 , 18 , 21 , 24 , 27 , 30
Efficacy of treatment, Bacteriology test (culture)
bacteriology culture is done from the site of infection
Measured: on day 4 , 11 , 18 , 25
Efficacy parameters, Symptoms
it differs according to source of infection as it could be fever or others according to the source of infection
Measured: 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)
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
Measured: on day 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29
Efficacy of treatment, (Laboratory Investigation): PCT
to check on the success of the antibiotic combination in decreasing Procalcitonin value (PCT) ng/ml
Measured: on day 3 , 7 , 11 , 15 , 19 , 23 , 27
Emergent adverse event by ALT and AST
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
Measured: on day 1,3,5,7,9,11,13,15,17,19,21,23,25,27,29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MDR BacteriaStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rana Sayed Fouad, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07524920
- Sponsor's protocol ID
- CompCombABMDR REC 49
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy and Safety of (Meropenem + Colistin) Versus (Imipenem/Cilastatin + Tigecycline) on Eradication of Multi-Drug Resistance Bacteria
- ClinicalTrials.gov ID
- NCT07524920
- Acronym / sponsor ID
- CompCombABMDR REC 49
- Conditions
- MDR Bacteria
- Keywords
- MDR, colistin + meropenem, Imipenem/cilastatin+ Tigecycline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| "colistin" and "meropenem" | Experimental | Drug: "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. |
| "Imipenem/cilastatin" and "Tigecycline" | Experimental | Drug: "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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- • History of prior hypersensitivity to the study drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Imipenem/cilastatin" and "Tigecycline"Imipenem/cilastatinis 500mg or 1gm every 6 to 8 hrs , Tigecycline 200 mg loading dose once followed by 100mg BID | Drug | "Imipenem/cilastatin" and "Tigecycline" |
| "colistin" and "meropenem"meropenem IV 2g TID , colistin IV 9M loading then 5M BID | Drug | "colistin" and "meropenem" |
Primary outcome
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.
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
Efficacy of treatment, Bacteriology test (culture)
Time frame: on day 4 , 11 , 18 , 25
bacteriology culture is done from the site of infection
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Centers for Disease Control and Prevention. Antibiotic resistance threats in the United States. Atlanta: U.S. Department of health and human services, CDC; 2019.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for MDR Bacteria
Active, not recruitingPhase 4
Colistin and Meropenem Versus Amikacin and Meropenem for MDR Gram Negative Bacteria Regarding Efficacy and Safety.
MDR Bacteria
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing "Imipenem/cilastatin" and "Tigecycline" and "colistin" and "meropenem" in people with MDR Bacteria, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rana S Fouad, Assistant Professor (01208164247, ranasayed@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.