MDR BacteriaPhase 4MDRNCT07694700
Colistin and Meropenem Versus Amikacin and Meropenem for MDR Gram Negative Bacteria Regarding Efficacy and Safety.
A Phase 4 study testing Colistimethate sodium for injection, meropenem and Amikacin Injection and meropenem in people with MDR Bacteria, run by Beni-Suef University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- MDR Bacteria
- What is being tested?
- Colistimethate sodium for injection, meropenem and Amikacin Injection and meropenem
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Dec 2025to 30 Sep 2026
- Phase
- Phase 4
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
- Conditions
- MDR Bacteria
- Being tested
- Colistimethate sodium for injection, meropenem, Amikacin Injection and meropenem
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colistimethate sodium for injection, meropenemDrug
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 meropenemDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| colistin and meropenem | Active comparator | 50 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose and intravenous meropenem 2gm every 8hrs Receives: Drug: Colistimethate sodium for injection, meropenem |
| amikacin and meropenem | Active comparator | 50 patients received intravenous amikacin 15 to 30 mg/kg once daily and intravenous meropenem 2gm every 8hrs Receives: Drug: Amikacin Injection and meropenem |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical cure at 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.
Measured: 72 hours
Body temperature
Body temperature measured at baseline and 72 hours after initiation of antibiotic therapy.
Measured: 72 hours
White blood cell count
White blood cell (WBC) count measured at baseline and 72 hours after initiation of antibiotic therapy.
Measured: 72 hours
Secondary outcomes (2)
Serum creatinine level
Serum creatinine level measured at baseline and 72 hours after initiation of colistin plus meropenem or amikacin plus meropenem to assess renal function.
Measured: 72 hours
14- day survival rate
Number of participants who are alive 14 days after initiation of colistin plus meropenem or amikacin plus meropenem therapy.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2026
- Study start30 Dec 2025
- Primary completion30 Aug 2026 (estimated)
- Study completion30 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 Beni-Suef 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * Group I: 50 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose (7) and intravenous meropenem 2gm every 8hrs in intensive care unit to treat their MDR infection, this group will be the control group.Click or tap here to enter text. * Group II: 50 patients received intravenous amikacin 15 to 30 mg/kg once daily (8) and intravenous meropenem 2gm every 8hrs (9) in intensive care unit to treat their MDR infection.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Nafady Abdelfattah, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07694700
- Sponsor's protocol ID
- colistin, amikacin, in MDR
- Acronym
- MDR
- Status last verified
- Jul 2026
- First submitted
- 28 Jun 2026
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07694700
- Acronym / sponsor ID
- MDR / colistin, amikacin, in MDR
- Conditions
- MDR Bacteria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 10 Jul 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * Group I: 50 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose (7) and intravenous meropenem 2gm every 8hrs in intensive care unit to treat their MDR infection, this group will be the control group.Click or tap here to enter text. * Group II: 50 patients received intravenous amikacin 15 to 30 mg/kg once daily (8) and intravenous meropenem 2gm every 8hrs (9) in intensive care unit to treat their MDR infection.
| Arm | Type | Receives |
|---|---|---|
| colistin and meropenem | Active comparator | Drug: Colistimethate sodium for injection, meropenem50 patients received intravenous colistin 300 mg colistin base activity (CBA) as loading dose, followed by 2.5-5mg/kg/day of CBA in 2 divided doses as a maintenance dose and intravenous meropenem 2gm every 8hrs |
| amikacin and meropenem | Active comparator | Drug: Amikacin Injection and meropenem50 patients received intravenous amikacin 15 to 30 mg/kg once daily and intravenous meropenem 2gm every 8hrs |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
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 |
|---|---|---|
| Colistimethate sodium for injection, meropenemcompare 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. | Drug | colistin and meropenem |
| Amikacin Injection and meropenemcompare 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. | Drug | amikacin and meropenem |
Primary outcome
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.
Body temperature
Time frame: 72 hours
Body temperature measured at baseline and 72 hours after initiation of antibiotic therapy.
White blood cell count
Time frame: 72 hours
White blood cell (WBC) count measured at baseline and 72 hours after initiation of antibiotic therapy.
2 secondary outcomes
Serum creatinine level
Time frame: 72 hours
14- day survival rate
Time frame: 14 days
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 14 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Colistimethate sodium for injection, meropenem and Amikacin Injection and meropenem in people with MDR Bacteria, run by Beni-Suef 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 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical cure at 72 hours (time frame: 72 hours). The study lists 3 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 14 Jul 2026.