MDR Bacteria
Conditions
Brief 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.
Interventions
DRUGColistimethate sodium for injection, meropenem
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.
DRUGAmikacin Injection and meropenem
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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical cure at 72 hours | 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 | 72 hours | Body temperature measured at baseline and 72 hours after initiation of antibiotic therapy. |
| White blood cell count | 72 hours | White blood cell (WBC) count measured at baseline and 72 hours after initiation of antibiotic therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum creatinine level | 72 hours | Serum creatinine level measured at baseline and 72 hours after initiation of colistin plus meropenem or amikacin plus meropenem to assess renal function. |
| 14- day survival rate | 14 days | Number of participants who are alive 14 days after initiation of colistin plus meropenem or amikacin plus meropenem therapy. |
Countries
Egypt
Outcome results
None listed