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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| amikacin and meropenem | Active Comparator | 50 patients received intravenous amikacin 15 to 30 mg/kg once daily and intravenous meropenem 2gm every 8hrs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colistimethate sodium for injection, meropenem | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
| Body temperature | Body temperature measured at baseline and 72 hours after initiation of antibiotic therapy. | 72 hours |
| White blood cell count | White blood cell (WBC) count measured at baseline and 72 hours after initiation of antibiotic therapy. | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 72 hours |
| 14- day survival rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beni- Suef University Hospital. | Banī Suwayf | Egypt |
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|
| Amikacin Injection and meropenem | Drug | 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. |
|
Number of participants who are alive 14 days after initiation of colistin plus meropenem or amikacin plus meropenem therapy.
| 14 days |
| ID | Term |
|---|---|
| C004691 | colistinmethanesulfonic acid |
| D007267 | Injections |
| D000077731 | Meropenem |
| D000583 | Amikacin |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D013845 | Thienamycins |
| D015780 | Carbapenems |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D007612 | Kanamycin |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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