Infection in ICU
Conditions
Keywords
colistin, Tigecycline, renal impairment
Brief summary
Objective from this study to compare the clinical outcomes and safety between colistin and tigecycline for multi-drug resistant gram negative bacteria.
Detailed description
Study will be in Beni-Suef university hospital. Group I: 66 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 in intensive care unit to treat their MDR infection and group 2 contains 66 patients received intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose in intensive care unit to treat their MDR infection
Interventions
compare the clinical outcomes and safety between colistin and tigecycline for multi-drug-resistant gram-negative bacteria.
DRUGTigecycline
compare the clinical outcomes and safety between colistin and tigecycline for multi-drug-resistant gram-negative bacteria.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Group I: 66 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 in intensive care unit to treat their MDR infection. Group II: 66 patients received intravenous tigecycline100 mg single dose as loading dose, followed by 25-50 mg every 12 hours maintenance dose 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) * age from 18 to 70 years * Patients admitted to intensive care unit in study period (six months) who received intravenous colistin or tigecycline as antimicrobial drug for treatment their MDR gram negative infection.
Exclusion criteria
* Patient admitted to intensive care unit younger than 18 years or older than 70 years. * Liver transplantation patients. * 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. * Patient is on any other nephrotoxic drug (vancomycin, aminoglycosides, NSAIDs, cyclosporine, amphotericin B, etc.). * Pregnant and lactating women. * Patients refused the consent of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| comparison clinical success between colistin and tigecycline | 6 months | the disappearance of clinical signs and symptoms as normalization of leukocyte counts and resolution of fever after receiving colistin and tigecycline |
Countries
Egypt
Outcome results
None listed