Sepsis
Conditions
Keywords
Meronem, Tazocin, sepsis, Burn
Brief summary
The aim of this work is to evaluate the efficacy associated with Meropenem(example of carbapenems) as initial therapy for sepsis in burn patients compared with Pipracillin/Tazobactam (example of non carbapenem beta lactam antibiotics).
Detailed description
As causative pathogens are not usually identified at the time of initiating antibiotics in sepsis in burn patients, carbapenems are commonly used as an initial treatment. To reduce indiscriminate use of carbapenems, the efficacy of alternative empiric regimens, such as piperacillin-tazobactam and the fourth-generation cephalosporins, should be elucidated. The aim of this study is to compare efficacy of Meropenem and piperacillin tazobactam as an initial therapy of sepsis in burn patients .
Interventions
DRUGMeropenem I.V. 2g as a 3 hour infusion every 8 hours
Non C group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day
Non C group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
each drug will be given to every group according to dose according to Patient weight per KG
Eligibility
Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Burned patients admitted to Burn Unit of Ain Shams university hospitals diagnosed with sepsis, not transferred from other hospitals, Age group between 21 - 60 years old, ASA I and II.
Exclusion criteria
* Refusal of participation in the study, * Patient with no signs of sepsis, * Patients who died within 24 hours after admission, * Patients concomitantly received carbapenems and other broad-spectrum beta-lactams, * Data from the second and subsequent hospitalizations of patients who were hospitalized multiple times during the study period and used only the data from the first hospitalization, * Patients younger than 21 years old and older than 60 years old.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is to evaluate survival rate associated with carbapenems as initial therapy for sepsis in burn patients compared with non carbapenem antibiotics by comparing SOFA score between two groups. | 2 weeks | The primary outcome of this work is to evaluate rate of survival associated with carbapenems as initial therapy for sepsis in burn patients compared with non carbapenem antibiotics by measuring SOFA score at day 4 and day 7 of starting of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence rate of enterocolitis due to Clostridium difficile. (rate of patients with diarrhea and stool culture shows Clostridium difficile in each group). | 2 weeks | Occurrence rate of enterocolitis due to Clostridium difficile. |
Countries
Egypt
Outcome results
None listed