Comparison Between Carbapenems and Noncarbapenem Beta-lactam Antibiotics in Septic Burn Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-03-01

Brief Summary

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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).

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Detailed Description

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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 .

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

each drug will be given to every group according to dose according to Patient weight per KG

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Meronem group

Meronem group will receive Meronem 2 gm Iv infusion over 3 hours every 8 hours per day

Group Type ACTIVE_COMPARATOR

Meropenem I.V. 2g as a 3 hour infusion every 8 hours

Intervention Type DRUG

Non C group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day

Tazocin group

Tazocin group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day

Group Type ACTIVE_COMPARATOR

Tazocin (pipercillin/tazobactam)

Intervention Type DRUG

Non C group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day

Interventions

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Meropenem 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

Intervention Type DRUG

Tazocin (pipercillin/tazobactam)

Non C group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day

Intervention Type DRUG

Other Intervention Names

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Meronem Zocin

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No