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

Ain Shams University

Status and phase: Active, not recruiting; Phase 2; Phase 1

Conditions: Sepsis

Treatments: Drug: Meropenem I.V. 2g as a 3 hour infusion every 8 hours; Drug: Tazocin (pipercillin/tazobactam)

Study type: Interventional

Funder types: Other

Identifiers

NCT07096310

FMASU MD326/2023

Details and patient eligibility

About

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).

Full 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 .

Enrollment: 400 estimated patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

400 participants in 2 patient groups

Meronem group

Active Comparator group

Description:

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

Treatment:

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

Tazocin group

Active Comparator group

Description:

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

Treatment:

Drug: Tazocin (pipercillin/tazobactam)