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NCT Number: NCT07096310

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

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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This study is active but is not currently recruiting participants.

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Key information

Conditions

Sepsis Burns Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome Wounds and Injuries

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Ain Shams University Hospitals

Cairo, 002, Egypt

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Other names: Meronem

Tazocin (pipercillin/tazobactam)

Drug

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

Other names: Zocin

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Occurrence rate of enterocolitis due to Clostridium difficile. (rate of patients with diarrhea and stool culture shows Clostridium difficile in each group).

    Time frame: 2 weeks

    Occurrence rate of enterocolitis due to Clostridium difficile.

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Comparison Between Carbapenems and Noncarbapenem Broad Spectrum Beta-lactam Antibiotics as Initial Antibiotic Therapy Against Sepsis in Burn Patients: A Prospective Study

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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