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Active, not recruiting Phase 1/2

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

NCT07096310 · tracked via the Priya Life Science Egypt tracker
Phase
Phase 1/2
Started
2024-01-01
Last updated
2025-10-03

Condition(s) studied

Sepsis

Investigational drug(s) / intervention(s)

Meropenem I.V. 2g as a 3 hour infusion every 8 hoursTazocin (pipercillin/tazobactam)

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

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

Study 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).

Eligibility

Sex
ALL
Min age
21 Years
Max age
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.

Primary outcome measure(s)

  • 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.

Trial sites (1)

FacilityCityRegionStatus
Ain Shams University Hospitals Cairo Egypt
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07096310 on ClinicalTrials.gov ↗ ← All trials in Egypt