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

NCT07096310 | Active Not Recruiting Phase 1 FDA Drug

• 1 other identifier: FMASU MD326/2023
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Sepsis

Keywords

Meronem; Tazocin; sepsis; Burn

Outcome Measures

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.

  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.

  2 weeks

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).

  2 weeks

Study Arms (2)

Meronem group

ACTIVE COMPARATOR

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

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

Tazocin group

ACTIVE COMPARATOR

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

Drug: Tazocin (pipercillin/tazobactam)

Interventions

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

Also known as: Meronem

Meronem group

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

Also known as: Zocin

Tazocin group

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Hospitals

Cairo, 002, Egypt

Location

Related Publications (6)

• Rhodes NJ, Wagner JL, Davis SL, Bosso JA, Goff DA, Rybak MJ, Scheetz MH; MAD-ID Research Network. Trends in and Predictors of Carbapenem Consumption across North American Hospitals: Results from a Multicenter Survey by the MAD-ID Research Network. Antimicrob Agents Chemother. 2019 Jun 24;63(7):e00327-19. doi: 10.1128/AAC.00327-19. Print 2019 Jul.

  PMID: 31061154 BACKGROUND

• Fleischmann-Struzek C, Mellhammar L, Rose N, Cassini A, Rudd KE, Schlattmann P, Allegranzi B, Reinhart K. Incidence and mortality of hospital- and ICU-treated sepsis: results from an updated and expanded systematic review and meta-analysis. Intensive Care Med. 2020 Aug;46(8):1552-1562. doi: 10.1007/s00134-020-06151-x. Epub 2020 Jun 22.

  PMID: 32572531 BACKGROUND

• Ibrahim EH, Sherman G, Ward S, Fraser VJ, Kollef MH. The influence of inadequate antimicrobial treatment of bloodstream infections on patient outcomes in the ICU setting. Chest. 2000 Jul;118(1):146-55. doi: 10.1378/chest.118.1.146.

  PMID: 10893372 BACKGROUND

• Umemura Y, Yamakawa K, Tanaka Y, Yoshimura J, Ogura H, Fujimi S. Efficacy of Carbapenems Compared With Noncarbapenem Broad-Spectrum Beta-Lactam Antibiotics as Initial Antibiotic Therapy Against Sepsis: A Nationwide Observational Study. Crit Care Med. 2023 Sep 1;51(9):1210-1221. doi: 10.1097/CCM.0000000000005932. Epub 2023 May 26.

  PMID: 37232855 BACKGROUND

• Evans L, Rhodes A, Alhazzani W, Antonelli M, Coopersmith CM, French C, Machado FR, Mcintyre L, Ostermann M, Prescott HC, Schorr C, Simpson S, Wiersinga WJ, Alshamsi F, Angus DC, Arabi Y, Azevedo L, Beale R, Beilman G, Belley-Cote E, Burry L, Cecconi M, Centofanti J, Coz Yataco A, De Waele J, Dellinger RP, Doi K, Du B, Estenssoro E, Ferrer R, Gomersall C, Hodgson C, Moller MH, Iwashyna T, Jacob S, Kleinpell R, Klompas M, Koh Y, Kumar A, Kwizera A, Lobo S, Masur H, McGloughlin S, Mehta S, Mehta Y, Mer M, Nunnally M, Oczkowski S, Osborn T, Papathanassoglou E, Perner A, Puskarich M, Roberts J, Schweickert W, Seckel M, Sevransky J, Sprung CL, Welte T, Zimmerman J, Levy M. Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021. Intensive Care Med. 2021 Nov;47(11):1181-1247. doi: 10.1007/s00134-021-06506-y. Epub 2021 Oct 2. No abstract available.

  PMID: 34599691 BACKGROUND

• Abe T, Ogura H, Shiraishi A, Kushimoto S, Saitoh D, Fujishima S, Mayumi T, Shiino Y, Nakada TA, Tarui T, Hifumi T, Otomo Y, Okamoto K, Umemura Y, Kotani J, Sakamoto Y, Sasaki J, Shiraishi SI, Takuma K, Tsuruta R, Hagiwara A, Yamakawa K, Masuno T, Takeyama N, Yamashita N, Ikeda H, Ueyama M, Fujimi S, Gando S; JAAM FORECAST group. Characteristics, management, and in-hospital mortality among patients with severe sepsis in intensive care units in Japan: the FORECAST study. Crit Care. 2018 Nov 22;22(1):322. doi: 10.1186/s13054-018-2186-7.

  PMID: 30466493 BACKGROUND

MeSH Terms

Conditions

Sepsis; Burns

Interventions

Meropenem; Piperacillin, Tazobactam Drug Combination; Piperacillin; Tazobactam

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Thienamycins; Carbapenems; beta-Lactams; Lactams; Amides; Organic Chemicals; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Penicillanic Acid; Penicillins; Ampicillin; Penicillin G; Sulfur Compounds; Sulfones; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Mohamed A Ali, MD

  Ain Shams University

  STUDY CHAIR

• Osama R Abdelmalek, MD

  Ain Shams University

  STUDY DIRECTOR

• Thabet A Botros, MD

  Ain Shams University

  STUDY DIRECTOR

• Aya A Bayoumy, MD

  Ain Sham University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anesthesia and ICU

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

Study Record Dates

• First Submitted: July 4, 2025
• First Posted: July 31, 2025
• Study Start: January 1, 2024
• Primary Completion: January 15, 2026
• Study Completion: March 1, 2026
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)