SepsisPhase 1/2NCT07096310
Comparison Between Carbapenems and Noncarbapenem Beta-lactam Antibiotics in Septic Burn Patients
A Phase 1/2 study testing Meropenem I.V. 2g as a 3 hour infusion every 8 hours and Tazocin (pipercillin/tazobactam) in people with Sepsis, run by Ain Shams University at 1 site in Egypt.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Sepsis
- What is being tested?
- Meropenem I.V. 2g as a 3 hour infusion every 8 hours and Tazocin (pipercillin/tazobactam)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 1 Mar 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Carbapenems and Noncarbapenem Broad Spectrum Beta-lactam Antibiotics as Initial Antibiotic Therapy Against Sepsis in Burn Patients: A Prospective Study
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).
Read the detailed 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 .
- Conditions
- Sepsis
- Being tested
- Meropenem I.V. 2g as a 3 hour infusion every 8 hours, Tazocin (pipercillin/tazobactam)
- Keywords
- Meronem, Tazocin, sepsis, Burn
- Medical subject headings
- Sepsis, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meropenem I.V. 2g as a 3 hour infusion every 8 hoursDrug
Also called Meronem
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)Drug
Also called Zocin
Non C group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day
| Study group | Role | What they receive |
|---|---|---|
| Meronem group | Active comparator | Meronem group will receive Meronem 2 gm Iv infusion over 3 hours every 8 hours per day Receives: 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 Receives: Drug: Tazocin (pipercillin/tazobactam) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Occurrence rate of enterocolitis due to Clostridium difficile.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Jan 2024
- Primary completion15 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- each drug will be given to every group according to dose according to Patient weight per KG
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Mohamed Mohamed Abdelfattah, Ain Shams University
- Investigators
- Mohamed A Ali, MD, Study chair, Ain Shams UniversityOsama R Abdelmalek, MD, Study director, Ain Shams UniversityThabet A Botros, MD, Study director, Ain Shams UniversityAya A Bayoumy, MD, Study director, Ain Sham University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096310
- Sponsor's protocol ID
- FMASU MD326/2023
- Status last verified
- Sep 2025
- First submitted
- 4 Jul 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data Available with the corresponding author on visible request this is for patients privacy
Publications
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.
PubMed 31061154Fleischmann-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.
PubMed 32572531Ibrahim 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.
PubMed 10893372Umemura 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.
PubMed 37232855Evans 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.
PubMed 34599691Abe 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.
PubMed 30466493
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Carbapenems and Noncarbapenem Broad Spectrum Beta-lactam Antibiotics as Initial Antibiotic Therapy Against Sepsis in Burn Patients: A Prospective Study
- ClinicalTrials.gov ID
- NCT07096310
- Acronym / sponsor ID
- FMASU MD326/2023
- Conditions
- Sepsis
- Keywords
- Meronem, Tazocin, sepsis, Burn
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 15 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 31 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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 .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- each drug will be given to every group according to dose according to Patient weight per KG
| Arm | Type | Receives |
|---|---|---|
| Meronem group | Active comparator | Drug: Meropenem I.V. 2g as a 3 hour infusion every 8 hoursMeronem group will receive Meronem 2 gm Iv infusion over 3 hours every 8 hours per day |
| Tazocin group | Active comparator | Drug: Tazocin (pipercillin/tazobactam)Tazocin group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meropenem I.V. 2g as a 3 hour infusion every 8 hoursAlso: MeronemNon C group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day | Drug | Meronem group |
| Tazocin (pipercillin/tazobactam)Also: ZocinNon C group will receive non Carbapenems (Tazocin) 4.5 gm IV slow infusion over 20 minutes every 8 hours per day | Drug | Tazocin group |
Primary outcome
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.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 31061154Rhodes 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.
- Background: PubMed 32572531Fleischmann-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.
- Background: PubMed 10893372Ibrahim 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.
- Background: PubMed 37232855Umemura 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.
- Background: PubMed 34599691Evans 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.
- Background: PubMed 30466493Abe 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.
- Individual participant dataSharing planned: No. Data Available with the corresponding author on visible request this is for patients privacy
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed A Ali, MD study chair
Ain Shams University
Osama R Abdelmalek, MD study director
Ain Shams University
Thabet A Botros, MD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Meropenem I.V. 2g as a 3 hour infusion every 8 hours and Tazocin (pipercillin/tazobactam) in people with Sepsis, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07096310, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.