Comparing piperacillin-tazobactam and meropenem for treating bloodstream infections caused by cephalosporin-resistant bacteria in adult patients

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What is this study about?

This study focuses on treating bloodstream infections (bacteremia) caused by specific bacteria that are resistant to certain antibiotics. The research compares two different antibiotic treatments: piperacillin-tazobactam and meropenem. The bacteria being studied include several types that commonly cause infections in the blood, such as Escherichia coli, Klebsiella species, and other related bacteria that have developed resistance to commonly used antibiotics.

The purpose of this research is to determine if piperacillin-tazobactam works as effectively as meropenem in treating these resistant blood infections. Both medications are given through an intravenous infusion, which means they are administered directly into the bloodstream. Piperacillin-tazobactam can be given up to 18 grams per day, while meropenem can be given up to 3 grams per day.

During the study, patients will receive one of these two antibiotic treatments. The doctors will monitor how well the infection responds to treatment, checking for signs of improvement or failure over several months. They will also watch for any side effects and track whether the infection returns. The study will look at various outcomes, including how long patients need to stay in the hospital and whether they develop any new infections during the treatment period.

1 Initial blood test confirmation

Your blood test has shown an infection caused by specific bacteria that are resistant to some antibiotics but can be treated with either of the study medications.

The infection type being treated is called bacteremia, which means bacteria are present in your blood.

2 Random assignment to treatment group

You will be randomly assigned to receive one of two medications:

– Meropenem: given as a 2g solution through injection or infusion

– Piperacillin/Tazobactam: given as a 2g/0.25g solution through infusion

3 Treatment period

You will receive the assigned medication for at least 7 days

Your doctor will monitor your response to treatment and may adjust the treatment if necessary

4 Follow-up evaluations

Your health will be monitored at specific intervals: 7, 14, 30, and 90 days after starting treatment

During these check-ups, you will be evaluated for:

– Response to treatment

– Any new infections

– Possible side effects

– Development of antibiotic resistance

5 Extended monitoring

Your health will continue to be monitored for up to 90 days to check for:

– Any return of infection

– New infections

– Hospital readmissions if needed

– Total days of antibiotic use

The study will record any hospital stays required during this period

Who Can Join the Study?

Must be 18 years of age or older
Must have a newly diagnosed bloodstream infection (infection present in the blood) caused by specific bacteria:
- E. coli
- Klebsiella species
- Serratia marcescens
- Providencia species
- Morganella morganii
- Citrobacter freundii
- Enterobacter species
The bacteria causing the infection must be:
- Resistant to certain antibiotics called third-generation cephalosporins (specifically ceftriaxone and ceftazidime)
- Able to be treated with antibiotics called PTZ and meropenem
Can have an infection that started either:
- In the community (outside the hospital)
- In the hospital
Can participate if other harmless skin bacteria are found in the blood test along with the infection-causing bacteria
Both men and women can participate

Who Cannot Join the Study?

Patient is under 18 years of age
Patient has a known severe allergy to meropenem or piperacillin-tazobactam (antibiotics used in the study)
Patient has a severe kidney impairment requiring dialysis
Patient is pregnant or breastfeeding
Patient has other types of bacteria in the blood than those specified for the study (E. coli, Klebsiella, Serratia, Providencia, Morganella, Citrobacter, or Enterobacter)
Patient has received more than 24 hours of effective antibiotic treatment before enrollment
Patient has a severe immune system disorder
Patient is participating in another clinical trial
Patient is unable to provide informed consent
Patient has a condition that would make it unsafe to participate in the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
National Institute For Infectious Diseases Lazzaro Spallanzani	Rome	Italy
Azienda Socio Sanitaria Territoriale Di Cremona	Cremona	Italy
ASST Fatebenefratelli Sacco	Milan	Italy
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universita’ Di Pisa	Pisa	Italy
Azienda Sociosanitaria Territoriale Santi Paolo E Carlo	Milan	Italy
Ahpzeib Uhjmd Sxeqxoqdy Loykou Dc Bpptvms	Bologna	Italy
Uraqiorpph Dysox Shirt Dr Rcgb Lm Srjrtfsy	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.06.2025

Trial locations

Investigated drugs:

Piperacillin/Tazobactam (PTZ) is an antibiotic combination medication used to treat serious bacterial infections. It works by stopping the growth of bacteria. This medication combines two different antibiotics that work together to fight infections, particularly those caused by resistant bacteria.

Meropenem is a powerful antibiotic belonging to the carbapenem class. It is used to treat severe bacterial infections and is particularly effective against a wide range of bacteria, including those that have become resistant to other antibiotics. It works by preventing bacteria from building their cell walls, which leads to their death.

Both medications are given intravenously (through a vein) and are commonly used to treat serious bloodstream infections caused by certain types of bacteria that have become resistant to other antibiotics.

Bacteremia – A condition where bacteria are present in the bloodstream, causing a blood infection. The bacteria multiply in the blood, spreading throughout the body via the circulatory system. This condition typically develops when bacteria from another infection site enter the bloodstream. Bacteremia can cause various symptoms including fever, chills, and rapid breathing. The condition may affect different body systems as the bacteria travel through the blood vessels.

Clostridium difficile infection – An infection that affects the large intestine, causing inflammation of the colon. The condition typically develops after the use of antibiotics, which can disrupt the normal balance of bacteria in the gut. The infection leads to symptoms such as diarrhea, abdominal pain, and fever. The bacteria produce toxins that damage the lining of the intestine.

Enterobacteriaceae infections – Infections caused by a family of bacteria that commonly reside in the intestines. These bacteria can cause various types of infections when they spread to other parts of the body. The infections may affect different organs and systems, particularly the urinary tract, respiratory system, or bloodstream. Common bacteria in this family include Escherichia coli (E. coli), Klebsiella, and Enterobacter species.

Trial ID:

2024-518583-13-00

Protocol code:

PETERPEN

Trial Phase:

Therapeutic confirmatory (Phase III)

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Comparing piperacillin-tazobactam and meropenem for treating bloodstream infections caused by cephalosporin-resistant bacteria in adult patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?