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Study of Piperacillin and Tazobactam Given Under the Skin Compared to a Vein in Patients with Infectious Diseases

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at people with infectious disease who need treatment with antibiotics. The treatment being used is a combination of two medicines called piperacillin and tazobactam. These medicines are normally given through a vein, which means a needle is placed into a vein and the medicine drips slowly into the bloodstream. This study wants to test if giving these medicines under the skin, which means injecting them into the tissue just beneath the skin surface, works just as well as giving them through a vein. The study will include people who have serious infections such as severe lung infection, fever in patients with low white blood cell counts that may be caused by bacteria, or other serious bacterial infections.

The purpose of the study is to compare how the body processes these medicines when they are given under the skin compared to when they are given through a vein. During the study, patients will receive either the medicine under the skin or through a vein. Blood samples will be collected to measure the amount of medicine in the blood over time. This helps researchers understand if the medicine reaches the same levels in the body with both methods of giving it. The treatment period will last for up to ten days, and doctors will check how well the infection is responding to the treatment.

The study will also look at whether the medicine levels in the blood stay high enough to fight the infection effectively. Doctors will measure if the signs and symptoms of infection improve or go away without needing additional antibiotics. They will also check if the bacteria causing the infection are eliminated. Any side effects or unwanted reactions that occur during treatment and up to one day after treatment ends will be recorded. This information will help determine if giving these antibiotics under the skin is a safe and effective alternative to giving them through a vein.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Random assignment to treatment group
Upon joining the study, you will be randomly assigned to one of two groups. This process is similar to flipping a coin and determines how you will receive the antibiotic medication.
One group will receive the medication through a vein (intravenous route), which is the standard method. The other group will receive the medication through an injection under the skin (subcutaneous route).
The medication used is called piperacillin/tazobactam, which is an antibiotic combination used to treat serious bacterial infections.
Step 2
Treatment period with antibiotic administration
You will receive piperacillin/tazobactam at a dose of 18 grams per day through continuous infusion. This means the medication will be given slowly and steadily over an extended period.
The method of administration depends on your assigned group: either through a vein or under the skin.
The treatment will continue for the duration determined necessary for your infection, based on your doctor's clinical judgment.
The medication is specifically indicated for conditions such as severe pneumonia, fever in patients with low white blood cell counts suspected to be caused by bacterial infection, or other serious bacterial infections.
Step 3
Blood sample collection for medication level monitoring
During the treatment period, blood samples will be collected from you at specific times to measure the concentration of the antibiotic in your blood.
These measurements help determine how your body processes the medication and whether adequate levels are maintained in your bloodstream.
The target concentration of piperacillin in your blood should be at or above 40 milligrams per liter to ensure the medication is effective against the infection.
Step 4
Clinical and microbiological assessment
Your clinical condition will be monitored throughout the treatment to assess whether your infection symptoms are improving.
Clinical cure is defined as partial or complete resolution of your infection signs and symptoms without needing additional antibiotic treatment.
If applicable, microbiological tests may be performed to determine whether the bacteria causing your infection have been successfully eliminated.
Step 5
End of treatment evaluation
At the end of your treatment period (approximately day 9), a final assessment will be conducted.
If you are a woman of childbearing potential, a urine pregnancy test will be performed at this visit.
Your overall response to treatment will be evaluated, including the resolution of infection symptoms and any side effects experienced.
Step 6
Safety monitoring for adverse events
Throughout the study and up to 1 day after the end of treatment, any side effects or adverse events you experience will be recorded and monitored.
You should report any unusual symptoms or reactions to the medical staff during this period.

Who can join the trial?

8 criteria

You must provide free, written and informed consent by signing the consent form
You must be at least 18 years old on the day you join the study
Both men and women can participate
You must have a medical need for treatment with piperacillin/tazobactam, which is an antibiotic medication given continuously through a vein at a dose of 18 grams per day. This includes conditions such as severe lung infection, fever with low white blood cells suspected to be caused by bacteria, or other serious bacterial infections where your doctor believes this treatment is right for you
If you are a woman who has gone through menopause, which means you have not had a period for at least 12 months in a row without another medical reason, and if needed, this is confirmed by a blood test measuring FSH, a hormone that indicates menopause
If you are a woman who can become pregnant and are sexually active with a man who has not had a vasectomy, you must have a negative pregnancy blood test at the beginning of the study and a negative urine pregnancy test at the end of treatment on day 9
Women who can become pregnant are those who have not had surgery to prevent pregnancy, such as removal of both fallopian tubes, removal of both ovaries, or removal of the uterus, and who have not gone through menopause
You must be admitted to one of the hospital wards that is approved to enroll patients in this study

Who cannot join the trial?

1 criterion

No specific exclusion criteria (reasons why patients cannot participate) have been provided for this clinical trial at this time

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Verified sites

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Azienda Sanitaria Universitaria Friuli Centrale
Verified
Udine, Italy
Universita' Degli Studi Di Verona
Responsive
Verona, Italy

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Investigated drugs

Piperacillin/Tazobactam is an antibiotic medication that is used to treat bacterial infections. In this trial, it will be given in two different ways: through an injection under the skin (subcutaneous) or through a vein (intravenous). The study will compare how the body processes the medication when given by these two different methods.

What is already known about the treatment

Piperacillin/Tazobactam – This is an antibiotic combination medication that is being studied in a new way of administration through injection under the skin (subcutaneous), compared to the traditional method of giving it directly into a vein (intravenous). The medication is currently used in hospitals to treat serious bacterial infections and works by combining two substances: piperacillin, which kills bacteria by breaking down their cell walls, and tazobactam, which helps piperacillin work better by blocking enzymes that bacteria use to protect themselves. This combination belongs to a class of antibiotics called beta-lactam antibiotics with beta-lactamase inhibitors, and this clinical trial is testing whether giving it under the skin provides similar levels of the drug in the bloodstream as the standard intravenous method.

Investigated diseases

Infectious Disease – Infectious disease is a condition caused by harmful microorganisms such as bacteria, viruses, fungi, or parasites that enter the body. These microorganisms can spread from person to person, through contaminated food or water, or from animals to humans. When the body becomes infected, the immune system tries to fight off the invading organisms. Symptoms vary widely depending on the type of infection but commonly include fever, fatigue, body aches, and inflammation at the site of infection. The infection can affect different parts of the body including the lungs, blood, skin, or urinary tract. The disease progresses as the microorganisms multiply and spread through the body, causing tissue damage and triggering immune responses.