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Comparison of ampicillin plus gentamicin versus piperacillin/tazobactam for empirical treatment of hospitalized patients with community‑acquired infection

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

The trial examines serious infections that begin outside the hospital, such as Urosepsis, pyelonephritis, cystitis, urinary tract infection, pneumonia and sepsis. Patients are hospitalized and receive one of two antibiotic combinations given through an IV line: a mixture of ampicillin plus gentamicin, or a mixture of piperacillin together with tazobactam. The infections being treated are classified as community-acquired infection.

The purpose of the study is to determine whether the first antibiotic combination works as well as, or better than, the second combination while being safe for patients. After enrollment, participants are randomly assigned to receive one of the two treatment regimens, which are started soon after hospital admission and continued for several days as decided by the treating doctors. Patients remain in the hospital for monitoring and are followed for about a month after the start of treatment.

Researchers will record whether a patient dies from any cause within 30 days and will check for signs of sudden loss of kidney function, known as acute kidney injury, during the same period. Kidney injury is identified when the kidneys stop filtering waste as well as they should, which can be detected through routine blood tests.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After agreeing to join the study, basic information such as age, weight, and medical history is recorded.

    The purpose of the study and what will happen during the trial are explained in simple terms.

  2. Step 2

    Randomization to a treatment group

    The patient is assigned by chance to one of two groups: ampicillin plus gentamicin or piperacillin/tazobactam.

    The assignment is done without the patient choosing, to ensure fair comparison.

  3. Step 3

    Start of intravenous medication

    The assigned medicines are given through a vein (intravenous).

    If the patient is in the ampicillin plus gentamicin group, two drugs are given:

    - ampicillin 8 g (grams) intravenously,

    - gentamicin 5 mg per kilogram of body weight intravenously.

    If the patient is in the piperacillin/tazobactam group, a single drug is given:

    - piperacillin/tazobactam 18 g intravenously.

  4. Step 4

    Daily dosing during hospital stay

    The medication(s) are administered each day while the patient remains in the hospital.

    The exact timing and number of doses per day are decided by the treating doctor, following the study protocol.

  5. Step 5

    Clinical monitoring

    Health professionals regularly check the patient’s temperature, blood pressure, and signs of infection improvement.

    Blood tests are performed to watch for possible kidney problems, which are a key safety concern in the study.

  6. Step 6

    Completion of treatment

    Once the infection is controlled or the doctor decides the course is finished, the intravenous medication is stopped.

    The patient may be discharged from the hospital at this point.

  7. Step 7

    30‑day follow‑up

    The patient is observed for up to 30 days after randomization to see if they survive and to check for any kidney injury.

    Information collected during this period is used to evaluate the main results of the study.

Who can join the trial?

4 criteria

  • Adult (Age ≥ 18 years): You must be 18 years old or older.
  • Arrival in hospital < 24 hours: You need to have been admitted to the hospital within the first 24 hours after arriving.
  • Suspicion of acute community‑acquired infection: The doctor believes you have a sudden infection that started outside the hospital (for example, a lung infection or urinary infection).
  • Treatment plan with specific antibiotics: Your doctor must intend to give you either the combination of piperacillin/tazobactam or the combination of ampicillin and gentamicin, which are medicines used to treat infections.

Who cannot join the trial?

11 criteria

  • Allergic to any of the study medicines (ampicillin, gentamicin, piperacillin, or tazobactam) – meaning you have had reactions such as rash, swelling, or trouble breathing when taking these drugs.
  • Unable to give informed consent – you cannot understand or agree to join the study.
  • Already taken part in this trial before.
  • Pregnancy or breastfeeding, or a positive pregnancy test (human chorionic gonadotropin test) for women who could become pregnant.
  • Suspected septic shock – a severe infection causing very low blood pressure and organ problems.
  • Kidney function very low, with a glomerular filtration rate less than 30 ml/min due to chronic kidney disease or recent acute kidney injury.
  • Has myasthenia gravis – a condition that makes muscles become weak easily.
  • Received the chemotherapy drug cisplatin or another aminoglycoside antibiotic within the last 30 days.
  • Already received any dose of the study drugs during the current hospital stay.
  • Needs a specific antibiotic that is required for your infection and is not allowed in this study.
  • Enrolled in another interventional trial that does not permit co‑enrolment (being in two studies at the same time).
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Investigated drugs

  • Ampicillin

    is an antibiotic that belongs to the penicillin family. It is given through an IV line and works by killing a wide range of bacteria that can cause infections. In this study, ampicillin is part of the test treatment that is being evaluated for its ability to help patients with community‑acquired infections.

  • Gentamicin

    is an antibiotic from the aminoglycoside class. It is also given by IV and helps fight bacterial infections by stopping the bacteria from making essential proteins. In the trial, gentamicin is used together with ampicillin as the test therapy to see how well this combination works and how safe it is for patients.

  • Piperacillin/tazobactam

    is a combination medication that includes piperacillin, a broad‑spectrum penicillin‑type antibiotic, and tazobactam, a substance that blocks enzymes some bacteria use to resist antibiotics. It is administered intravenously and is designed to treat many different types of bacterial infections. In this trial, piperacillin/tazobactam serves as the comparator treatment against which the ampicillin‑gentamicin combination is measured.

What is already known about the treatment

  • Gentamicin

    Gentamicin is given by injection into a vein (intravenous) and is an approved antibiotic widely described in medical literature. It is mainly used to treat serious infections such as urinary tract infections, pyelonephritis, sepsis, and pneumonia. Gentamicin works by attaching to bacterial ribosomes and stopping protein production, which kills the bacteria; it belongs to the aminoglycoside class of antibiotics.

  • Piperacillin/tazobactam

    Piperacillin/tazobactam is administered as an intravenous infusion and is a well‑established antibiotic combination with extensive clinical use. It is used for a broad range of infections including community‑acquired urinary tract infections, pneumonia, and sepsis. Piperacillin breaks down bacterial cell walls, while tazobactam blocks an enzyme that would destroy piperacillin, and together they are classified as a penicillin with a β‑lactamase inhibitor.

  • Ampicillin

    Ampicillin is given by intravenous injection and is a long‑standing, approved penicillin‑type antibiotic found in many medical references. It is used to treat infections such as urinary tract infections, pyelonephritis, pneumonia, and sepsis. Ampicillin works by interfering with the construction of bacterial cell walls, leading to bacterial death, and it belongs to the penicillin class of antibiotics.

Investigated diseases

  • Urosepsis

    A urinary tract infection that spreads into the bloodstream, causing a systemic inflammatory response. The infection can move from the kidneys or bladder into the blood vessels and travel throughout the body. Symptoms may include fever, chills, rapid breathing, and a feeling of overall illness. As the bacteria circulate, they can affect multiple organ systems. Ongoing inflammation may lead to further spread of the infection if not resolved.

  • Infection of unknown origin

    An infection where the source cannot be identified despite clinical evaluation. Patients often present with fever, chills, and general discomfort. The illness can involve any organ system and may spread through the bloodstream. Because the entry point is unclear, the infection can progress silently. Ongoing monitoring is needed to detect any changes in the pattern of symptoms.

  • Pyelonephritis

    An infection of the kidney tissue and renal pelvis, usually ascending from the lower urinary tract. It typically causes flank pain, fever, and sometimes urinary symptoms. The infection can involve the kidney’s filtering structures and may spread to surrounding tissues. Repeated episodes can lead to scarring of kidney tissue. If the infection continues, it may affect kidney function.

  • Cystitis

    Inflammation of the bladder, most often caused by bacteria entering through the urethra. Common signs include urgency, frequency, and a burning sensation during urination. The condition can remain confined to the bladder or progress upward. If the infection spreads, it may reach the kidneys. Persistent inflammation can irritate the bladder lining.

  • Urinary tract infection

    An infection affecting any part of the urinary system, including the urethra, bladder, ureters, or kidneys. It usually begins in the lower tract and may cause burning during urination and increased frequency. The bacteria can travel upward toward the kidneys. When the infection spreads, it can involve kidney tissue. Ongoing infection can lead to discomfort throughout the urinary tract.

  • Pneumonia

    An infection of the lung tissue that fills the air sacs with fluid or pus. Symptoms often include cough, fever, and difficulty breathing. The infection can involve one part of a lung or spread to multiple lobes. Inflammation may reduce the ability of the lungs to exchange oxygen. Continued infection can affect larger areas of the respiratory system.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-526131-20-00Estimated enrolment2 162 patientsSponsorRegion Hovedstaden

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