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A study comparing azithromycin with cefuroxime versus cefuroxime alone for preventing infections in patients undergoing hysterectomy

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What is this trial about?

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

This study focuses on preventing infections in patients undergoing hysterectomy, which is a surgical procedure to remove the uterus. The research aims to compare two different approaches to infection prevention: using a combination of two antibiotics (azithromycin and cefuroxime) versus using cefuroxime alone with placebo.

The study examines the effectiveness of different antibiotic combinations in preventing various types of infections that can occur after surgery. These infections may include complications in the surgical wound, pelvic area, urinary tract, and conditions involving fever. The research focuses specifically on infections that can develop within 30 days after the surgical procedure.

During the study, participants will receive either a combination of antibiotics or a single antibiotic with placebo. The medications will be given orally. The treatment period is short, consisting of a single day of medication administration. The study will monitor patients for any signs of infection or complications following their surgery.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication before surgery

    You will receive either a combination of azithromycin and cefuroxime, or cefuroxime with a placebo tablet

    The medication will be given orally (by mouth) before the hysterectomy (surgical removal of the uterus)

  2. Step 2

    Surgery procedure

    The hysterectomy will be performed according to standard medical procedures

    The surgery will be conducted for non-cancerous (benign) conditions

  3. Step 3

    Post-surgery monitoring - first 2 days

    Your temperature will be monitored for fever (above 38°C/100.4°F)

    Medical staff will check your surgical wound for any signs of infection

    Your recovery will be monitored for any urinary tract infections

  4. Step 4

    30-day follow-up period

    Your surgical site will be monitored for both surface and deep wound infections

    Any infections in the pelvic area will be documented

    The monitoring period will continue for 30 days after your surgery

  5. Step 5

    Study completion

    The follow-up period ends after 30 days post-surgery

    Your participation in the study will be complete after this monitoring period

Who can join the trial?

8 criteria

  • Must be a female patient
  • Must be an adult (18 years or older)
  • Must be scheduled to undergo a hysterectomy (surgical removal of the uterus) for non-cancerous conditions
  • Must not have any known allergies or other medical conditions that would prevent the use of azithromycin (an antibiotic medication) or cefuroxime (another type of antibiotic)
  • Must be having the surgery performed at a public hospital in Finland
  • Must be able to understand information provided in Finnish or Swedish languages
  • Must not be pregnant or breastfeeding
  • Must not belong to any vulnerable population groups

Who cannot join the trial?

12 criteria

  • Age below 18 years or above 65 years
  • Male patients (study is for females only)
  • Known allergy or hypersensitivity to azithromycin or cefuroxime (the antibiotics used in the study)
  • Currently having an active infection requiring antibiotic treatment
  • Pregnant or breastfeeding women
  • Having other surgical procedures planned alongside hysterectomy
  • Having taken antibiotics within 7 days before the planned surgery
  • Having a known immune system disorder (conditions that affect body's ability to fight infections)
  • History of severe reactions to antibiotics
  • Having serious liver or kidney problems
  • Participation in another clinical trial within the last 30 days
  • Unable to provide informed consent
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Investigated drugs

  • Azithromycin

    is an antibiotic medication that helps prevent and treat bacterial infections. It belongs to a group of antibiotics called macrolides and works by stopping the growth of bacteria. In this trial, it is used as a preventive measure against infections that may occur after hysterectomy surgery.

  • Cefuroxime

    is an antibiotic that fights bacteria in the body. It belongs to a group of medications called cephalosporin antibiotics. It works by preventing bacteria from building their cell walls, which helps stop infections. In this trial, it is used alone or in combination with azithromycin to prevent post-surgical infections following hysterectomy.

What is already known about the treatment

  • Azithromycin

    An oral or intravenous antibiotic belonging to the macrolide class of medications, widely used in clinical practice for infection prevention and treatment. This medication works by binding to bacterial ribosomes and preventing protein synthesis, effectively stopping bacterial growth and reproduction. It is particularly effective against a broad spectrum of bacteria and is commonly used in surgical prophylaxis, especially in combination with other antibiotics for preventing post-operative infections.

  • Cefuroxime

    A second-generation cephalosporin antibiotic that can be administered orally or intravenously, commonly used for surgical prophylaxis and treatment of various bacterial infections. It works by interfering with bacterial cell wall synthesis, leading to cell death, and is particularly effective against many common pathogens involved in post-surgical infections. This medication has a well-established safety profile and is frequently used in pre-operative protocols to prevent post-surgical complications.

Investigated diseases

  • Post-operative Surgical Site Infection

    An infection that develops in the area of the surgical incision after a hysterectomy procedure. It can affect either the superficial layers of the skin or extend deeper into the surgical site. The infection typically develops within 30 days after surgery and may be accompanied by redness, swelling, and warmth around the incision site.

  • Pelvic Organ Infection

    An infection that occurs in the pelvic region following gynecological surgery. It can affect various organs in the pelvic area and may develop gradually over several days or weeks after the operation. The condition can involve inflammation of the surrounding tissues in the pelvic cavity.

  • Urinary Tract Infection

    An infection affecting any part of the urinary system, most commonly involving the bladder and urethra. The infection occurs when bacteria enter the urinary tract, causing inflammation and discomfort. Symptoms typically include frequent urination, burning sensation during urination, and cloudy urine.

  • Post-operative Fever

    A sustained elevation in body temperature above 38°C (100.4°F) that persists for more than two days following surgery. This condition represents the body's response to the surgical procedure or potential post-operative complications. The fever may be accompanied by general discomfort and increased heart rate.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517508-12-00Estimated enrolment2 278 patientsSponsorHUS-yhtymae

sourced from the EU Clinical Trials Register and site verification

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