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Shortened postoperative antibiotic course (3 vs 5 days) in children with acute perforated appendicitis using piperacillin/tazobactam drug combination

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 condition being studied is Pediatric Acute Perforated Appendicitis, a sudden infection where the appendix bursts and requires emergency removal. After the operation, doctors give medicines called antibiotics to stop any remaining bacteria from causing new infections. In this trial the antibiotics used may include metronidazole, piperacillin/tazobactam, amoxicillin/clavulanic acid, cefotaxime, ciprofloxacin and clindamycin, given by mouth or through a vein.

The aim of the study is to find out whether a shorter course of three days of these medicines is not worse than the usual five days in keeping children safe after surgery. Children who have had the appendix removed are randomly placed into one of two groups: one group receives antibiotics for three days, the other for five days. All participants stay in the hospital for the usual recovery period and are then checked for about a month to see if any problems develop.

“Postoperative” means after the surgery has been completed. An intra-abdominal abscess is a pocket of infected fluid that can form inside the belly, while a wound infection is an infection of the skin cut made for the operation. Doctors will look for signs of these problems, as well as measure a blood test called CRP that goes up when there is inflammation in the body. Any need for extra treatment, such as another operation or a scan, will be recorded during the follow‑up period.

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

    Randomization to Antibiotic Duration

    After joining the study, you will be randomly assigned to receive postoperative antibiotics for either 3 days or 5 days. This assignment is made by the study team without your input.

    The purpose of randomization is to compare the safety of a shorter antibiotic course with the standard longer course.

  2. Step 2

    Start of Postoperative Antibiotic Treatment

    On the day of surgery, you will begin receiving one of the study antibiotics. The possible medicines and their standard doses are:

    Metronidazole: 1200 mg taken orally as a film‑coated tablet.

    Piperacillin/tazobactam: 12 g (12 g piperacillin combined with 0.25 g tazobactam) given intravenously as a solution for infusion.

    Amoxicillin/clavulanic acid: 1500 mg (amoxicillin 1250 mg plus clavulanic acid 250 mg) taken orally as a suspension.

    Cefotaxime: 6 g given intravenously as a solution for injection/infusion.

    Ciprofloxacin: 1200 mg given intravenously as a solution for infusion.

    Clindamycin: 1800 mg taken orally as a granulate dissolved in water.

    The specific antibiotic you receive will be chosen by the treating physician based on clinical judgement.

  3. Step 3

    Daily Administration of Antibiotics

    You will receive the assigned antibiotic once each day for the number of days determined by your randomization group (either 3 or 5 days).

    Oral medicines are taken with water, and intravenous medicines are administered through a vein by a nurse.

    Each dose follows the amount listed in the previous step.

  4. Step 4

    Monitoring for Side Effects and Infection Signs

    During the antibiotic period, hospital staff will check your temperature, heart rate, and wound appearance each day.

    You will be asked about any new symptoms such as nausea, diarrhea, rash, or pain.

    If a side effect occurs, the medical team may adjust the medication or provide additional treatment.

  5. Step 5

    Completion of Antibiotic Course

    At the end of the assigned 3‑day or 5‑day period, you will stop taking the study antibiotic.

    The staff will record that the course is finished and note any reasons for early discontinuation if they occur.

  6. Step 6

    Hospital Discharge and Length‑of‑Stay Recording

    When you are medically ready, you will be discharged from the hospital.

    The total number of days you stayed in the hospital after surgery will be recorded as part of the study.

  7. Step 7

    30‑Day Follow‑Up Assessment

    Approximately 30 days after your surgery, you will have a follow‑up visit (in person or by telephone) to assess recovery.

    The clinician will ask about any infections, wound problems, or other complications that may have occurred.

    If needed, imaging studies such as an ultrasound or X‑ray may be performed to look for hidden abscesses.

    All findings, including any re‑operations, readmissions, or additional antibiotic use, will be documented.

Who can join the trial?

3 criteria

  • Be younger than 16 years old.
  • Have had an operation for acute perforated appendicitis (a sudden infection of the appendix that has burst, causing pus or stool to leak into the belly) at one of the participating hospitals.
  • Receive both written and spoken information about the study and obtain permission from your parents or legal guardians, plus agreement from you (the child) to take part.

Who cannot join the trial?

8 criteria

  • Having a very serious other illness that makes you an ASA 4–5 (a high risk level for surgery).
  • Having a known condition called inflammatory bowel disease (long‑term inflammation of the intestine).
  • Having had previous surgery for a birth‑related gut problem, known as a congenital intestinal anomaly.
  • Having moderate to severe intellectual disability that makes it difficult to give a reliable medical history.
  • Being pregnant.
  • Currently taking antibiotics for a different infection.
  • Having a weakened immune system, called immunosuppression, which reduces your body’s ability to fight infections.
  • Having any listed contraindications (reasons not to use a drug) in the medication’s official product information (SmPC) that prevent changing the antibiotic.
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Investigated drugs

  • Metronidazole

    is an antibiotic taken by mouth that works well against certain bacteria and parasites. In this study it is given after the appendix surgery to help prevent infections inside the abdomen and at the wound site.

  • Piperacillin/Tazobactam

    is a combination of two medicines given through an IV line. It attacks a wide range of bacteria that could cause infection after the operation. The trial uses it to see if a short three‑day course works as well as a longer five‑day course.

  • Amoxicillin and clavulanic acid

    is a mixed antibiotic taken by mouth as a liquid suspension. Amoxicillin kills many common bacteria, and clavulanic acid helps it work better against bacteria that might resist treatment. It is used after surgery to protect against postoperative infections.

  • Cefotaxime

    is an IV antibiotic that belongs to the cephalosporin group. It is strong against many types of bacteria that could cause infection after the appendix is removed. The study gives it to compare short versus longer treatment periods.

  • Ciprofloxacin

    is an antibiotic given through an IV infusion. It is especially good at fighting bacteria that can cause serious infections inside the body. In the trial it is part of the postoperative antibiotic regimen being tested.

  • Clindamycin

    is an oral antibiotic that comes as a liquid that can be mixed for drinking. It works against a variety of bacteria, including those that might cause wound infections after surgery. The study includes it to see if a three‑day course is enough to keep patients safe.

What is already known about the treatment

  • Metronidazole

    This medication is supplied as film‑coated tablets taken by mouth. It is an established drug that is widely used and well described in medical literature. Metronidazole is mainly prescribed for infections caused by anaerobic bacteria and certain parasites, such as those that can occur after a perforated appendix. It works by entering bacterial cells and damaging their DNA, and it belongs to the nitroimidazole class of antibiotics.

  • Piperacillin/Tazobactam

    The drug comes as a powder that is mixed and given as an intravenous infusion. It is a standard, approved combination that is commonly used for serious hospital‑acquired infections. This medication treats a broad range of bacterial infections, especially intra‑abdominal and postoperative infections. Piperacillin blocks the building of the bacterial cell wall, while tazobactam protects it from enzymes that would otherwise destroy the antibiotic; together they form a penicillin‑beta‑lactamase inhibitor combination.

  • Amoxicillin/Clavulanic acid

    Provided as an oral suspension that is mixed and swallowed. It is a widely accepted and frequently prescribed antibiotic mixture. The combination is used for mixed bacterial infections, including those that can follow abdominal surgery. Amoxicillin stops the bacteria from making a proper cell wall, and clavulanic acid blocks the enzymes that many bacteria produce to resist amoxicillin; the pair belongs to the penicillin‑beta‑lactamase inhibitor class.

  • Cefotaxime

    Supplied as a powder that is reconstituted for intravenous injection or infusion. It is an approved third‑generation cephalosporin that is routinely used in hospitals. Cefotaxime treats serious bacterial infections such as those that may arise after abdominal surgery. The drug works by preventing the bacteria from forming a strong cell wall, and it is classified as a cephalosporin antibiotic.

  • Ciprofloxacin

    This medication is a solution given by intravenous infusion. It is a well‑known, approved fluoroquinolone used for a variety of serious infections. Ciprofloxacin is often chosen for Gram‑negative bacterial infections that can occur after surgery. It acts by blocking enzymes needed for bacterial DNA replication, and it belongs to the fluoroquinolone class of antibiotics.

  • Clindamycin

    Available as a granulate that is mixed into an oral solution and taken by mouth. It is an established drug with a long history of use in clinical practice. Clindamycin is used for infections caused by anaerobic bacteria, which are common in abdominal infections. The medicine stops bacteria from making proteins they need to grow, and it is classified as a lincosamide antibiotic.

Investigated diseases

Acute perforated appendicitis (paediatric) - This is an inflammation of the appendix in children that has ruptured, allowing infected material to spill into the abdominal cavity. The condition typically begins with abdominal pain and fever, then progresses to peritonitis as the infection spreads. If the perforation is not quickly treated, pus can collect and form intra‑abdominal abscesses. The inflammatory response can extend to surrounding tissues, causing swelling and possible intestinal blockage. The disease may further evolve into systemic infection if bacteria enter the bloodstream.
Trial detailsLast updated 5 Nov 2026
Age0-17PhasePhase IIITrial ID2026-525977-38-00Protocol codePAPAEstimated enrolment470 patientsSponsorVaestra Goetalandsregionen

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