Table of Contents

• Clinical trials overview
• Trials in children
• Trials in adults
• Trials around surgery and prevention
• What the trials measure
• Study designs and phases
• Who may be included

Clinical trials overview

The trial data show that Amoxicillin is being studied in many different infection-related conditions, and in some studies it is combined with clavulanic acid or compared with other antibiotics or placebo.^[1][2] Most of the studies are Phase 3 trials, which usually means they compare treatments in larger groups and focus on how well a treatment works in real patients.^[1]

The studies include children, adults, older adults, pregnant women, and some special patient groups such as people with brain tumors or people on hemodialysis.^[1][2] Several trials are designed to find out whether a shorter treatment is enough, whether Amoxicillin is not worse than another treatment, or whether it can help reduce infection-related problems after procedures.^[1][2]

Trials in children

Many of the Amoxicillin studies focus on children, especially for common infections such as acute otitis media (middle ear infection) and urinary tract infections.^[1] In the acute otitis media trial, researchers compare Amoxicillin with Amoxicillin-clavulanate and placebo to see which option works best for children, and the main outcome is daily symptom scoring during the first 14 days.^[1]

Another pediatric study looks at a personalized antibiotic plan for febrile urinary tract infections and asks whether a shorter Amoxicillin-clavulanic acid course after fever ends is not worse than the standard 10-day regimen.^[1] The main endpoint is infection recurrence, which means the infection comes back within 30 days after treatment ends.^[1]

Children are also included in studies of appendicitis, osteomyelitis (bone infection), protracted cough, and serious bacterial infections.^[1] In these trials, the researchers often compare antibiotic treatment with surgery, placebo, or other antibiotic plans, and they measure recovery, relapse, treatment failure, and adverse events.^[1]

Trials in adults

Adult studies include community-acquired pneumonia, infective endocarditis, vertebral osteomyelitis, sepsis, diverticulitis, and urinary infections caused by resistant bacteria.^[1] In older adults with pneumonia, one trial compares Amoxicillin alone with Amoxicillin-clavulanate and measures clinical success at day 30, meaning survival, improvement of infection symptoms, and no need for more antibiotic treatment.^[1]

In infective endocarditis, Amoxicillin appears in trials that study oral antibiotic treatment and oral step-down therapy, which means switching from an initial stronger route such as intravenous treatment to tablets later in the course.^[1] These studies look at outcomes such as death, unplanned surgery, recurrent bacteremia, and relapse within months after treatment.^[1]

Other adult studies include chronic low back pain with Modic type I changes on MRI, where Amoxicillin is compared with placebo and the main measure is pain and disability on the Roland Morris Disability Questionnaire.^[1] This is a non-infection study in the trial list, but it still investigates Amoxicillin as the study drug.^[1]

Trials around surgery and prevention

Some trials test whether Amoxicillin can help prevent infection after surgery or other procedures.^[1] Examples include oral implant surgery with guided bone regeneration and sinus floor elevation, bone augmentation procedures, cystectomy, and obstetric perineal tear care.^[1]

These studies often measure outcomes such as wound infection, wound opening, pain, swelling, bleeding, hospital readmission, and patient-reported discomfort.^[1] In one dental study, the main outcomes are patient-reported symptoms like wound pain, swelling, bruising, bleeding, nosebleed, blocked nose, runny nose, pressure, and reduced smell.^[1]

One sepsis trial compares different intravenous antibiotic strategies, including Amoxicillin-containing treatment, and measures 28-day mortality.^[1] Another study in patients on hemodialysis tests whether antibiotic prophylaxis with Amoxicillin-clavulanic acid can reduce blood stream infection and severe infection within 6 months.^[1]

What the trials measure

The trial endpoints are the main results that researchers want to measure, and they differ by condition.^[1] Common endpoints include symptom improvement, cure, treatment failure, relapse, recurrence, hospital readmission, and death.^[1]

Some studies use patient or parent scores, such as cough scores or ear infection symptom scores, because these show how the patient feels day by day.^[1] Other studies use clinical outcomes such as culture-proven infection, surgery after failed treatment, or imaging and lab results when needed.^[1]

Several trials also include safety measures, such as adverse events, serious adverse events, and treatment-related complications.^[1] In some studies, researchers also look at cost-efficiency or patient satisfaction, showing that the trials are not only about cure but also about the overall treatment experience.^[1]

Study designs and phases

The studies are mostly interventional, which means the researchers assign a treatment and then observe what happens.^[1] Many are randomized trials, and some are double-blinded or open-label, depending on whether patients and researchers know which treatment is given.^[1]

Most trials in the list are Phase 3, but there are also Phase 2 and Phase 1 studies, plus low-intervention studies.^[1] Phase 1 studies in the list focus on measuring drug levels in the body, such as antibiotic concentrations in cerebrospinal fluid and plasma in children with brain tumors.^[1]

Phase 2 studies in the list include smaller studies on bone infection, urinary infection prevention, and other early questions about safety and effectiveness.^[1] The larger Phase 3 studies usually compare Amoxicillin-based treatment with placebo, surgery, or another antibiotic plan to see if one approach is at least as good as another.^[1]

Who may be included

Eligibility depends on the condition and the study question.^[1] Some trials include young children with cough or ear infection, while others include older children with appendicitis or bone infection, adults with pneumonia or endocarditis, or special groups such as pregnant women and people with spinal cord injury or multiple sclerosis.^[1]

Several studies also focus on people with a very specific clinical situation, such as uncomplicated appendicitis, resistant urinary tract infection, or infection after implant surgery.^[1] This means a person can only join a trial if they match the study’s own rules for age, diagnosis, and treatment setting.^[1]