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A study testing prednisone combined with antibiotics compared to antibiotics alone in adults with septic arthritis to improve joint health

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 looks at septic arthritis, which is a joint infection caused by bacteria or other germs. When someone has this condition, the joint becomes inflamed, painful, and filled with fluid that may contain the infectious organism. The study will test whether adding a medication called prednisone, which is a type of corticosteroid that reduces inflammation and swelling in the body, to the usual antibiotic treatment can improve how well the joint works after the infection. Corticosteroids work by calming down the body's immune response, which may help protect the joint from damage caused by inflammation. Some people in the study will receive prednisone while others will receive placebo alongside their antibiotic treatment.

The purpose of this study is to evaluate whether corticosteroid administration alongside antibiotic therapy modifies joint prognosis in adult septic arthritis at 24 weeks. During the study, participants will take either prednisone or placebo for seven days while continuing their antibiotic treatment. The maximum daily dose of prednisone will be 60 milligrams, and the total amount taken over the treatment period will not exceed 420 milligrams. The study will follow participants for 24 weeks to see how well their affected joint is functioning.

Throughout the study, doctors will measure several things to understand if the treatment is working. They will check how well the joint moves by measuring its ability to bend and straighten, assess pain levels, take images of the joint to look for any problems, and track how many surgeries are needed. They will also measure markers of inflammation in the blood, ask participants to rate their own recovery, and evaluate quality of life. The study will monitor for any unwanted effects of the treatment, particularly effects on blood sugar levels and mental health symptoms. Participants will be assessed at different time points including at one week, six weeks, and 24 weeks after starting the study treatment.

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

    Treatment initiation

    After joining the study, you will be randomly assigned to receive either prednisone (a corticosteroid medication) or placebo (an inactive substance that looks like the medication but contains no active ingredient).

    You will receive prednisone 20 mg tablets or matching placebo tablets to take by mouth.

    This treatment will be given in addition to the antibiotic therapy you are already receiving for your joint infection.

    Neither you nor your doctor will know which treatment you are receiving during the study.

  2. Step 2

    Week 1 assessment

    At week 1, your joint movement will be measured using a device called a goniometer, which measures how far your joint can bend and straighten.

    Your pain level will be assessed using a Visual Analog Scale, where you will rate your pain on a line from no pain to worst possible pain.

    Blood tests will be taken to measure inflammatory markers, which are substances in your blood that indicate inflammation in your body.

    You will be asked to rate your own recovery on a scale from 0 to 5, where 0 means no improvement and 5 means full recovery.

    Any side effects or adverse reactions will be monitored, particularly blood sugar levels and any effects on mood or mental state.

  3. Step 3

    Week 6 assessment

    At week 6, your joint movement will again be measured using the goniometer.

    Your pain level will be assessed using the Visual Analog Scale.

    Blood tests will be taken to measure inflammatory markers.

    You will rate your own recovery on the 0 to 5 scale.

    The number of days you have taken pain medication between week 1 and week 6 will be recorded, including the type of pain medication used.

    Any side effects or adverse reactions will continue to be monitored.

  4. Step 4

    Week 24 final assessment

    At week 24, your joint function will be assessed using a standardized questionnaire. If your affected joint is in the lower body (hip, knee, or ankle), the WOMAC score will be used. If your affected joint is in the upper body (shoulder, elbow, or wrist), the QuickDASH score will be used. Both questionnaires measure pain, stiffness, and physical function, with results reported on a scale from 0 to 100 points.

    Your joint movement will be measured using the goniometer. If your hip or knee was affected, your doctor will check whether you have a flexion contracture, which means your joint cannot fully straighten.

    An imaging examination of your joint will be performed to check for any complications.

    Your pain level will be assessed using the Visual Analog Scale.

    Blood tests will be taken to measure inflammatory markers.

    You will rate your own recovery on the 0 to 5 scale.

    Your quality of life will be assessed using the EQ-5D-5L questionnaire, which asks about mobility, self-care, usual activities, pain, and anxiety or depression.

    Any side effects or adverse reactions will continue to be monitored.

  5. Step 5

    Additional information recorded throughout the study

    The total duration of your antibiotic treatment will be recorded.

    The length of your hospital stay will be recorded.

    Any surgical procedures performed on your joint between the start of the study and week 24 will be recorded.

    All side effects and adverse events will be monitored throughout the study, with particular attention to blood sugar control and any effects on mood or mental state.

Who can join the trial?

6 criteria

  • You must be 18 years of age or older
  • You must have a confirmed septic arthritis, which is an infection in your joint. This infection must be proven by one of the following: a germ found in your joint fluid through laboratory testing, cloudy joint fluid with bacteria seen under a microscope, or bacteria found in your blood
  • You must have started taking antibiotic treatment (medicine that fights bacterial infections) that works against your infection within 3 days or less
  • You must sign a document agreeing to participate in the study after receiving information about it
  • You must have health insurance coverage
  • You must be able to read, write, and understand French

Who cannot join the trial?

9 criteria

  • Pregnant women - women who are expecting a baby cannot take part in this study
  • Breastfeeding women - women who are nursing a baby cannot participate
  • People who have had a joint replacement in the affected joint - if you have an artificial joint where the infection is located, you cannot join
  • People with prosthetic material in the infected joint - if you have any artificial parts or metal implants in the joint with infection, you are not eligible
  • People who have been taking corticosteroids regularly - if you are already using steroid medications on a long-term basis, you cannot participate. Corticosteroids are medications that reduce inflammation in the body
  • People with uncontrolled diabetes - if your blood sugar levels are not well managed, you cannot take part
  • People with conditions that weaken the immune system - if you have a disease or are taking medications that make it harder for your body to fight infections, you are not eligible. The immune system is your body's natural defense against germs and illness
  • People with known allergy to corticosteroids - if you have had allergic reactions to steroid medications in the past, you cannot join
  • People unable to give informed consent - if you cannot understand and agree to participate in the study on your own, you are not eligible
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Investigated drugs

  • Corticosteroids

    are medications that reduce inflammation and swelling in the body. In this trial, they are being tested to see if they can help improve joint health when given together with antibiotics to treat septic arthritis, which is a serious infection in the joints.

  • Antibiotics

    are medications that fight bacterial infections. In this trial, they are used as the standard treatment for septic arthritis, and researchers want to see if adding corticosteroids to the antibiotic treatment can lead to better outcomes for the joints.

What is already known about the treatment

Corticosteroids – Corticosteroids are anti-inflammatory medications that can be given in various forms including pills, injections, or intravenous infusions, depending on the condition being treated. These drugs work by mimicking natural hormones produced by the adrenal glands and suppress the immune system's inflammatory response by blocking the production of substances that cause inflammation and swelling in the body. They are widely used in medicine to treat many conditions involving inflammation, such as arthritis, allergic reactions, asthma, and autoimmune diseases. In this clinical trial, corticosteroids are being studied alongside antibiotics to see if they can improve joint outcomes in patients with septic arthritis, which is a serious infection of the joints.

Investigated diseases

Septic Arthritis – Septic arthritis is an infection of a joint caused by bacteria that enter the joint space. The infection leads to inflammation within the joint, causing swelling, warmth, redness, and severe pain in the affected area. As the condition progresses, the bacterial infection can damage the cartilage and bone within the joint. The body's immune response to the infection produces pus and fluid that accumulate in the joint space. Without proper management, the infection can spread to surrounding tissues and potentially enter the bloodstream. The condition most commonly affects large joints such as the knee, hip, shoulder, elbow, wrist, and ankle.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-522193-37-00Protocol codeAPHP240792Estimated enrolment200 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

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