Interest of Intra-nodal injection of gentamicin for the treatment of suppurated cat scratch disease's lymphadenitis: a randomized controlled study. "BIGG" : Bartonellosis and intra-nodal injection of gentamicin
This study, called "BIGG," aims to find a better way to treat swollen glands caused by cat scratch disease. This infection, caused by a bacterium often spread by cats, can lead to painful, swollen lymph nodes (glands). Researchers are comparing a direct injection of an antibiotic called gentamicin into the affected gland with standard treatments, which include another antibiotic called azithromycin, or a salt solution. The main goal is to see if direct injection can significantly reduce the size of the swollen gland by at least 80% and avoid the need for further medical procedures like draining or surgery. The study also checks how well the treatment reduces pain and if it's safe.
At a glance
What is this study about?
Imagine you have a painful, swollen gland, perhaps in your armpit or neck, after being scratched by a cat. This is often caused by an infection we call cat scratch disease, or CSD. Doctors often treat this with antibiotics, but sometimes the swelling can be really stubborn, needing multiple visits to the clinic or even a small operation.
This study is looking into a new approach: injecting an antibiotic called gentamicin directly into the swollen gland. The idea is that delivering the medicine straight to where the infection is could be more effective at shrinking the swelling and easing the pain. This is being compared to more common treatments, like taking a different antibiotic by mouth (azithromycin) or simply injecting a saline (saltwater) solution, which acts as a comparison to see if the gentamicin injection is truly helping.
The main goal of the study is to see if this direct injection can reduce the size of your swollen gland by at least 80% within 28 days. They also want to see if it can help you avoid needing extra procedures like having fluid drained with a needle or requiring surgery on the gland. The researchers also want to make sure the treatment is safe and doesn't cause too many side effects.
Key takeaways
- This study is testing a new way to treat swollen glands from cat scratch disease.
- It compares injecting an antibiotic directly into the gland versus standard treatments.
- The main aim is to reduce gland size by 80% and avoid extra medical procedures.
- Participation involves about a month of visits for checks and treatment.
- You could receive an active drug, a different oral antibiotic, or a salt water injection.
- All adults (18+) with cat scratch disease causing a swollen gland might be eligible.
Who may be eligible?
To join this study, you generally need to be an adult, 18 years or older, and can be male or female. You must have been diagnosed with cat scratch disease that has caused swollen and painful glands, and these glands must be showing signs of infection, such as pus.
There are also some specific medical conditions that might mean you can't take part. For example, if you're pregnant or breastfeeding, have certain allergies to the medicines being studied, or have other serious health problems that might make the treatment unsafe for you.
The research team will carefully review your medical history and current health to make sure that taking part is suitable and safe for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Have you been diagnosed with cat scratch disease that has caused a swollen gland?
- Are you generally in good health apart from the cat scratch disease?
- Are you able to attend regular appointments for about a month?
- Are you not pregnant or breastfeeding?
What does participation involve?
If you decide to take part in this study, you would first have a detailed check-up to see if you're suitable. If you are, you would be randomly assigned to one of three groups: one group would receive an injection of gentamicin into your swollen gland, another would receive a different antibiotic (azithromycin) by mouth, and a third group would receive an injection of sterile salt water, which helps scientists compare the results.
You would have several visits over about a month. On these visits, doctors would use ultrasound scans to measure the size of your swollen gland, ask you about your pain levels, and check for any skin changes or if you need any extra procedures like draining. They would also take blood samples to check your overall health and how your body is responding. The total duration of active participation and follow-up for this study is roughly 28 days.
Potential risks and benefits
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Common questions
What is cat scratch disease?
It's an infection you can get from a cat scratch or bite, often leading to swollen glands, sometimes with fever or tiredness.
What is the main goal of this study?
To see if injecting an antibiotic directly into a swollen gland works better to shrink it and reduce the need for more treatments.
Will I know which treatment I'm getting?
No, because it's a 'randomised' study, you won't know which treatment group you're in until after the study is complete, to keep the results fair.
How long will I be involved in the study?
Your active involvement will typically last for about 28 days, with several check-up visits during that time.
Can I stop participating in the study if I change my mind?
Yes, you can choose to leave the study at any time without having to give a reason, and it won't affect your future medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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