Efficacy of an empirical treatment with Amoxicillin-clavulanate (AC) compared to the combination Amoxicillin-clavulanate and Ciprofloxacin (AC+C) in the outpatient care of chemotherapy-induced fever in adult haematology patients. AC-CIF Protocol
This study is for adult patients with blood cancers who are having chemotherapy. Chemotherapy can sometimes weaken the immune system, leading to a fever. This study compares two different combinations of antibiotics given early on to treat this fever. One group receives Amoxicillin-clavulanate (a common antibiotic), and the other group receives Amoxicillin-clavulanate plus Ciprofloxacin (another antibiotic). Researchers want to see which treatment is more successful in clearing the fever within four days without needing to switch medicines. They will also look at whether patients need to be hospitalised, if the fever comes back, and any side effects. The goal is to find the best way to treat these fevers and keep patients well.
At a glance
What is this study about?
This study is designed for adults who are being treated for conditions affecting their blood (like leukaemia or lymphoma) with chemotherapy. A common side effect of chemotherapy is that it can temporarily lower the number of white blood cells that fight infection. This makes people more likely to get infections and develop a fever. When this happens, doctors often give antibiotics straight away to prevent serious problems.
This research is comparing two standard approaches to giving antibiotics. One group of patients will receive a combination of antibiotics called Amoxicillin-clavulanate. The other group will receive Amoxicillin-clavulanate plus another antibiotic called Ciprofloxacin. The main aim is to see which of these two combinations is more effective at making the fever go away within four days, without doctors having to change the original antibiotic treatment.
By comparing these two treatments, doctors hope to find out if adding Ciprofloxacin makes a significant difference to how well patients recover. This information could help doctors in the future choose the best initial antibiotic treatment for patients experiencing fever after chemotherapy, ultimately aiming to improve patient care and outcomes.
Key takeaways
- Compares two antibiotic treatments for fever in cancer patients.
- Aims to find the most effective and safest antibiotic combination.
- Studies adults with blood conditions receiving chemotherapy.
- Involves taking specific antibiotics and having regular follow-ups.
- Follow-up lasts about 30 days.
- Participation is voluntary and you can withdraw at any time.
Who may be eligible?
This study is looking for adults aged 18 and over, of any gender. To be considered, you must be a patient being treated for a blood condition (like certain cancers). You also need to be having chemotherapy that is expected to temporarily lower your white blood cell count for less than seven days. This means your immune system will be weakened for a short time, making you more vulnerable to infections.
Only patients who get a fever while their white blood cell count is low due to chemotherapy are suitable for this study. If you fall into this category, your doctor can discuss whether this study might be right 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?
- Are you currently receiving treatment for a blood condition (like certain cancers)?
- Are you having chemotherapy that is expected to temporarily lower your ability to fight infections for less than seven days?
- Have you developed a fever after your chemotherapy?
What does participation involve?
If you join this study, you would be randomly assigned to receive one of two antibiotic combinations: either Amoxicillin-clavulanate alone, or Amoxicillin-clavulanate with Ciprofloxacin. You would take these antibiotics as prescribed by your doctor. Researchers will then closely monitor your health.
This involves checking if your fever goes away within four days without needing to change your antibiotics. They will also keep an eye out for whether your fever comes back, if you need to be admitted to hospital (or an intensive care unit), or if you experience any side effects from the medication. You will have follow-up phone calls at 48 hours, 14 days, and 30 days after starting the antibiotics. At the 14-day mark, they will also review your medical notes and any test results to gather more information. The total duration of active follow-up for the study will be about 30 days.
Potential risks and benefits
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Common questions
What is chemotherapy-induced fever?
It's a fever that happens when chemotherapy temporarily weakens your immune system, making you more prone to infection.
What are these antibiotics for?
They are used to treat infections that can cause fever when your immune system is weak due to chemotherapy.
Will I know which treatment I'm getting?
You will be randomly assigned to one of the two treatment groups, but the study team will know which you are receiving to monitor you properly.
How long will I be followed in the study?
You will be followed for about 30 days after starting the antibiotics, with follow-up calls and medical record reviews.
Can I stop participating if I want to?
Yes, you can withdraw from the study at any time without it affecting your 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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