All studies
Active not recruitingNAINTERVENTIONAL

CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia)

The CiproPAL study is designed for children aged 1 to 17 years who are starting treatment for Acute Lymphoblastic Leukaemia (ALL), a type of blood cancer. This study aims to see if giving a daily antibiotic called ciprofloxacin can help prevent infections during the initial phase of their cancer treatment. Children will be randomly assigned to either receive ciprofloxacin or the usual care. Researchers will then compare how many infections each group gets. Another important part of the study is to understand if using ciprofloxacin affects how bacteria respond to antibiotics, which is known as antibiotic resistance. This helps doctors learn the best ways to protect children undergoing cancer treatment from serious infections.

At a glance

Status
Active not recruiting
Phase
NA
Sponsor
University College, London
Enrolment target
313
Start
29 Jun 2022
Estimated completion
01 Jun 2028

What is this study about?

Imagine your child has just been diagnosed with Acute Lymphoblastic Leukaemia (ALL), a type of blood cancer. Treatment for ALL often involves strong medications that can make fighting off infections very difficult. This is because these medications temporarily reduce the number of white blood cells, which are your body's infection-fighting cells.

This study, called CiproPAL, is looking into whether a specific antibiotic, ciprofloxacin, can help protect children aged 1 to 17 from getting infections during the early part of their ALL treatment. During this time, children are often more vulnerable to germs. The idea is to see if taking ciprofloxacin regularly can reduce the chance of getting a serious bacterial infection.

Children taking part will be randomly put into one of two groups: one group will receive ciprofloxacin daily, and the other will continue with the usual care their hospital provides. Doctors will then carefully compare how often children in each group get infections. The study also aims to understand how using ciprofloxacin might affect how bacteria become resistant to antibiotics over time, which is important for future treatments. Your child's doctor will be able to tell you if this study might be right for your child.

Key takeaways

  • The study investigates if ciprofloxacin reduces infections in children with ALL.
  • It's for children aged 1-17 starting ALL treatment.
  • Children will be assigned to either ciprofloxacin or standard care.
  • Researchers will also study how antibiotics affect bacterial resistance.
  • Participation involves taking medication (for one group) and providing samples for testing.
  • Your child's participation is entirely voluntary and can be stopped at any time.

Who may be eligible?

This study is particularly for children and teenagers between 1 and 17 years old who have recently been diagnosed with Acute Lymphoblastic Leukaemia (ALL). They must be receiving their ALL treatment as part of another main study called ALLTogether-1 in the UK.

Your child can participate if they are starting their ALL treatment within the first five days, though up to 14 days is also acceptable. Most importantly, you, as their parent or guardian, must agree for your child to take part in both the ALLTogether-1 study and the CiproPAL study.

There are a few reasons why a child might not be able to join. For example, if they have Down syndrome (because they usually receive ciprofloxacin already) or if they have certain conditions that mean they can't take antibiotics like ciprofloxacin. They also cannot join if they are not part of the main ALLTogether-1 study.

Quick self-check
  • Is my child between 1 and 17 years old?
  • Has my child been recently diagnosed with Acute Lymphoblastic Leukaemia (ALL)?
  • Is my child already part of the ALLTogether-1 treatment study?
  • Is it within 14 days of my child starting their ALL treatment?
  • Does my child have any known reasons not to take ciprofloxacin (e.g., allergies)?
  • Does my child have Down syndrome (they cannot participate as they get ciprofloxacin already)?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If your child takes part in the CiproPAL study, they will be randomly assigned to one of two groups: either receiving daily ciprofloxacin or continuing with standard care. This will happen during the initial 'induction' phase of their ALL treatment, which is when they are most vulnerable to infections. Ciprofloxacin would be given either by mouth or through a drip, twice a day.

Throughout the first year, doctors will take small samples, like stool (poo) or swabs from around the bottom, at five different times. These samples help check how bacteria in your child's body are responding to antibiotics. If your child gets an infection, doctors will also test the bacteria from that infection to see which antibiotics work against it. All these checks are part of your child's regular ALL treatment and hospital visits. The study itself won't add many extra appointments, but it will involve specific monitoring and, for one group, taking the study medication. The overall monitoring for antibiotic resistance will continue for the duration of the main ALLTogether-1 trial.

Potential risks and benefits

Taking part in this study may offer the potential benefit of reducing the chance of your child getting a serious infection during a very critical time in their cancer treatment. However, like all medications, ciprofloxacin can have side effects. While usually rare, possible side effects might include issues like tummy upsets or, very rarely, joint problems. The study also helps us understand more about antibiotic resistance, which benefits everyone in the long run. You and your child have the right to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (14)

  • Royal Aberdeen Children's Hospital
    Aberdeen, United Kingdom
  • Bristol Royal Hospital for Children
    Bristol, United Kingdom
  • Addenbrookes Hospital
    Cambridge, United Kingdom
  • Leeds General Infirmary
    Leeds, United Kingdom
  • Leicester Royal Infirmary
    Leicester, United Kingdom
  • Alder Hey Children's Hospital
    Liverpool, United Kingdom
  • Great Ormond Street Hospital
    London, United Kingdom
  • Univeristy College Hospital London
    London, United Kingdom
  • Royal Manchester Children's Hospital
    Manchester, United Kingdom
  • Royal Victoria Infirmary
    Newcastle, United Kingdom
  • Nottingham Children's Hospital
    Nottingham, United Kingdom
  • John Radcliffe Hospital
    Oxford, United Kingdom

+2 more sites — see the official record for the full list.

Common questions

What is Acute Lymphoblastic Leukaemia (ALL)?

ALL is a type of cancer that starts in the white blood cells in the bone marrow, which is the soft, spongy tissue inside bones.

What is ciprofloxacin?

Ciprofloxacin is an antibiotic, a type of medicine used to treat or prevent infections caused by bacteria.

Why might my child need an antibiotic to prevent infection?

ALL treatments can weaken the immune system, making children more likely to get serious infections. Prophylaxis means giving medicine to prevent something from happening.

What is 'standard care'?

Standard care means the usual, recommended medical treatment that doctors provide for ALL, without the added ciprofloxacin for prevention in this study.

What is antibiotic resistance?

Antibiotic resistance happens when bacteria change and no longer respond to the antibiotics designed to kill them. This makes infections harder to treat.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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