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Ciprofloxacin use to prevent infections in children with Acute Lymphoblastic Leukaemia

CiproPAL (Ciprofloxacin Prophylaxis in Acute Leukaemia): A Randomised Trial to Assess the Use of Ciprofloxacin Prophylaxis to Prevent Bacterial Infection in Children Treated on the Induction Phase of the ALLTogether-1 Treatment Protocol

Not applicable Interventional University College, London · NCT04678869

This study is testing if giving children with Acute Lymphoblastic Leukaemia daily ciprofloxacin can help prevent infections during their initial treatment phase.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment1052 (estimated)
Ages1 Year to 17 Years
SexAll
SponsorUniversity College, London Academic / other
Locations14 sites (Aberdeen and 13 other locations)
Trial IDNCT04678869 on ClinicalTrials.gov

What this trial studies

CiproPAL is a randomized trial that compares the use of daily ciprofloxacin to local standard care during the induction phase of treatment for pediatric Acute Lymphoblastic Leukaemia (ALL). The trial aims to assess the efficacy of ciprofloxacin in reducing infections during this critical treatment phase and to evaluate its impact on antimicrobial resistance. Participants aged 1-17 years with de-novo ALL will be enrolled, and the study will monitor various infection-related outcomes and antibiotic resistance over time. The primary outcome is the rate of sterile site bacterial infections, with secondary outcomes including febrile episodes and severe infections.

Who should consider this trial

Good fit: Ideal candidates are pediatric patients aged 1-17 years with newly diagnosed Acute Lymphoblastic Leukaemia who are participating in the ALLTogether-1 trial.

Not a fit: Patients with Down syndrome who are already receiving ciprofloxacin prophylaxis or those with contraindications to fluoroquinolones will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly reduce infection rates in children undergoing treatment for Acute Lymphoblastic Leukaemia.

How similar studies have performed: Other studies have shown promising results with antibiotic prophylaxis in similar patient populations, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Paediatric patients (1-17 years inclusive) with de-novo Acute Lymphoblastic Leukaemia treated on ALLTogether-1 in the UK in the first 5 days of therapy, up to 14 days is acceptable.
* Written informed consent

Exclusion Criteria:

* Non-participants of the ALLTogether-1 trial
* Patients with Down syndrome who already receive ciprofloxacin prophylaxis
* Chronic active arthritis
* Other contraindication to fluoroquinolones

Where this trial is running

Aberdeen and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Lymphoblastic Leukaemia - Categoryantibiotic prophylaxis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.