Clinical trial · Interventional
CiproPAL (Ciprofloxacin Prophylaxis in Acute 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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
CiproPAL is a randomised trial comparing daily ciprofloxacin with local standard care during the induction phase of paediatric ALL treatment, and aims: 1. To assess the efficacy of ciprofloxacin prophylaxis in the reduction of infection during the induction phase of treatment for paediatric Acute Lymphoblastic Leukaemia within the ALLTogether-1 Trial. 2. To evaluate the impact of ciprofloxacin prophylaxis on antimicrobial resistance, both of invasive infections and colonising organisms.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukaemia - Category | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Antibiotic | Drug | — | UNRESOLVED |
| Ciprofloxacin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Cirprofloxacin prophylaxis
- description
- prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
- interventionNames
- Drug: Ciprofloxacin
- type
- ACTIVE_COMPARATOR
- label
- Standard of care
- description
- standard of care
- interventionNames
- Drug: Antibiotic
Primary outcomes (1)
- measure
- rate of sterile site bacterial infections during induction
- timeFrame
- during induction approx 1 month (from randomisation until the start of consolidation, discontinuing protocol antileukaemic therapy or death post induction)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 17 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available