Trial Details
Trial status:
Active (recruiting)
Recruitment start date:
29/06/2022
Funder:
NIHR/HTA
Sponsor:
UCL
Chief Investigator:
Dr Bob Phillips
Recruitment target:
1052
EudraCT number:
2021-000341-40
Contact details:
ctc.cipropal@ucl.ac.uk
Lay summary:
CiproPAL
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 ALLTogether1 treatment protocol.
Description
Design: Multi-centre, randomised open-label trial
Treatment:

Eligible patients who consent to take part inCiproPAL and who are already enrolled inALLTogether1 will be randomised (1:1) to theinterventional arm or control arm of the trial.

Patients randomised to the interventional arm willreceive prophylactic ciprofloxacin (10mg/kg twice aday, enteral or intravenously) from randomisation tothe end of induction. Specifically, prophylacticciprofloxacin should commence as soon as possibleafter randomisation (within the first 5-8 days ofinduction therapy) and continue until neutrophilrecovery sufficient for the commencement ofconsolidation (ANC >0.5x109/L).

Patients randomised to the control arm will receiveno additional treatment during induction. Suchpatients should receive the standard of care, as perlocal policy.

Any febrile episodes should be treated according tolocal guidelines. For patients in the interventionalarm (receiving prophylactic ciprofloxacin),ciprofloxacin prophylaxis should be stopped for theduration of any treatment with broad spectrumantibiotics, empirically or for a defined infection, andre-started afterwards. If antibiotic coverage isrationalised to treat a specific infection, for exampleteicoplanin for a Coagulase negativeStaphylococcus central line infection, thenciprofloxacin should be restarted. If there are anyuncertainties regarding restarting ciprofloxacinplease contact UCL CTC who will enquire with thetrial management group (TMG).

Key inclusion/exclusion criteria:

Inclusion:

• Paediatric patients (1-17 years inclusive) withde-novo Acute Lymphoblastic Leukaemiatreated on ALLTogether1 in the UK in the first 5-8 days of therapy.

• Written informed consent.

Exclusion:

• Non-participants of the ALLTogether1 trial.

• Patients with Down syndrome.

• Patients with chronic active arthritis.

• Patients with any other contraindication tofluoroquinolones.

Duration of recruitment: 42 months
Aim

1. To assess the efficacy of ciprofloxacin prophylaxisin reducing infections during the induction phase ofthe ALLTogether1 Trial.

2. To evaluate the impact of ciprofloxacin prophylaxison antimicrobial resistance, both of invasiveinfections and colonising organisms.

Trial protocols
Trial protocols must not be applied to patients treated outside trials. UCL CTC can only ensure that approved trial investigators are provided with amendments to protocols.
No protocols have been currently made available for download
Trial documents
No documents have been currently made available for download
Contact Us
Cancer Research UK & UCL Cancer Trials Centre
University College London
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London
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Email:
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Telephone:
+44 (0)20 7679 9898 (General CTC Enquiries)
Fax:
020 7679 9899
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