Hydrochloric Acid Lock Therapy in Children With Cancer

• Status: Not yet recruiting
• Trial end date: 2024-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Aim: This study will test whether treatment of central line associated bloodstream infection (CLABSI) with hydrochloric acid lock therapy (HALT) can significantly reduce the risk of treatment failure (comprising failure to clear initial infection, relapse or reinfection) in children and adolescents treated for cancer.

Study design: A multicenter, double-blind, randomized controlled trial.The assignment is parallel, with cross-over in case of reinclusion of the patient.

Patients and randomisation: A target population of 100 children and adolescents treated for cancer will be enrolled within 48 hours after detection of a positive blood culture/CLABSI. They will be randomized as followed:

• Intervention group: HALT.

• Control group: Normal saline (placebo).

In addition to the study intervention, participants in both arms will receive standard systemic antibiotic therapy according to the preference of the ward clinician.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rigshospitalet, Denmark
• Collaborators: Aarhus University Hospital Skejby; Odense University Hospital

Criteria

Inclusion Criteria:

• Patients aged 0-17 years. NB, In case of slow recruitment, patients aged 17-30 years will also be included.

• Patients receiving treatment for cancer (any type and at any point in the course of the disease).

• CVAD in situ (port-a-cath and all central lines incl. PICC-line catheter).

• New diagnosis of CLABSI (defined as a laboratory-confirmed bloodstream infection, not secondary to infection at another site, in a patient who has a CVAD). NB, patients who had a CLABSI prior to the beginning of the study are accepted for enrollment if they have a new CLABSI during the patient enrollment phase.

Participants are followed for 6 weeks from HALT/placebo. In case of a CLABSI later than 6 weeks from a previous CLABSI, the patient will be re-included in the opposite group (cross-over allocation for reincluded patients).

Exclusion Criteria:

• Plan to remove CVAD within 6 days.

• Instantly admission to Intensive Care Unit.