BACKGROUND~Patients with cancer and a long-term central venous access device (CVAD), including tunneled lines and ports, are at risk of developing central line-associated bloodstream infections (CLABSI). A patient with CLABSI is treated with systemic antibiotic therapy. Additionally, prompt removal of CVAD because of CLABSI is often recommended. However, removal and replacement of long-term CVAD in children and adolescents with cancer is often highly complicated due to limited vascular access, refractory thrombocytopenia, or critical need for central access, and thus CVAD-salvage is attempted. In Denmark, hydrochloric acid lock therapy (HALT) has been used routinely to all children and adolescents with cancer and CLABSI. However, HALT is not recommended outside Denmark due to limited evidence of its use.~PATIENT AND METHODS~Eligible patients with CLABSI (defined as a laboratory-confirmed bloodstream infection, not secondary to infection at another site, in a patient who has a CVAD) will be enrolled within 48 hours after detection of a positive blood culture/CLABSI and randomized to receive blinded lock therapy with hydrochloric acid (2 M) or placebo (normal saline). HALT and placebo lock therapy is carried out by trained oncologic nurses in identical fashion: Hydrochloric acid or normal saline in a volume corresponding to dead space (0.3-1.0ml) will be instilled and aspirated 10 min later; the instillation is completed 3 times. In addition to the study intervention, participants in both arms will receive standard systemic antibiotic therapy according to the preference of the ward clinician.~The patient is followed 6 weeks from instillation with HALT/placebo. The patient will be re-included if the patient has a CLABSI later than 6 weeks from a previous CLABSI. In case of re-inclusion the patient will cross over to the opposite group (intervention/HALT or placebo/normal saline respectively).
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.