NCT05376566Completed
Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections
Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections in Patients With Cancer and Hematologic Diseases
Source: ClinicalTrials.gov · Last updated 24 Mar 2026
Brief summary (registry, in English)
Aim: This study will test whether treatment of central line-associated bloodstream infections (CLABSI) with hydrochloric acid lock therapy (HALT) can significantly reduce the risk of treatment failure (comprising failure to clear initial infection, relapse of infection, or reinfection) in patients treated for cancer or hematologic diseases. Study design: A multicentre, double-blinded, randomized controlled trial. Patient population: Patients (0-100 y) with cancer or a hematologic disorder and a CLABSI treated at Copenhagen University Hospital, Aarhus University Hospital, or Odense University Hospital, Denmark. Randomization: Patients are equally assigned (1:1) to receive either HALT or placebo (normal saline). In addition to the study intervention, patients in both arms will receive standard systemic antibiotic therapy. Sample size: A target population of 250 patients Statistical Analysis Plan is uploaded in "Study Documents"
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 212 (actual)
- First submitted
- 11 May 2022
- Start date
- 1 Jun 2022
- Primary completion date
- 1 Mar 2026
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Diseases
- Childhood cancers
- NCT number
- NCT05376566
What you commit to
- Study type: Interventional
- Participants enrolled: 212
- From 1 Jun 2022 to the primary completion date, 1 Mar 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Plan to remove CVAD within 6 days.
- Instantly admission to Intensive Care Uni
Who the study is looking for
- Patients aged 0-17 years treated at pediatric oncologic department at Copenhagen University Hospital, Odense University Hospital, and Aarhus University Hospital, Denmark. Inclusion of children and adolescents from 1st of June 2022.
- Patients aged 18-100 years treated at Department of Hematology, Copenhagen University Hospital, Denmark. Inclusion of adult patients from 17th of October 2023.
- Patients receiving treatment for cancer or a hematologic disease (any type and at any point in the course of the disease).
- CVAD in situ (intravenous ports and all central lines).
- 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.
- The patient is followed 6 weeks from instillation with HALT/placebo. The patient can be re-included if the patient has 1) replacement of the CVAD, or 2) a new CLABSI later than 6 weeks from a previous CLABSI. In case of re-inclusion the patient, the patient will be randomized again.
Age in the registry: 0 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital Coordinator of this site? Confirm its status | Aarhus | Denmark | Unknown status |
| Department of Haematology, Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
| Department of Paediatrics and Adolescent Medicine, Odense University Hospital Coordinator of this site? Confirm its status | Odense | Denmark | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.