Using hydrochloric acid to treat bloodstream infections in cancer patients
Hydrochloric Acid Lock Therapy for Central Line-associated Bloodstream Infections in Patients With Cancer and Hematologic Diseases
This study is testing if using hydrochloric acid to treat bloodstream infections can help cancer patients recover better than standard treatments alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 0 Years to 100 Years |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 4 sites (Aarhus and 3 other locations) |
| Trial ID | NCT05376566 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of hydrochloric acid lock therapy (HALT) in reducing treatment failure rates for central line-associated bloodstream infections (CLABSI) in patients with cancer or hematologic diseases. The study is designed as a multicenter, double-blinded, randomized controlled trial involving a target population of 250 patients across three hospitals in Denmark. Participants will be randomly assigned to receive either HALT or a placebo, alongside standard systemic antibiotic therapy, with follow-up for six weeks post-treatment.
Who should consider this trial
Good fit: Ideal candidates include patients aged 0-100 years with cancer or hematologic disorders who have a central venous access device and a new diagnosis of CLABSI.
Not a fit: Patients who do not have a central venous access device or those with CLABSI secondary to infections at other sites may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients with CLABSI, potentially reducing the need for invasive procedures like catheter removal.
How similar studies have performed: While hydrochloric acid lock therapy has been used in Denmark, its efficacy has not been widely tested outside this context, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria * 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. Exclusion Criteria: * Plan to remove CVAD within 6 days. * Instantly admission to Intensive Care Uni
Where this trial is running
Aarhus and 3 other locations
- Department of Paediatrics and Adolescent Medicine, Aarhus University Hospital — Aarhus, Denmark (Recruiting)
- Department of Haematology, Copenhagen University Hospital — Copenhagen, Denmark (Recruiting)
- Department of Paediatrics and Adolescent Medicine, Copenhagen University Hospital — Copenhagen, Denmark (Recruiting)
- Department of Paediatrics and Adolescent Medicine, Odense University Hospital — Odense, Denmark (Recruiting)
Study contacts
- Study coordinator: Mette B Bondo Mønster, MD
- Email: mette.bondo.moenster@regionh.dk
- Phone: 004541168347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.