CompletedNot Applicable

ATAPAC Study (TauroLock Activity in Adult Cancer Patients)

France162 participantsStarted 2014-11

Plain-language summary

The purpose of this study is to compare the efficacy of a lock taurolidine-citrate solution vs standard saline solution for primary prevention of central venous catheter-associated bloodstream infection in adult patients treated with intra-venous therapy for a solid tumor

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients older than 18 years * Performance Index (WHO score) ≤ 2 * Patient with a solid cancer receiving an IV anti-tumor treatment * Presence of a totally implantable CVC * Anti-tumoral therapy administered by a totally implantable CVC * Metastatic and / or (neo) adjuvant treatment * Full hospitalised and / or day-hospital patients * Informed written consent * Social Health security insurance Exclusion Criteria: * Hematological cancer patients * HIV-positive patients and/ or patients receiving an active immunosuppressive therapy * Patients presenting a febrile episode within 4 days prior to randomisation * Patients with neutropenia grade ≥ 2 (ANC ≤ 1000/mm3) on a blood testing older than 7 days * Patients on IV antibiotic therapy * Patients on total and / or peripheral parental nutrition * Patients with a previous CLABSI history * Allergy to citrate or taurolidine * Patients who are not able to give an informed consent * Patients under guardianship * Patients under judicial protection * Pregnant or breastfeeding woman

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

central venous catheter-associated bloodstream infection (CLABSI)

Timeframe: during the IV anti-tumor treatment + 1 month of follow-up = 5 months on average and for up to 11 months

Trial details

NCT IDNCT02279121

SponsorCentre Hospitalier Régional Metz-Thionville

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-03

View on ClinicalTrials.gov More Catheter-Related Infections trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.