Prophylactic Antibiotic Treatment in Hemodialysis (PANTHEM)

September 7, 2026 updated by: Zealand University Hospital

Prophylactic Antibiotic Treatment in End Stage Kidney Disease and Central Venous Catheter as Hemodialysis Vascular Access

The purpose of this study is to assess the efficacy of prophylactic antibiotic treatment on blood stream infections and severe culture negative infections, in patients on newly started hemodialysis(HD), with a central venous catheter as vascular access.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

After being informed about the study and potential risks all eligible patients, giving written informed consent will be included in the study. At week 0 patients will be randomized in a single blinded manner (participants and care providers) in a 1:1 manner to receive 500/125mg amoxicillin/clavulanic acid 30-120 minutes before each hemodialysis with a central venous catheter (CVC) as vascular access, or corresponding placebo. The timing of antibiotic administration has been established in a pilot-study in order to secure a sufficient concentration of antibiotics during the dialysis session. In case of side effects to amoxicillin/clavulanic acid, the prophylactic antibiotic will be shifted to 600mg clindamycin. Total treatment period with prophylactic antibiotics is 6 months, with a 1 year follow-up.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Denmark
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Not yet recruiting
        • Rigshospitalet
        • Contact:
        • Contact:
          • Anne-Lise Kamper, Consultant
      • Copenhagen, Capital Region, Denmark, 2730
        • Recruiting
        • Herlev-Gentofte Hospital
        • Contact:
        • Contact:
          • Kasper K Iversen, Professor
      • Hillerød, Capital Region, Denmark, 3400
    • Middle Region
      • Aarhus, Middle Region, Denmark, 8200
        • Not yet recruiting
        • Aarhus University Hospital
        • Contact:
    • North Region
      • Aalborg, North Region, Denmark, 9100
        • Recruiting
        • Aalborg University Hospital
        • Contact:
    • Region Sjælland
    • Region South
      • Odense, Region South, Denmark, 5000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • End Stage Kidney Disease (ESKD) patients who receive an uncuffed or cuffed CVC for expected chronic HD, regardless of previous ESKD treatment modality (PD or KTX) and hemodialysis access (AV-fistula or AV-graft))
  • ≥18 years
  • Ability to understand the study background, risk and benefit of treatment and to give written informed consent

Exclusion Criteria:

  • Unable to give informed consent
  • Known intolerance to beta-lactam antibiotics and clindamycin
  • Active infection treated with antibiotics
  • Breastfeeding
  • Pregnancy. In women of childbearing age, an approved birth control must be ensured at least 1 month before and during all the 6 months of antibiotic/placebo treatment.

Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active
Amoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months
Drug: Amoxicillin Clavulanic 500/125mg or placebo
Prophylactic antibiotic treatment
Other Names:
  • Aurobindo
Placebo Comparator: Placebo
Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months
Drug: Amoxicillin Clavulanic 500/125mg or placebo
Prophylactic antibiotic treatment
Other Names:
  • Aurobindo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of patients with Blood stream infection (BSI)
Time Frame: ≤ 6 months after randomization
Hospitalization for BSI
≤ 6 months after randomization
Number of patients with Severe blood culture negative infection
Time Frame: ≤ 6 months after randomization
Hospitalization ≥ 3 days, or dies within 3 days, due to infection defined as: C-reactive protein (CRP) ≥ 75 and negative blood cultures, treated with iv antibiotics
≤ 6 months after randomization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with BSI or severe blood culture negative infection
Time Frame: ≤ 6 months after randomization
Each of the components in the primary endpoint
≤ 6 months after randomization
Mortality
Time Frame: ≤ 6 months after randomization
All-cause mortality
≤ 6 months after randomization

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of patients with Sepsis
Time Frame: ≤ 6 months after randomization
Hospitalization due to sepsis or septic shock
≤ 6 months after randomization
Number of patients with Deep tissue infection
Time Frame: ≤ 6 months after randomization
Infective endocarditis, osteomyelitis, and spondylodiscitis
≤ 6 months after randomization
Number of patients with Autoinfection
Time Frame: ≤ 6 months after randomization
Frequency of BSI autoinfection
≤ 6 months after randomization
Number of patients with Clostridium difficile infection
Time Frame: ≤ 6 months after randomization
Clostridium difficile infection - numbers and days of admission
≤ 6 months after randomization
Mortality due to infection - number of patients
Time Frame: ≤ 6 months after randomization
Mortality due to infection
≤ 6 months after randomization
Number of CVC removals
Time Frame: ≤ 6 months after randomization
CVC removal due to CVC infection
≤ 6 months after randomization
Use of Antibiotics in Difined Daily Doses
Time Frame: ≤ 6 months after randomization
Total use of antibiotics in Defined Daily Doses
≤ 6 months after randomization
Healt-care economics
Time Frame: ≤ 6 months after randomization
Health-care related economic consequences due to hospitalization and treatment of the disease
≤ 6 months after randomization
Number of patients with Extended Spectrum Beta-Lactamase (ESBL) infection
Time Frame: ≤ 6 months after randomization
ESBL infections - number of patients and days of admission
≤ 6 months after randomization
Number of patients with Methicillin-resistant Staphylococcus aureus (MRSA) infection
Time Frame: ≤ 6 months after randomization
MRSA infections - number of patients and days of admission
≤ 6 months after randomization
Number of patients with Carbapenemase-Producing Organisms (CPO) infection
Time Frame: ≤ 6 months after randomization
CPO infections - number og patients and days of admission
≤ 6 months after randomization
Number of patients with Vancomycin-resistant enterococci (VRE) infection
Time Frame: ≤ 6 months after randomization
VRE infections - number of patients and days of admission
≤ 6 months after randomization
Number of patients with Cardiovascular events
Time Frame: ≤ 6 months after randomization
Hospitalization with acute myocardial infarction, worsening heart failure or stroke
≤ 6 months after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zealand University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Odense University Hospital
Aarhus University Hospital
Rigshospitalet, Denmark
Herlev Hospital
Aalborg University Hospital
Holbaek Sygehus
Gødstrup Hospital
Kolding Sygehus
Nordsjaellands Hospital
Viborg Regional Hospital
Hospital of Southern Jutland
Esbjerg Hospital - University Hospital of Southern Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Niels E Bruun, Professor, Dept. cardiology, Zealand University Hospital, Roskilde, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-20026735

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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