HemodialysisPANTHEMNCT05248620

Prophylactic Antibiotic Treatment in Hemodialysis

A study of Hemodialysis, run by Zealand University Hospital at 7 sites in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hemodialysis
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 800 participants
Where: 7 sitesDenmark
Study dates: 14 Feb 2022to May 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

7 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Niels E Bruun, Professor contact

+4525159309

nbru@regionsjaelland.dk

Kasper K Iversen, Professor contact

Kasper.Karmark.Iversen@regionh.dk

City, postcode or hospital

Sites recruiting now only

7 sites in 1 country

Denmark7 sites, 7 recruiting

Aalborg University Hospital
Aalborg, North Region, 9100
Bo Madsen, Consultant, bom@rn.dk
Recruiting
Aarhus University Hospital
Aarhus, Middle Region, 8200
Jens D Jensen, Consultant, jenjesen@rm.dk
Not yet recruiting
Rigshospitalet
Copenhagen, Capital Region, 2100
Marianne Rix, Consultant, Marianne.Rix@regionh.dk
Anne-Lise Kamper, Consultant
Not yet recruiting
Herlev-Gentofte Hospital
Copenhagen, Capital Region, 2730
Henrik P Hansen, Consultant, Henrik.Post.Hansen@regionh.dk
Kasper K Iversen, Professor
Recruiting
North Zealand Hospital Hillerød
Hillerød, Capital Region, 3400
Marianne Bertelsen, Consultant, marianne.camilla.bertelsen@regionh.dk
Not yet recruiting
Odense University Hospital
Odense, Region South, 5000
Per B Jensen, Consultant, Per.Bruno.Jensen@rsyd.dk
Recruiting
ZUH Roskilde
Roskilde, Region Sjælland, 4000
Niels E Bruun, Professor, +4525159309, nbru@regionsjaelland.dk
Rikke Borg, Consultant, rbor@regionsjaelland.dk
Recruiting

Other trials in Denmark

About this study

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

Read the 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.

Conditions: Hemodialysis
Being tested: Amoxicillin Clavulanic 500/125mg or placebo
Keywords: Blood stream infections, Severe culture negative infections, Central venous catheter, Hemodialysis, Antibiotic prophylaxis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amoxicillin Clavulanic 500/125mg or placeboDrug
Also called Aurobindo
Prophylactic antibiotic treatment

Study groups in NCT05248620
Study group	Role	What they receive
Active	Active comparator	Amoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months Receives: Drug: Amoxicillin Clavulanic 500/125mg or placebo
Placebo	Placebo comparator	Placebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months Receives: Drug: Amoxicillin Clavulanic 500/125mg or placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of patients with Blood stream infection (BSI)
Hospitalization for BSI
Measured: ≤ 6 months after randomization
Number of patients with Severe blood culture negative infection
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
Measured: ≤ 6 months after randomization

Secondary outcomes (2)

Number of patients with BSI or severe blood culture negative infection
Each of the components in the primary endpoint
Measured: ≤ 6 months after randomization
Mortality
All-cause mortality
Measured: ≤ 6 months after randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Feb 2022May 2029

First posted21 Feb 2022
Study start14 Feb 2022
Primary completionOct 2028 (estimated)
Study completionMay 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for HemodialysisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Multicenter, randomized, single-blinded, placebo controlled study, with blinded endpoint evaluation
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 800 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05248620
Sponsor's protocol ID: H-20026735
Acronym: PANTHEM
Status last verified: Sep 2026
First submitted: 8 Feb 2022
Last updated: 10 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: No plan

Publications

Gupta V, Yassin MH. Infection and hemodialysis access: an updated review. Infect Disord Drug Targets. 2013 Jun;13(3):196-205. doi: 10.2174/1871526511313030008.
PubMed 24001331
Vogelzang JL, van Stralen KJ, Noordzij M, Diez JA, Carrero JJ, Couchoud C, Dekker FW, Finne P, Fouque D, Heaf JG, Hoitsma A, Leivestad T, de Meester J, Metcalfe W, Palsson R, Postorino M, Ravani P, Vanholder R, Wallner M, Wanner C, Groothoff JW, Jager KJ. Mortality from infections and malignancies in patients treated with renal replacement therapy: data from the ERA-EDTA registry. Nephrol Dial Transplant. 2015 Jun;30(6):1028-37. doi: 10.1093/ndt/gfv007. Epub 2015 Jan 29.
PubMed 25637641
Aslam S, Vaida F, Ritter M, Mehta RL. Systematic review and meta-analysis on management of hemodialysis catheter-related bacteremia. J Am Soc Nephrol. 2014 Dec;25(12):2927-41. doi: 10.1681/ASN.2013091009. Epub 2014 May 22.
PubMed 24854263
Sarnak MJ, Jaber BL. Mortality caused by sepsis in patients with end-stage renal disease compared with the general population. Kidney Int. 2000 Oct;58(4):1758-64. doi: 10.1111/j.1523-1755.2000.00337.x.
PubMed 11012910
Jaber BL. Bacterial infections in hemodialysis patients: pathogenesis and prevention. Kidney Int. 2005 Jun;67(6):2508-19. doi: 10.1111/j.1523-1755.2005.00364.x. No abstract available.
PubMed 15882306
de Jager DJ, Grootendorst DC, Jager KJ, van Dijk PC, Tomas LM, Ansell D, Collart F, Finne P, Heaf JG, De Meester J, Wetzels JF, Rosendaal FR, Dekker FW. Cardiovascular and noncardiovascular mortality among patients starting dialysis. JAMA. 2009 Oct 28;302(16):1782-9. doi: 10.1001/jama.2009.1488.
PubMed 19861670
Chaudry MS, Gislason GH, Kamper AL, Rix M, Dahl A, Ostergaard L, Fosbol EL, Lauridsen TK, Oestergaard LB, Hassager C, Torp-Pedersen C, Bruun NE. The impact of hemodialysis on mortality risk and cause of death in Staphylococcus aureus endocarditis. BMC Nephrol. 2018 Sep 3;19(1):216. doi: 10.1186/s12882-018-1016-0.
PubMed 30176809
Chaudry MS, Carlson N, Gislason GH, Kamper AL, Rix M, Fowler VG Jr, Torp-Pedersen C, Bruun NE. Risk of Infective Endocarditis in Patients with End Stage Renal Disease. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1814-1822. doi: 10.2215/CJN.02320317. Epub 2017 Oct 3.
PubMed 28974524
Nelveg-Kristensen KE, Laier GH, Heaf JG. Risk of death after first-time blood stream infection in incident dialysis patients with specific consideration on vascular access and comorbidity. BMC Infect Dis. 2018 Dec 20;18(1):688. doi: 10.1186/s12879-018-3594-7.
PubMed 30572826
Sakhuja A, Nanchal RS, Gupta S, Amer H, Kumar G, Albright RC, Kashani KB. Trends and Outcomes of Severe Sepsis in Patients on Maintenance Dialysis. Am J Nephrol. 2016;43(2):97-103. doi: 10.1159/000444684. Epub 2016 Mar 10.
PubMed 26959243

Interested in taking part?

Niels E Bruun, Professor

+4525159309

nbru@regionsjaelland.dk

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Manual Acupuncture for Intradialytic Nausea and Vomiting in Patients Undergoing Hemodialysis: A Randomized Controlled Trial
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All Hemodialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prophylactic Antibiotic Treatment in End Stage Kidney Disease and Central Venous Catheter as Hemodialysis Vascular Access
ClinicalTrials.gov ID: NCT05248620
Acronym / sponsor ID: PANTHEM / H-20026735
Conditions: Hemodialysis
Keywords: Blood stream infections, Severe culture negative infections, Central venous catheter, Hemodialysis, Antibiotic prophylaxis
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 800 participants (estimated)
Lead sponsor: Zealand University HospitalUniversity, hospital or other
Collaborators: Herlev Hospital, Copenhagen University Hospital, Rigshospitalet, Holbaek Sygehus, Nordsjaellands Hospital, Odense University Hospital, Aarhus University Hospital, Kolding Sygehus, Gødstrup Hospital, Viborg Regional Hospital, Aalborg University Hospital, Esbjerg Hospital - University Hospital of Southern Denmark, Hospital of Southern Jutland
Study start: 14 Feb 2022 (actual)
Primary completion: Oct 2028 (estimated)
Study completion: May 2029 (estimated)
First posted: 21 Feb 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2
Model description: Multicenter, randomized, single-blinded, placebo controlled study, with blinded endpoint evaluation

Arm	Type	Receives
Active	Active comparator	Drug: Amoxicillin Clavulanic 500/125mg or placeboAmoxicillin/clavulanic acid 500/125mg, tablets, will be administered before each hemodialysis for 6 months
Placebo	Placebo comparator	Drug: Amoxicillin Clavulanic 500/125mg or placeboPlacebo tablets, similar to the active drug, will be administered before each hemodialysis for 6 months

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amoxicillin Clavulanic 500/125mg or placeboAlso: AurobindoProphylactic antibiotic treatment	Drug	Active, Placebo

Primary outcome

Number of patients with Blood stream infection (BSI)
Time frame: ≤ 6 months after randomization
Hospitalization for BSI
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

2 secondary outcomes

Number of patients with BSI or severe blood culture negative infection
Time frame: ≤ 6 months after randomization
Mortality
Time frame: ≤ 6 months after randomization

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
Background: PubMed 24001331Gupta V, Yassin MH. Infection and hemodialysis access: an updated review. Infect Disord Drug Targets. 2013 Jun;13(3):196-205. doi: 10.2174/1871526511313030008.
Background: PubMed 25637641Vogelzang JL, van Stralen KJ, Noordzij M, Diez JA, Carrero JJ, Couchoud C, Dekker FW, Finne P, Fouque D, Heaf JG, Hoitsma A, Leivestad T, de Meester J, Metcalfe W, Palsson R, Postorino M, Ravani P, Vanholder R, Wallner M, Wanner C, Groothoff JW, Jager KJ. Mortality from infections and malignancies in patients treated with renal replacement therapy: data from the ERA-EDTA registry. Nephrol Dial Transplant. 2015 Jun;30(6):1028-37. doi: 10.1093/ndt/gfv007. Epub 2015 Jan 29.
Background: PubMed 24854263Aslam S, Vaida F, Ritter M, Mehta RL. Systematic review and meta-analysis on management of hemodialysis catheter-related bacteremia. J Am Soc Nephrol. 2014 Dec;25(12):2927-41. doi: 10.1681/ASN.2013091009. Epub 2014 May 22.
Background: PubMed 11012910Sarnak MJ, Jaber BL. Mortality caused by sepsis in patients with end-stage renal disease compared with the general population. Kidney Int. 2000 Oct;58(4):1758-64. doi: 10.1111/j.1523-1755.2000.00337.x.
Background: PubMed 15882306Jaber BL. Bacterial infections in hemodialysis patients: pathogenesis and prevention. Kidney Int. 2005 Jun;67(6):2508-19. doi: 10.1111/j.1523-1755.2005.00364.x. No abstract available.
Background: PubMed 19861670de Jager DJ, Grootendorst DC, Jager KJ, van Dijk PC, Tomas LM, Ansell D, Collart F, Finne P, Heaf JG, De Meester J, Wetzels JF, Rosendaal FR, Dekker FW. Cardiovascular and noncardiovascular mortality among patients starting dialysis. JAMA. 2009 Oct 28;302(16):1782-9. doi: 10.1001/jama.2009.1488.
Background: PubMed 30176809Chaudry MS, Gislason GH, Kamper AL, Rix M, Dahl A, Ostergaard L, Fosbol EL, Lauridsen TK, Oestergaard LB, Hassager C, Torp-Pedersen C, Bruun NE. The impact of hemodialysis on mortality risk and cause of death in Staphylococcus aureus endocarditis. BMC Nephrol. 2018 Sep 3;19(1):216. doi: 10.1186/s12882-018-1016-0.
Background: PubMed 28974524Chaudry MS, Carlson N, Gislason GH, Kamper AL, Rix M, Fowler VG Jr, Torp-Pedersen C, Bruun NE. Risk of Infective Endocarditis in Patients with End Stage Renal Disease. Clin J Am Soc Nephrol. 2017 Nov 7;12(11):1814-1822. doi: 10.2215/CJN.02320317. Epub 2017 Oct 3.
Background: PubMed 30572826Nelveg-Kristensen KE, Laier GH, Heaf JG. Risk of death after first-time blood stream infection in incident dialysis patients with specific consideration on vascular access and comorbidity. BMC Infect Dis. 2018 Dec 20;18(1):688. doi: 10.1186/s12879-018-3594-7.
Background: PubMed 26959243Sakhuja A, Nanchal RS, Gupta S, Amer H, Kumar G, Albright RC, Kashani KB. Trends and Outcomes of Severe Sepsis in Patients on Maintenance Dialysis. Am J Nephrol. 2016;43(2):97-103. doi: 10.1159/000444684. Epub 2016 Mar 10.
Individual participant dataSharing planned: No. No plan

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Niels E Bruun, Professor contact

+4525159309

nbru@regionsjaelland.dk

Kasper K Iversen, Professor contact

Kasper.Karmark.Iversen@regionh.dk

Niels E Bruun, Professor principal investigator

Dept. cardiology, Zealand University Hospital, Roskilde, Denmark

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study of Hemodialysis, run by Zealand University Hospital at 7 sites in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Niels E Bruun, Professor (+4525159309, nbru@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with Blood stream infection (BSI) (time frame: ≤ 6 months after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05248620, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.