Overview
Sponsor-declared trial summary
Blood poisoning in patients with renal failure treated with hemodialysis
In a randomised placebo-controlled trial to evaluate the effect of prophylactic antibiotic treatment with amoxicillin/clavulanic acid (or clindamycin if beta-lactam intolerant), administered in relation to the HD procedure on: BSI and severe blood culture negative infection, during the first 6 months after initiation o…
Key facts
- Sponsor
- Region Sjaelland
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Bacterial Infections and Mycoses [C01]
- Trial duration
- 25 Jul 2024 → ongoing
- Decision date (initial)
- 2024-07-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Kaj Hansen Foundation · NOVO Nordisk Fundation · Health Insurance Denmark · Augustinus Foundation
External identifiers
- EU CT number
- 2024-515001-26-00
- EudraCT number
- 2020-001033-12
- ClinicalTrials.gov
- NCT05248620
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis, Pharmacokinetic
In a randomised placebo-controlled trial to evaluate the effect of prophylactic antibiotic treatment with amoxicillin/clavulanic acid (or clindamycin if beta-lactam intolerant), administered in relation to the HD procedure on: BSI and severe blood culture negative infection, during the first 6 months after initiation of hemodialysis with CVC as vascular access.
Secondary objectives 1
- To compare the bacterial genome from pathogens isolated from blood samples with the genome of pathogens in the patient’s own microbiota, in HD patients with BSI and CVC as vascular access.
Conditions and MedDRA coding
Blood poisoning in patients with renal failure treated with hemodialysis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 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))
Exclusion criteria 5
- Unable to give informed consent
- Known intolerance to beta-lactam antibiotics and clindamycin
- Active infection treated with antibiotics
- Pregnancy. In women of childbearing age, an approved birth control must be ensured
- Patients may be rescreened later i.e. within a time period of one month from start of HD, if exclusion criteria are reversible
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Hospitalization for BSI ≤ 6 months after randomization
- Hospitalization ≥ 3 days due to infection defined as: CRP ≥ 75 and negative blood cultures, treated with iv antibiotics, and occurring ≤ 6 months after randomization
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Clindamycin ”Alternova”, hårde kapsler
PRD454197 · Product
- Active substance
- Clindamycin
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 36 g gram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01FF01 — CLINDAMYCIN
- Marketing authorisation
- 37826
- MA holder
- ALTERNOVA A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Amoxicillin/clavulansyre ”Aurobindo”, filmovertrukne tabletter
PRD5416802 · Product
- Active substance
- Amoxicillin
- Substance synonyms
- AMOXICILLINE, AMOXICILLINUM
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 60 g gram(s)
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- J01CR02 — AMOXICILLIN AND ENZYME INHIBITOR
- Marketing authorisation
- 45148
- MA holder
- AUROBINDO PHARMA (MALTA) LIMITED
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Sjaelland
- Sponsor organisation
- Region Sjaelland
- Address
- Sygehusvej 10
- City
- Roskilde
- Postcode
- 4000
- Country
- Denmark
Scientific contact point
- Organisation
- Region Sjaelland
- Contact name
- Trial Manager, Niels Eske Bruun, Professor, DMSc, MD
Public contact point
- Organisation
- Region Sjaelland
- Contact name
- Trial Manager, Niels Eske Bruun, Professor, DMSc, MD
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 13 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 800 | 13 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-07-25 | 2024-07-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | protocol | 14 |
| Recruitment arrangements (for publication) | blank | 1 |
| Recruitment arrangements (for publication) | Statement financial and insurance and recruitment july 2024 | 2 |
| Subject information and informed consent form (for publication) | informed_concent_danish | 1 |
| Subject information and informed consent form (for publication) | subject_information | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Productresume Amoxicillin-clavulansyre Aurobindo Orifarm coated tablets 500mg 125mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Clindamycin Alternova hard capsules 150mg 300mg | 1 |
| Synopsis of the protocol (for publication) | Synopsis | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-06-25 | Denmark | Acceptable 2024-07-18
|
2024-07-25 |