Clinical trial • Phase IV • Infectious Disease

Amoxicillin; Clavulanic acid for Bloodstream infection (bacteraemia/sepsis) | End-stage kidney disease

Phase IV trial of Amoxicillin; Clavulanic acid for Bloodstream infection (bacteraemia/sepsis) | End-stage kidney disease.

Overview

Trial Therapeutic Area
Infectious Disease
Trial Disease
Bloodstream infection (bacteraemia/sepsis) | End-stage kidney disease
Trial Stage
Phase IV
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
25-06-2024
First CTIS Authorization Date
25-07-2024

Trial design

Randomised, placebo-controlled trial. active intervention: amoxicillin/clavulanic acid administered in relation to the hemodialysis procedure; clindamycin as an alternative if beta-lactam intolerant. doses/schedule not specified in the ctis record. Phase IV trial across 13 sites in Denmark.

Randomised
Yes
Comparator
Placebo-controlled trial. Active intervention: amoxicillin/clavulanic acid administered in relation to the hemodialysis procedure; clindamycin as an alternative if beta-lactam intolerant. Doses/schedule not specified in the CTIS record.
Target Sample Size
800
Trial Duration For Participant
180

Eligibility

Recruits 800 Vulnerable population not selected in population settings. 'Unable to give informed consent' is listed as an exclusion criterion; informed consent from participants is required. No assent or minor consent procedures are described..

Pregnancy Exclusion
Pregnancy. In women of childbearing age, an approved birth control must be ensured
Vulnerable Population
Vulnerable population not selected in population settings. 'Unable to give informed consent' is listed as an exclusion criterion; informed consent from participants is required. No assent or minor consent procedures are described.

Inclusion criteria

  • {"criterion_text":"- 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

  • {"criterion_text":"- Unable to give informed consent"}
  • {"criterion_text":"- Known intolerance to beta-lactam antibiotics and clindamycin"}
  • {"criterion_text":"- Active infection treated with antibiotics"}
  • {"criterion_text":"- Pregnancy. In women of childbearing age, an approved birth control must be ensured"}
  • {"criterion_text":"- 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 endpoints

  • {"endpoint_text":"- Hospitalization for BSI ≤ 6 months after randomization","definition_or_measurement_approach":"Occurrence of hospitalization for bloodstream infection (BSI) within 6 months after randomization (as stated)."}
  • {"endpoint_text":"- Hospitalization ≥ 3 days due to infection defined as: CRP ≥ 75 and negative blood cultures, treated with iv antibiotics, and occurring ≤ 6 months after randomization","definition_or_measurement_approach":"Hospitalization of at least 3 days due to infection meeting the definition: CRP ≥ 75, negative blood cultures, treated with IV antibiotics, occurring within 6 months after randomization."}

Recruitment

Planned Sample Size
800
Recruitment Window Months
87
Consent Approach
Informed consent is required; 'Unable to give informed consent' is an exclusion. Subject information and informed consent forms are available (documents listed), including an informed consent form in Danish. No description of assent or age-specific consent documents is provided.

Geography

Total Number Of Sites
13
Total Number Of Participants
800

Denmark

Earliest CTIS Part Ii Submission Date
12-07-2024
Latest Decision Or Authorization Date
25-07-2024
Processing Time Days
13
Number Of Sites
13
Number Of Participants
800

Sites

Site Name
Region Hovedstaden
Department Name
Nyremedicinsk afdeling
Contact Person Name
Henrik Post Hansen
Contact Person Email
Henrik.Post.Hansen@regionh.dk
Site Name
Rigshospitalet
Department Name
Nyremedicinsk afdeling
Contact Person Name
Marianne Rix
Contact Person Email
Marianne.Rix@regionh.dk
Site Name
Region Syddanmark
Department Name
Nyremedicinsk Afdeling
Contact Person Name
Jan Dominik Kampmann
Contact Person Email
JDK@rsyd.dk
Site Name
Region Sjaelland
Department Name
Nyremedicinsk afdeling
Contact Person Name
Velena Popovic
Contact Person Email
vep@regionsjaelland.dk
Site Name
Region Hovedstaden
Department Name
Nyremedicinsk afdeling, Nordsjællands Hospital Hillerød
Contact Person Name
Marianne Camilla Bertelsen
Site Name
Region Syddanmark
Department Name
Nyremedicinsk afdeling (Regionshospitalet Esbjerg Finsensgade 35 6700 Esbjerg)
Contact Person Name
Majbritt Grønborg Knudsen
Site Name
Region Midtjylland
Department Name
Nyremedicinsk afdeling
Contact Person Name
Else Randers
Contact Person Email
Else.Randers@rm.dk
Site Name
Region Syddanmark
Department Name
Nyremedicinsk Afdeling
Contact Person Name
Per Bruno Jensen
Contact Person Email
Per.Bruno.Jensen@rsyd.dk
Site Name
Region Midtjylland
Department Name
Nyremedicinsk afdeling, Gødstrup
Contact Person Name
Frank Holden Mose
Site Name
Region Syddanmark
Department Name
Nyremedicinsk afdeling, Sygehus Lillebælt, Kolding
Contact Person Name
Anne Daugaard Thuesen0
Contact Person Email
Anne.Daugaard.Thuesen2@rsyd.dk
Site Name
Region Sjaelland
Department Name
Nyremedicinsk Afdeling
Contact Person Name
Rikke Borg
Contact Person Email
rbor@regionsjaelland.dk
Site Name
Region Nordjylland
Department Name
Nyremedicinsk Afdeling
Contact Person Name
Jesper Mosgaard Rantanen
Contact Person Email
jemr@rn.dk
Site Name
Region Midtjylland
Department Name
Nyremedicinsk afdeling
Contact Person Name
Krista Dybtved Kjaergaard
Contact Person Email
Krista.Kjaergaard@rm.dk

Sponsor

Primary sponsor

Full Name
Region Sjaelland
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
Denmark

Third parties

  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
Amoxicillin/clavulansyre ”Aurobindo”, filmovertrukne tabletter
Active Substance
Amoxicillin; Clavulanic acid
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
500 mg (max daily dose amount as listed in product data)
Investigational Product Name
Clindamycin ”Alternova”, hårde kapsler
Active Substance
Clindamycin
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Authorised
Maximum Dose
300 mg (max daily dose amount as listed in product data)
Combination Treatment
Yes

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