ANTIBIOTIC EXPOSURE AT THE INFECTION SITE IN PERIPROSTHETIC JOINT INFECTIONS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20480

Enrollment

120

Registered

2021-04-27

Start date

2020-10-06

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthopedic infections

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: - Age = 18 years. - Written informed consent has been obtained from the patient - Suffering from periprosthetic (hip or knee) joint infections and therefore treated with one of the following antibiotics as part of the two-stage arthroplasty exchange: o IV: vancomycin, flucloxacillin or cefuroxime o Oral: flucloxacillin, clindamycin or co-trimoxazole - Patients undergoing a two-stage implant exchange of hip or knee with or without antibiotic free interval prior to re-implantation. - Able and willing to undergo joint punctures and venous blood sampling during and, in case of an antibiotic free interval, at the end of the six-weeks antibiotic treatment.

Exclusion criteria

Exclusion criteria: - Unable to draw samples for study purposes. - Language barriers. - The use of the target antibiotics at the start of study participation (and therefore at the start of the antibiotic treatment as part of the two-stage arthroplasty exchange). - The use of drugs interacting with the target antibiotics.

Design outcomes

Primary

Measure	Time frame
To develop a pharmacokinetic (PK) model for the relationship between dosage, blood concentration and infection site concentration, estimating covariates to determine differences in antibiotic concentrations in synovial fluid, synovial tissue and bone between different types of antibiotics and knee versus hip.	—

Secondary

Measure	Time frame
1. To develop and validate an analytical method for measuring antibiotic concentrations in synovial fluid, synovial tissue and bone tissue of the affected joint. 2. To determine the non-inferiority of oral antibiotics in comparison to intravenous antibiotics with regards to the antibiotic exposure at the site of infection. Antibiotic exposure is measured in antibiotic concentration related to the MIC of the bacteria targeted. 3. To determine the non-inferiority of oral antibiotics in comparison to intravenous antibiotics with regard to infection recurrence/success percentage and antibiotic-related side effects 4. To determine the added value for antimicrobial-loaded spacers, in relationship to the use of intravenous and oral antibiotics during the two-stage arthroplasty exchange.	—

Measure

Time frame

1. To develop and validate an analytical method for measuring antibiotic concentrations in synovial fluid, synovial tissue and bone tissue of the affected joint. 2. To determine the non-inferiority of oral antibiotics in comparison to intravenous antibiotics with regards to the antibiotic exposure at the site of infection. Antibiotic exposure is measured in antibiotic concentration related to the MIC of the bacteria targeted. 3. To determine the non-inferiority of oral antibiotics in comparison to intravenous antibiotics with regard to infection recurrence/success percentage and antibiotic-related side effects 4. To determine the added value for antimicrobial-loaded spacers, in relationship to the use of intravenous and oral antibiotics during the two-stage arthroplasty exchange.

—

Contacts

Public Contactbirgit koch

Erasmus MC, pharmacy

b.koch@erasmusmc.nl010-7033202

Outcome results