Ignite Creation Date:
2024-05-05 @ 5:17 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00423982
Status:
UNKNOWN
Last Update Posted:
2013-06-27
First Post:
2007-01-17
Brief Title:
Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
Status:
UNKNOWN
Status Verified Date:
2013-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The number of patients requiring joint replacement is increasing due to its success in restoring function and pain relief and the growing population of the elderly One of the most serious complications of arthroplasty is joint prosthesis infection Due to the absence of prospective randomized controlled studies there is no consensus concerning diagnosis and treatment of prosthetic joint infections The main objective of this trial is to evaluate the clinical efficacy of rifampin combination therapy versus monotherapy using cloxacillin or vancomycin in early staphylococcal infections after total hip and knee arthroplasty
Detailed Description:
The study is a controlled randomized multicentre trial with 8 participating centres in Norway We will include patients with the diagnosis of early infections within 4 weeks post operativelyafter hip or knee replacement Patients with clinical signs of infection are scheduled for a standardized soft tissue revision Diagnosis of staphylococci must be established by arthrocentesis or at surgical revision and must grow in at least 28 culturesThe patients will randomly be assigned to antimicrobial therapy with or without rifampin by a randomization programme Antibiotics will be given for 6 weeks Two years follow-up The study end points are final follow-up visit after two years or relapse of infection
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None