Clinical trial NCT00423982: Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
Official title: Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Prosthesis-related Infections
Staphylococcal Infections
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2007-01-18
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 operatively)after 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 2/8 cultures.The 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.

Eligibility criteria: Inclusion Criteria:

* Prosthetic joint infections category 2 or 3 (early post.op infections within 4 weeks).
* Diagnosis of staphylococci.
* Clinically and radiographically stable implants kept in place after revision.

Exclusion Criteria:

* Infection with other microorganisms than staphylococci.
* Less than 2 years of expected survival.
* Predictable inability to comply with the treatment and/or follow-up visits.
* Contraindication to the use of study medication including acute or chronic liver disease.
* Lack of written consent.
* Fertile women.
* Patients taking less than 80% of the study medication.

Primary outcomes:
measure: Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Drammen
country: Norway
facility: Buskerud Central Hospital
city: Elverum
country: Norway
facility: Elverum Hospital
city: Gjettum
country: Norway
facility: Martina Hansen Hospital
city: Hønefoss
country: Norway
facility: Ringerike Hospital
city: Lillehammer
country: Norway
facility: Lillehammer Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital, Ulleval
city: Rud
country: Norway
facility: Asker and Bærum Hospital
city: Trondheim
country: Norway
facility: St.Olav Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Finnur Snorrason, M.D, Ph.D
role: STUDY_DIRECTOR
References:
citation: Karlsen OE, Borgen P, Bragnes B, Figved W, Grogaard B, Rydinge J, Sandberg L, Snorrason F, Wangen H, Witsoe E, Westberg M. Rifampin combination therapy in staphylococcal prosthetic joint infections: a randomized controlled trial. J Orthop Surg Res. 2020 Aug 28;15(1):365. doi: 10.1186/s13018-020-01877-2.