Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty

NCT ID: NCT00423982

Last Updated: 2013-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2014-12-31

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.

Conditions

Prosthesis-related Infections; Staphylococcal Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rifampicin-combination therapy

Cloxacillin or vancomycin in combination with Rifampicin. Treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis.

Group Type: ACTIVE_COMPARATOR

Rifampin-combination therapy

Intervention Type: DRUG

Rifampin 300 mg x 3 po and cloxacillin 2 g x 4 iv for two weeks. Then rifampin 300 mg x 3 po and cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, rifampin 300 mg x 3 po and vancomycin 1 g x 2 iv for 6 weeks.

Monotherapy

Cloxacillin or vancomycin in the treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis.

Group Type: ACTIVE_COMPARATOR

Monotherapy

Intervention Type: DRUG

Cloxacillin 2 g x 4 iv for two weeks, then cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, vancomycin 1 g x 2 iv for 6 weeks.

Interventions

Rifampin-combination therapy

Rifampin 300 mg x 3 po and cloxacillin 2 g x 4 iv for two weeks. Then rifampin 300 mg x 3 po and cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, rifampin 300 mg x 3 po and vancomycin 1 g x 2 iv for 6 weeks.

Intervention Type: DRUG

Monotherapy

Cloxacillin 2 g x 4 iv for two weeks, then cloxacillin 1 g x 4 po for 4 weeks. In case of methicillin resistance, vancomycin 1 g x 2 iv for 6 weeks.

Intervention Type: DRUG

Other Intervention Names

Antimicrobial therapy in prosthetic joint infection.; Rifampicin and prosthetic joint infection.; Antimicrobial therapy in prosthetic joint infections.; Cloxacillin.; Vancomycin.

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oslo University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Finnur Snorrason, M.D, Ph.D

Role: STUDY_DIRECTOR

Ullevaal University Hospital

Locations

Buskerud Central Hospital

Drammen, , Norway

Elverum Hospital

Elverum, , Norway

Martina Hansen Hospital

Gjettum, , Norway

Ringerike Hospital

Hønefoss, , Norway

Lillehammer Hospital

Lillehammer, , Norway

Oslo University Hospital, Ulleval

Oslo, , Norway

Asker and Bærum Hospital

Rud, , Norway

St.Olav Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 32859235 (View on PubMed)

Other Identifiers

1603

Identifier Type: -

Identifier Source: org_study_id