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

Staphylococcal Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00423982
• Other study ID #: 1603
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 17, 2007
• Last updated: June 26, 2013
• Start date: April 2006
• Est. completion date: December 2014

Study information

• Verified date: June 2013
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Prosthesis-Related Infections
• Staphylococcal Infections

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
Norway	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

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up.		2 years	No