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

Sponsor

Oslo University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT00423982

Collaborator

(none)

100

Enrollment

Locations

Arms

104

Duration (Months)

12.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prosthesis-related Infections Staphylococcal Infections	Drug: Rifampin-combination therapy Drug: Monotherapy	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	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. Other Names: Antimicrobial therapy in prosthetic joint infection. Rifampicin and prosthetic joint infection.
Active Comparator: Monotherapy Cloxacillin or vancomycin in the treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis.	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. Other Names: Antimicrobial therapy in prosthetic joint infections. Cloxacillin. Vancomycin.

Arm

Intervention/Treatment

Active Comparator: 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.

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.

Other Names:

Antimicrobial therapy in prosthetic joint infection.

Rifampicin and prosthetic joint infection.

Active Comparator: Monotherapy

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

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.

Other Names:

Antimicrobial therapy in prosthetic joint infections.

Cloxacillin.

Vancomycin.

Outcome Measures

Primary Outcome Measures

Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up. [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Buskerud Central Hospital	Drammen	Norway	3004
2	Elverum Hospital	Elverum	Norway	2408
3	Martina Hansen Hospital	Gjettum	Norway	1346
4	Ringerike Hospital	Hønefoss	Norway	3504
5	Lillehammer Hospital	Lillehammer	Norway	2609
6	Oslo University Hospital, Ulleval	Oslo	Norway	0407
7	Asker and Bærum Hospital	Rud	Norway	1309
8	St.Olav Hospital	Trondheim	Norway	7030