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

NCT00423982 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2013-06-27

No results posted yet for this study

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.

Conditions

  • Prosthesis-related Infections
  • Staphylococcal Infections

Interventions

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.

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.

Sponsors & Collaborators

  • Oslo University Hospital

    lead OTHER

Principal Investigators

  • Finnur Snorrason, M.D, Ph.D · Ullevaal University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-04-30
Primary Completion
2012-12-31
Completion
2014-12-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00423982 on ClinicalTrials.gov