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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00423982
First received: January 17, 2007
Last updated: June 26, 2013
Last verified: June 2013
  Purpose

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 Intervention Phase
Prosthesis-related Infections
Staphylococcal Infections
Drug: Rifampin-combination therapy
Drug: Monotherapy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2006
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423982

Locations
Norway
Buskerud Central Hospital
Drammen, Norway, 3004
Elverum Hospital
Elverum, Norway, 2408
Martina Hansen Hospital
Gjettum, Norway, 1346
Ringerike Hospital
Hønefoss, Norway, 3504
Lillehammer Hospital
Lillehammer, Norway, 2609
Oslo University Hospital, Ulleval
Oslo, Norway, 0407
Asker and Bærum Hospital
Rud, Norway, 1309
St.Olav Hospital
Trondheim, Norway, 7030
Sponsors and Collaborators
Oslo University Hospital
Investigators
Study Director: Finnur Snorrason, M.D, Ph.D Ullevaal University Hospital
  More Information

No publications provided

Responsible Party: Oslo University Hospital
ClinicalTrials.gov Identifier: NCT00423982     History of Changes
Other Study ID Numbers: 1603
Study First Received: January 17, 2007
Last Updated: June 26, 2013
Health Authority: Norway: Norwegian Medicines Agency

Additional relevant MeSH terms:
Staphylococcal Infections
Prosthesis-Related Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Infection
Postoperative Complications
Pathologic Processes
Anti-Infective Agents
Cloxacillin
Rifampin
Vancomycin
Therapeutic Uses
Pharmacologic Actions
Anti-Bacterial Agents
Antibiotics, Antitubercular
Antitubercular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Leprostatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on August 19, 2014