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

NCT00423982 | Unknown Phase 4 DMC

• 1 other identifier: 1603
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

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.

Conditions

Prosthesis-related Infections; Staphylococcal Infections

Outcome Measures

Primary Outcomes (1)

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

  2 years

Study Arms (2)

Rifampicin-combination therapy

ACTIVE COMPARATOR

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

Monotherapy

ACTIVE COMPARATOR

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

Drug: Monotherapy

Interventions

Rifampin-combination therapy 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.

Also known as: Antimicrobial therapy in prosthetic joint infection., Rifampicin and prosthetic joint infection.

Rifampicin-combination therapy

Monotherapy 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.

Also known as: Antimicrobial therapy in prosthetic joint infections., Cloxacillin., Vancomycin.

Monotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (8)

Buskerud Central Hospital

Drammen, 3004, Norway

Location

Elverum Hospital

Elverum, 2408, Norway

Location

Martina Hansen Hospital

Gjettum, 1346, Norway

Location

Ringerike Hospital

Hønefoss, 3504, Norway

Location

Lillehammer Hospital

Lillehammer, 2609, Norway

Location

Oslo University Hospital, Ulleval

Oslo, 0407, Norway

Location

Asker and Bærum Hospital

Rud, 1309, Norway

Location

St.Olav Hospital

Trondheim, 7030, Norway

Location

Related Publications (1)

• 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.

  PMID: 32859235 DERIVED

MeSH Terms

Conditions

Prosthesis-Related Infections; Staphylococcal Infections

Interventions

Rifampin; Cloxacillin; Vancomycin

Condition Hierarchy (Ancestors)

Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Oxacillin; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Finnur Snorrason, M.D, Ph.D

  Ullevaal University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2007
• First Posted: January 18, 2007
• Study Start: April 1, 2006
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2014
• Last Updated: June 27, 2013

Record last verified: 2013-06

Locations

NO (8)