Prosthesis-related InfectionsPhase 4NCT00423982
Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
A Phase 4 study testing Rifampin-combination therapy and Monotherapy in people with Prosthesis-related Infections and Staphylococcal Infections, run by Oslo University Hospital at 8 sites in Norway.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prosthesis-related Infections, Staphylococcal Infections
- What is being tested?
- Rifampin-combination therapy and Monotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 8 sitesNorway
- Study dates
- Apr 2006to Dec 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Norway8 sites
Buskerud Central Hospital
Drammen, 3004
Elverum Hospital
Elverum, 2408
Martina Hansen Hospital
Gjettum, 1346
Ringerike Hospital
Hønefoss, 3504
Lillehammer Hospital
Lillehammer, 2609
Oslo University Hospital, Ulleval
Oslo, 0407
Asker and Bærum Hospital
Rud, 1309
St.Olav Hospital
Trondheim, 7030
About this study
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.
Read the 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.
- Being tested
- Rifampin-combination therapy, Monotherapy
- Medical subject headings
- Prosthesis-Related Infections, Staphylococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifampin-combination therapyDrug
Also called Antimicrobial therapy in prosthetic joint infection., Rifampicin and prosthetic joint infection.
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.
MonotherapyDrug
Also called Antimicrobial therapy in prosthetic joint infections., Cloxacillin., Vancomycin.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2007 (estimated)
- Study startApr 2006
- Primary completionDec 2012
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prosthesis-related InfectionsStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Finnur Snorrason, M.D, Ph.D, Study director, Ullevaal University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00423982
- Sponsor's protocol ID
- 1603
- Status last verified
- Jun 2013
- First submitted
- 17 Jan 2007
- Last updated
- 27 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32859235
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT00423982
- Acronym / sponsor ID
- 1603
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rifampicin-combination therapy | Active comparator | Drug: Rifampin-combination therapyCloxacillin or vancomycin in combination with Rifampicin. Treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis. |
| Monotherapy | Active comparator | Drug: MonotherapyCloxacillin or vancomycin in the treatment of early staphylococcal prosthetic joint infections in addition to debridement and retention of the prosthesis. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rifampin-combination therapyAlso: Antimicrobial therapy in prosthetic joint infection., Rifampicin and prosthetic joint infection.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 | Rifampicin-combination therapy |
| MonotherapyAlso: Antimicrobial therapy in prosthetic joint infections., Cloxacillin., Vancomycin.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. | Drug | Monotherapy |
Primary outcome
Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2013.
- Derived from this study: PubMed 32859235Karlsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finnur Snorrason, M.D, Ph.D study director
Ullevaal University Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifampin-combination therapy and Monotherapy in people with Prosthesis-related Infections and Staphylococcal Infections, run by Oslo University Hospital at 8 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure defined as lack of clinical, biochemistry or radiological signs of infection at two years follow-up. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00423982, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2013.