Staphylococcal Infections Clinical Trial
Official title:
Rifampin Combination Therapy Versus Monotherapy in Early Staphylococcal Infections After Total Hip and Knee Arthroplasty
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.
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. ;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01447407 -
Effect of Adjuvant & Route of Administration on Safety & Immunogenicity of NDV-3 Vaccine
|
Phase 1 | |
| Recruiting |
NCT00518076 -
Staphylococcus Aureus Carriers Students Nursing Oxacillin Resistant
|
N/A | |
| Completed |
NCT01324440 -
Safety, Tolerability, and Immunogenicity of a Single Dose of Merck 0657nI Staphylococcus Aureus Vaccine With or Without Merck Aluminum Adjuvant (V710-002)
|
Phase 1 | |
| Completed |
NCT00501150 -
Oral Antibiotic Treatment at Home Instead of Intravenous Treatment in Hospital for Resistant Gram Positive Infections
|
N/A | |
| Completed |
NCT00071214 -
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
|
Phase 3 | |
| Completed |
NCT00063089 -
Safety and Behavior of S. Aureus Immune Globulin Intravenous(Human), [Altastaph] in Patients With S. Aureus Bacteremia and Continuing Fever
|
Phase 1/Phase 2 | |
| Completed |
NCT00175370 -
Vancomycin Study: Treatment of Catheter Related Bloodstream Infection Caused by Coagulase Negative Staphylococcus
|
N/A | |
| Recruiting |
NCT03456544 -
Vancomycin-Associated Acute Kidney Injury: A Cross-Sectional Study From a Multi- Center in China
|
||
| Completed |
NCT02557568 -
Evaluation of an Algorithm for Identifying Persistent Nasal Staphylococcus Aureus Carriage in a Cohort of Healthy Volunteers and Patients Regularly Monitored at the CHU of Saint-Etienne
|
N/A | |
| Terminated |
NCT01196169 -
Daptomycin Use for Antimicrobial Prophylaxis in Methicillin Resistant Staphylococcus Aureus (MRSA) Colonized Adult Patients Undergoing Primary Elective Hip, Knee, or Shoulder Arthroplasty
|
Phase 4 | |
| Completed |
NCT02640937 -
Biofilm Formation in Staphylococcus Epidermidis Associated Implant Infections
|
N/A | |
| Completed |
NCT01431326 -
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care
|
||
| Completed |
NCT02971657 -
Bacterial Phenotype of Staphylococcus Aureus Has no Effect on Patients` Clinical Outcome in Orthopedic Device Related Bone Infections
|
N/A | |
| Completed |
NCT00303069 -
V710 First-In-Man (FIM) Study (V710-001)
|
Phase 1 | |
| Completed |
NCT00156377 -
Prophylaxis With Intranasal Mupirocin for Prevention of S. Aureus Infections
|
Phase 4 | |
| Completed |
NCT00631566 -
Prospective Study of Methicillin-Resistant Staphylococcus Aureus (MRSA) Among HIV-Infected Persons
|
N/A | |
| Completed |
NCT00113191 -
Safety and Efficacy of Veronate® Versus Placebo in Preventing Nosocomial Staphylococcal Sepsis in Premature Infants
|
N/A | |
| Completed |
NCT02782078 -
Pharmacological Interaction of Rifampicin on Clindamycin in Staphylococcic Osteoarticular Infections
|
N/A | |
| Completed |
NCT00859677 -
Immunologic Predisposition of HIV Patients to Develop Methicillin-Resistant Staphylococcus Aureus (MRSA) Colonization and Infection
|
||
| Completed |
NCT00211900 -
Evaluation of Manufacturing Lot of StaphVAX
|
Phase 3 |