- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01760863
Oral Antibiotics After 2-Stage Revision for Infected Total Hip Arthroplasty and Total Knee Arthroplasty
The Utility of Oral Antibiotic Therapy Following 2-stage Revision Arthroplasty for Infected Prosthetic Hips and Knees
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60607
- Rush University Medical Center
-
Winfield, Illinois, United States, 60190
- Central DuPage Hospital
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19107
- Rothman Institute
-
-
Tennessee
-
Nashville, Tennessee, United States, 37232
- Vanderbilt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion criteria:
Adult patients undergoing 2-stage revision arthroplasty of the knee or hip with the causative organism(s) identified using tissue culture and/or joint fluid analysis that is amenable to oral antibiotic therapy. Patients must be able to tolerate oral antibiotics and agree to participate in the study.
Exclusion criteria:
Patients with a fungal prosthetic joint infection, unable to tolerate or refuse to undergo oral antibiotic therapy, unable to follow-up at the specified intervals, allergic to the therapy of preference, or have an organism that is not amenable to oral antibiotic therapy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Oral Antibiotics
Oral antibiotics for 3 months; recommendation for antibiotics will be made by an infectious disease specialist.
|
Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.
|
No Intervention: No oral antibiotics
No oral antibiotics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Infection Rate
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11040802
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prosthesis-Related Infections
-
BioMed Valley Discoveries, IncCompleted
-
Tourcoing HospitalCompletedProsthesis-related InfectionsFrance
-
University Hospital, ToursCompletedProsthesis-related InfectionsFrance
-
Pro-Implant FoundationCharite University, Berlin, GermanyUnknownProsthesis-related InfectionsGermany
-
The Cleveland Clinic3MCompletedJoint Diseases | Musculoskeletal Diseases | Prosthesis-related Infections | Wound ComplicationsUnited States
-
Oslo University HospitalUnknownStaphylococcal Infections | Prosthesis-related InfectionsNorway
-
University Hospital, Strasbourg, FranceRecruitingProsthesis Related InfectionFrance
-
University of Sao PauloFundação de Amparo à Pesquisa do Estado de São PauloCompletedProstheses-related Infections
-
University Hospital of FerraraCompletedDevice Related Infection
-
Tourcoing HospitalCompletedProsthesis-Related InfectionsFrance
Clinical Trials on Oral Antibiotics
-
University Hospital, Basel, SwitzerlandCompletedInfectious Diseases and ManifestationsSwitzerland
-
Columbia UniversityActive, not recruitingSepsis | Critical Illness | Nutrition Disorders | Antibiotic Resistant Infection | Nosocomial Infection | Pathogen TransmissionUnited States
-
Johns Hopkins UniversityPatient-Centered Outcomes Research InstituteNot yet recruitingGram-negative Bacteremia
-
Henrik NielsenRecruitingBrain Abscess | Cerebral AbscessDenmark
-
Rigshospitalet, DenmarkCompleted
-
Major Extremity Trauma Research ConsortiumUnited States Department of DefenseNot yet recruitingInfections | Amputation | Nonunion of Fracture | Antibiotic Side Effect | Fracture | Lower Extremity Fracture | Infected Wound | Injury Leg | Internal Fixation; Complications, Infection or Inflammation
-
Prisma Health-UpstateTerminated
-
Woman'sRecruitingPreterm Birth | Preterm Labor | Rupture of Membranes; Premature | Rupture of Membranes; Delayed Delivery (Following Spontaneous Rupture) | Rupture of Membranes; Premature, Affecting Fetus | Preterm PROM (Pregnancy)United States
-
University of Colorado, DenverWithdrawn
-
Helsinki University Central HospitalActive, not recruitingColorectal Neoplasms | Colorectal Cancer | Surgery--Complications | Surgical Site Infection | Colorectal Carcinoma | Rectal Adenocarcinoma | Rectum Neoplasm | Rectum CarcinomaFinland