Back to resultsOr v IV Antibiotics for Infection
Primary Purpose
Joint Infection
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bactrim
Cefadroxil
Doxycycline Hcl
Clindamycin
Sponsored by
About this trial
This is an interventional treatment trial for Joint Infection
Eligibility Criteria
Inclusion Criteria:
- aged ≥ 18 years
- willing and able to give informed consent
primary THA or TKA diagnosed with PJI based on International Consensus Meeting criteria
- A sinus communicating with the prosthesis OR
- Two positive cultures obtained from the prosthesis OR
- 3 of 5 criteria:
- Elevated ESR (>30mm/hr) and CRP (>10mg/L)
- Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip
- Elevated synovial neutrophil percentage (>80%)
- One positive culture
- Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400)
- PJI treated by debridement and implant retention, or excision of the prosthetic joint (with or without planned reimplantation)
- received ≤ 7 days of IV therapy after an appropriate surgical intervention
Exclusion Criteria:
- Previously treated for native septic arthritis or PJI in the same joint
- S. aureus bacteremia on presentation or within the previous month
- clinical, histological or microbiological evidence of mycobacterial, fungal or parasitic etiology of the infection
- any other concomitant infection that, in the opinion of the clinician responsible for the patient, requires a prolonged course of IV antibiotic therapy (e.g. bacterial endocarditis, mediastinal infection, central nervous system infection)
- septic shock or systemic features that, in the opinion of the clinician responsible for the patient, requires a course of IV antibiotic therapy (the patient could be re-evaluated if these features resolved)
- an infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (e.g. when organisms are only sensitive to IV antibiotics or PO antibiotics)
- unlikely to comply with trial requirements following randomization in the opinion of the investigator
Sites / Locations
- Rothman Orthopaedic Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oral Antibiotics
Intravenous Antibiotics
Arm Description
Participant will receive 6 weeks of oral antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
Participant will receive 6 weeks of intravenous (IV) antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
Outcomes
Primary Outcome Measures
Rate of Postoperative Infections
The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics versus those treated with intravenous antibiotics
Secondary Outcome Measures
Full Information
NCT ID
NCT04723940
First Posted
January 22, 2021
Last Updated
January 22, 2021
Sponsor
Rothman Institute Orthopaedics
1. Study Identification
Unique Protocol Identification Number
NCT04723940
Brief Title
Or v IV Antibiotics for Infection
Official Title
Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 25, 2021 (Anticipated)
Primary Completion Date
January 25, 2023 (Anticipated)
Study Completion Date
January 25, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rothman Institute Orthopaedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
Brief Summary
Management of periprosthetic joint infection (PJI) commonly includes 6 weeks of intravenous (IV) antibiotics after surgical treatment. However, there is little evidence to suggest that oral (PO) therapy results in worse outcomes. This study aims to determine whether or not PO antibiotics are non-inferior to IV antibiotics in treating PJI. The study is a multicenter, parallel-group, randomized (1 : 1), open-label, non-inferiority trial. The non-inferiority margin will be set at 10%. Adults with a clinical diagnosis of PJI according to the International Consensus Meeting (ICM) criteria who would ordinarily receive at least 6 weeks of antibiotics and have received ≤ 7 days of IV therapy from surgery will be included. A total of 308 participants will be centrally computer-randomized to PO or IV antibiotics to complete the first 6 weeks of therapy. Follow-on PO therapy will be permitted in either arm. The primary outcome is the proportion of participants experiencing treatment failure within 1 year. An associated cost-effectiveness evaluation including complications, resource utilization and quality-of-life data will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Joint Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
308 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral Antibiotics
Arm Type
Active Comparator
Arm Description
Participant will receive 6 weeks of oral antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
Arm Title
Intravenous Antibiotics
Arm Type
Active Comparator
Arm Description
Participant will receive 6 weeks of intravenous (IV) antibiotic therapy to treat their infection. The type of antibiotic given will be at the discretion of the infectious disease doctor.
Intervention Type
Drug
Intervention Name(s)
Bactrim
Intervention Description
Bactrim will be given for 6 weeks to treat joint infection
Intervention Type
Drug
Intervention Name(s)
Cefadroxil
Intervention Description
Cefadroxil will be given for 6 weeks to treat joint infection
Intervention Type
Drug
Intervention Name(s)
Doxycycline Hcl
Intervention Description
Doxycycline HCl will given for 6 weeks to treat joint infection
Intervention Type
Drug
Intervention Name(s)
Clindamycin
Intervention Description
Clindamycin will given for 6 weeks to treat joint infection
Primary Outcome Measure Information:
Title
Rate of Postoperative Infections
Description
The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics versus those treated with intravenous antibiotics
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
aged ≥ 18 years
willing and able to give informed consent
primary THA or TKA diagnosed with PJI based on International Consensus Meeting criteria
A sinus communicating with the prosthesis OR
Two positive cultures obtained from the prosthesis OR
3 of 5 criteria:
Elevated ESR (>30mm/hr) and CRP (>10mg/L)
Elevated synovial leukocyte count (>3000 cells/µL) or change of ++ on leukocyte esterase strip
Elevated synovial neutrophil percentage (>80%)
One positive culture
Positive histological analysis of periprosthetic tissue (>5 neutrophils per high power field in 5 high power fields x400)
PJI treated by debridement and implant retention, or excision of the prosthetic joint (with or without planned reimplantation)
received ≤ 7 days of IV therapy after an appropriate surgical intervention
Exclusion Criteria:
Previously treated for native septic arthritis or PJI in the same joint
S. aureus bacteremia on presentation or within the previous month
clinical, histological or microbiological evidence of mycobacterial, fungal or parasitic etiology of the infection
any other concomitant infection that, in the opinion of the clinician responsible for the patient, requires a prolonged course of IV antibiotic therapy (e.g. bacterial endocarditis, mediastinal infection, central nervous system infection)
septic shock or systemic features that, in the opinion of the clinician responsible for the patient, requires a course of IV antibiotic therapy (the patient could be re-evaluated if these features resolved)
an infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (e.g. when organisms are only sensitive to IV antibiotics or PO antibiotics)
unlikely to comply with trial requirements following randomization in the opinion of the investigator
Facility Information:
Facility Name
Rothman Orthopaedic Institute
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
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