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Or v IV Antibiotics for Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04723940
Recruitment Status : Enrolling by invitation
First Posted : January 26, 2021
Last Update Posted : January 26, 2021
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Tracking Information
First Submitted Date  ICMJE January 22, 2021
First Posted Date  ICMJE January 26, 2021
Last Update Posted Date January 26, 2021
Estimated Study Start Date  ICMJE January 25, 2021
Estimated Primary Completion Date January 25, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2021)
Rate of Postoperative Infections [ Time Frame: 2 years ]
The investigator will measure the incidence of postoperative infections in participants treated with oral antibiotics versus those treated with intravenous antibiotics
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Or v IV Antibiotics for Infection
Official Title  ICMJE Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Joint Infection
Intervention  ICMJE
  • Drug: Bactrim
    Bactrim will be given for 6 weeks to treat joint infection
  • Drug: Cefadroxil
    Cefadroxil will be given for 6 weeks to treat joint infection
  • Drug: Doxycycline Hcl
    Doxycycline HCl will given for 6 weeks to treat joint infection
  • Drug: Clindamycin
    Clindamycin will given for 6 weeks to treat joint infection
Study Arms  ICMJE
  • Active Comparator: Oral Antibiotics
    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.
    Interventions:
    • Drug: Bactrim
    • Drug: Cefadroxil
    • Drug: Doxycycline Hcl
    • Drug: Clindamycin
  • Active Comparator: Intravenous Antibiotics
    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.
    Interventions:
    • Drug: Bactrim
    • Drug: Cefadroxil
    • Drug: Doxycycline Hcl
    • Drug: Clindamycin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: January 22, 2021)
308
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 25, 2023
Estimated Primary Completion Date January 25, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

    1. A sinus communicating with the prosthesis OR
    2. Two positive cultures obtained from the prosthesis OR
    3. 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04723940
Other Study ID Numbers  ICMJE JPAR 20D.1085
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Rothman Institute Orthopaedics
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Rothman Institute Orthopaedics
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Rothman Institute Orthopaedics
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP