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Or v IV Antibiotics for Infection

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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Joint Infection Drug: Bactrim Drug: Cefadroxil Drug: Doxycycline Hcl Drug: Clindamycin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Oral vs Intravenous Antibiotics for Treatment of Periprosthetic Joint Infection
Estimated Study Start Date : January 25, 2021
Estimated Primary Completion Date : January 25, 2023
Estimated Study Completion Date : January 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arms and Interventions
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Arm Intervention/treatment
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.
 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
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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

    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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04723940


Locations
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United States, Pennsylvania
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
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Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT04723940    
Other Study ID Numbers: JPAR 20D.1085
First Posted: January 26, 2021    Key Record Dates
Last Update Posted: January 26, 2021
Last Verified: January 2021

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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
Additional relevant MeSH terms:
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Infections
Communicable Diseases
Disease Attributes
Pathologic Processes
Doxycycline
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Trimethoprim, Sulfamethoxazole Drug Combination
Cefadroxil
 Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents