Or v IV Antibiotics for Infection

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Rothman Institute Orthopaedics
Study ID
NCT04723940
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • Joint Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Bactrim — DRUG
    Bactrim will be given for 6 weeks to treat joint infection
  • Cefadroxil — DRUG
    Cefadroxil will be given for 6 weeks to treat joint infection
  • Doxycycline Hcl — DRUG
    Doxycycline HCl will given for 6 weeks to treat joint infection
  • Clindamycin — DRUG
    Clindamycin will given for 6 weeks to treat joint infection

Study Details

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.

Key Dates

First listed
Jan 26, 2021
Start date
Jan 25, 2021
Status verified
Oct 2026
Primary completion
Jan 25, 2028
Completion
Jan 25, 2028

Study Design

Enrollment
308 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.

Primary Outcome Measure

Rate of Postoperative Infections [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Rothman Orthopaedic InstitutePhiladelphiaPennsylvania19107-

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