Or v IV Antibiotics for Infection

NCT04723940 | Unknown Phase 3 FDA Drug

• 1 other identifier: JPAR 20D.1085
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

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.

Conditions

Joint Infection

Outcome Measures

Primary Outcomes (1)

• 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

  2 years

Study Arms (2)

Oral Antibiotics

ACTIVE COMPARATOR

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; Drug: Cefadroxil; Drug: Doxycycline Hcl; Drug: Clindamycin

Intravenous Antibiotics

ACTIVE COMPARATOR

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; Drug: Cefadroxil; Drug: Doxycycline Hcl; Drug: Clindamycin

Interventions

Bactrim DRUG

Bactrim will be given for 6 weeks to treat joint infection

Intravenous Antibiotics; Oral Antibiotics

Cefadroxil DRUG

Cefadroxil will be given for 6 weeks to treat joint infection

Intravenous Antibiotics; Oral Antibiotics

Doxycycline Hcl DRUG

Doxycycline HCl will given for 6 weeks to treat joint infection

Intravenous Antibiotics; Oral Antibiotics

Clindamycin DRUG

Clindamycin will given for 6 weeks to treat joint infection

Intravenous Antibiotics; Oral Antibiotics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Trimethoprim, Sulfamethoxazole Drug Combination; Cefadroxil; Clindamycin

Intervention Hierarchy (Ancestors)

Sulfamethoxazole; Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Sulfanilamides; Aniline Compounds; Amines; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Trimethoprim; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Cephalexin; Cephalosporins; beta-Lactams; Lactams; Thiazines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Lincomycin; Lincosamides; Pyrrolidines; Glycosides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2021
• First Posted: January 26, 2021
• Study Start: January 25, 2021
• Primary Completion: January 25, 2023
• Study Completion: January 25, 2023
• Last Updated: January 26, 2021

Record last verified: 2021-01

Locations

US (1)