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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- aged ≥ 18 years
- willing and able to give informed consent
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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

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
United States, Pennsylvania | |
Rothman Orthopaedic Institute | |
Philadelphia, Pennsylvania, United States, 19107 |
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 |
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 |
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 |