Ceftriaxone as Home IV for Staph Infections

Summary

Patients who are admitted to hospital with serious infections, such as those in bone, joints or spine, require a long course of intravenous (IV) antibiotics. After an initial treatment course in hospital or through a dedicated outpatient antibiotic program many patients can complete their treatment course at home. Such infections are often caused by bacteria called Staphylococci, and currently there are three antibiotic options used routinely. A fourth antibiotic, ceftriaxone, is a promising alternative; it is also effective against Staphylococci, and is more convenient, less costly and easier to give at home, however, it has not been studied thoroughly in a prospective manner. This study will compare ceftriaxone to routinely used antibiotics (cloxacillin, cefazolin or daptomycin) to see if ceftriaxone is equally as safe and efficacious in curing deep-seated Staphylococcal infections in patients receiving home IV antibiotics. Patients with deep-seated infections caused by methicillin-susceptible Staphylococcus aureus (MSSA) or coagulase-negative Staphylococcal species will be randomly assigned home IV treatment with ceftriaxone OR one of the three other antibiotics before leaving the hospital. Patients will then receive usual care from an Infectious Disease physician and Home IV team. The study team will assess whether cure has been achieved by the end of the IV treatment, follow-up at 6 months to see if patients remain infection-free, and record any side-effects of treatment. The overall goal is to determine whether ceftriaxone can be considered non-inferior to usual antibiotic treatment in treating Staphylococcal infections in a home IV setting.

Timeline

Start

2019-07-11

Primary completion

2023-07

Completion

2024-03-30

Publications

• Background Lother SA, Press N. Once-Daily Treatments for Methicillin-Susceptible Staphylococcus aureus Bacteremia: Are They Good Enough? Curr Infect Dis Rep. 2017 Sep 23;19(11):43. doi: 10.1007/s11908-017-0599-0.
• Background Hotchkies L, Grima DT, Hedayati S. The total process cost of parenteral antibiotic therapy: beyond drug acquisition cost. Clin Ther. 1996 Jul-Aug;18(4):716-25; discussion 702. doi: 10.1016/s0149-2918(96)80222-0.
• Background Patel UC, McKissic EL, Kasper D, Lentino JR, Pachucki CT, Lee T, Lopansri BK. Outcomes of ceftriaxone use compared to standard of therapy in methicillin susceptible staphylococcal aureus (MSSA) bloodstream infections. Int J Clin Pharm. 2014 Dec;36(6):1282-9. doi: 10.1007/s11096-014-9999-5. Epub 2014 Sep 4.
• Background Wieland BW, Marcantoni JR, Bommarito KM, Warren DK, Marschall J. A retrospective comparison of ceftriaxone versus oxacillin for osteoarticular infections due to methicillin-susceptible Staphylococcus aureus. Clin Infect Dis. 2012 Mar 1;54(5):585-90. doi: 10.1093/cid/cir857. Epub 2011 Dec 5.
• Background Winans SA, Luce AM, Hasbun R. Outpatient parenteral antimicrobial therapy for the treatment of methicillin-susceptible Staphylococcus aureus: a comparison of cefazolin and ceftriaxone. Infection. 2013 Aug;41(4):769-74. doi: 10.1007/s15010-013-0477-0. Epub 2013 May 19.

Drugs

Indications