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Apr '23 Infectious Disease Update

Posted by Doug Black, PharmD., Ann Lloyd, PharmD on Apr 11th 2023

Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board and Antimicrobial Stewardship Program Manager. Links marked with a * are available to Sanford Guide with Stewardship Assist, Sanford Guide Web Edition, and Sanford Guide All Access clients. All other links are available without a Sanford Guide subscription. To sign up for ID updates to your inbox, register here. 

April 2023

Sanford Guide Updates

SARS-CoV-2 / COVID-19

  • Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
  • April 4: The US FDA issues an emergency use authorization (EUA) for the use of vilobelimab injection for the treatment of COVID-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or ECMO. Vilobelimab is an anti-C5a monoclonal antibody. Recommended dosage: 800 mg IV within 48 hours of intubation (day 1) followed by administration on days 2, 4, 8, 15 and 22 as long as the patient is hospitalized (even if discharged from ICU). Press release here. Fact sheet for healthcare providers here.
  • COVID-19 vaccination in cancer patients: recommendations from NCCN here.
  • Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
  • ESCMID COVID-19 living guidelines: drug treatment and clinical management (Clin Microbiol Infect 2022;28:222). Available at PMC.
  • Guidelines on COVID-19 diagnosis, serology, treatment and management, and infection prevention: IDSA and NIH.
  • Living WHO guideline on drugs for COVID-19 (BMJ 2021;375:n2936).
  • Living WHO guideline on drugs to prevent COVID-19 (BMJ 2021;372:n526). Available here.
  • Living WHO guideline on prophylaxis against COVID-19 (BMJ 2021;373:n949). Available at PMC.
  • Management of hospitalized adults with COVID-19: a European Respiratory Society living guideline (Eur Respir J 2021;57(4):2100048). Available at PMC.

OTC Naloxone Nasal Spray Approved

  • On March 29, the US FDA approved naloxone HCl 4 mg nasal spray (Narcan) for over-the-counter (OTC) use. The timeline for availability and price will be determined by the manufacturer. The FDA will work with stakeholders to help facilitate the continued availability of naloxone nasal spray products during implementation of the switch from prescription to OTC status, which may take months. Other formulations and dosages of naloxone will remain available by prescription only. Click here for full news release.

Rezafungin Approved

  • Rezafungin* (tradename Rezzayo) has been approved for use in patients ≥18 years of age who have limited or no alternative options for the treatment of candidemia and invasive candidiasis. Approval is based on limited clinical safety and efficacy data. The recommended dosage is an initial 400 mg IV loading dose, followed by 200 mg IV once weekly. Safety has not been established beyond four weekly doses.

Vaccine Updates

  • Cholera Vaccine, Live, Oral (Vaxchora*) has been unavailable in the US since December 2020. According to the manufacturer, resupply is scheduled for early May 2023.
  • The US FDA has approved the IM route of administration for M-M-R II (measles, mumps, and rubella virus vaccine), Varivax* (varicella virus vaccine, live attenuated), and ProQuad (measles, mumps, rubella, and varicella virus vaccine) in addition to the previous subcutaneous-only route of administration. This allows all routine childhood vaccines to be administered by the same IM route, reducing complexity. Press release here.

Malaria Detection by RDT

  • Rapid diagnostic tests (RDT) play an important role in malaria case management. The BinaxNOW Malaria test uses monoclonal antibodies to target the histidine-rich protein-2 (HRP2) antigen specific to Plasmodium falciparum and a pan-malarial antigen common to all four species of Plasmodium capable of infecting humans. A negative RDT no longer reliably rules out P. falciparum due to the increasing global prevalence of HRP2/3 deletion mutants. A negative RDT should be quickly followed by a malaria blood film (Malaria J 2022;21:26).

Antimicrobial Stewardship Pearl

Intravenous to oral switch as an antimicrobial stewardship intervention

  • A recent study provides more evidence to support antimicrobial stewardship efforts related to intravenous (IV) to oral (PO) conversion in patients with community-acquired pneumonia (CAP). This retrospective, cohort study describes IV to PO conversion practices and evaluates clinical outcomes among adult patients admitted with CAP from more than 600 hospitals in the United States. Of the patients included in the study, 30.7% (116,118) were switched to oral therapy before discharge including 5.8% switched by day 3 (early switchers). Early switching was associated with shorter length of stay, fewer days on IV antibiotics, and shorter total antibiotic duration without worsening outcomes. 
  • This large study adds to the evidence to support the safety of early switch to oral therapy for patients with CAP. However, there was a low rate of early switching in the study and most patients received IV therapy throughout the hospital stay. Antimicrobial stewardship programs can use the findings from this study, along with recommendations from the Centers for Disease Control and Prevention Core Elements of Hospital Antibiotic Stewardship Programs and the Infectious Diseases Society of America/Society for Healthcare Epidemiology of America Implementation Guidelines for Antibiotic Stewardship Programs to encourage prescribers to use an early switch to oral therapy in clinically stable patients to help reduce cost and length of stay.  Clin Infect Dis 2023;ciad196 

Drug Shortages (US)

  • Antimicrobial drugs or vaccines in reduced supply or unavailable (as of April 8, 2023) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • New shortages since March 10, 2023:
      • Penicillin G benzathine/Penicillin G procaine (Bicillin)
      • Polymyxin B sulfate/Trimethoprim sulfate ophthalmic solution
    • Shortage recently resolved:
      • Ampicillin-sulbactam injection
      • Ciprofloxacin 0.3% ophthalmic solution
    • Antibacterial drugs:
      • Aminoglycosides:
        • Amikacin injection
        • Gentamicin injection
        • Neomycin tablets
        • Tobramycin injection
      • Bacitracin ophthalmic ointment (unavailable)
      • Carbapenems:
        • Meropenem injection
      • Cephalosporins:
        • Cefazolin injection
        • Cefixime 400 mg capsules
        • Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success. Click here for details),
      • Clindamycin injection
      • Doxycycline oral suspension
      • Fluoroquinolones:
        • Ciprofloxacin injection
        • Ciprofloxacin 0.3% ophthalmic solution
        • Ofloxacin 0.3% ophthalmic solution
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection
      • Macrolides/azalides:
        • Azithromycin injection
        • Azithromycin ophthalmic solution 1% (unavailable)
        • Erythromycin 0.5% ophthalmic ointment
      • Metronidazole injection
      • Nitrofurantoin oral suspension
      • Penicillins:
        • Amoxicillin (all oral formulations)
        • Amoxicillin-clavulanate (all oral formulations)
        • Dicloxacillin capsules (250 mg, 500 mg)
        • Penicillin G benzathine injection
        • Piperacillin-tazobactam injection
      • Rifaximin 200 mg tablets
      • Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable)
      • Sulfanilamide 15% vaginal cream (unavailable)
    • Antifungal drugs: 
      • Amphotericin B injection
      • Amphotericin B Lipid Complex (ABLC)
      • Clotrimazole 10 mg oral troches
    • Antimycobacterial drugs: 
      • Isoniazid 300 mg tablets
      • Rifampin capsules
      • Rifampin injection
      • Rifapentine 150 mg tablets
    • Antiparasitic drugs:
      • Primaquine
    • Antiviral drugs: 
      • Oseltamivir capsules
      • Oseltamivir powder for oral suspension
      • Valganciclovir tablets
      • Valganciclovir powder for oral solution
    • Vaccines:
      • None
  • Antimicrobial drugs recently discontinued: 
    • Ritonavir oral solution 80 mg/mL (January 2023)
    • Lindane 1% shampoo (discontinued by Wockhardt USA in June 2022, no other supplier)
    • Quinupristin-Dalfopristin (discontinued by Pfizer in early 2022, no other supplier)
    • Gemifloxacin 320 mg tablet (August 2022, no further US distribution)
    • Gentamicin sulfate 0.3% ophthalmic ointment (July 2022)
    • Mupirocin calcium 2% cream (Bactroban [GSK], June 2020)
    • Bacitracin injection (February 2020)
    • Interferon alfa-2b (Intron A, October 2019)
    • Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], August 2019)
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