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September '25 Infectious Diseases Update

Posted by Doug Black, PharmD., Ann Lloyd, PharmD. on Sep 10th 2025

SEPTEMBER 2025

Article of the Month (Editors' Choice)

Dalbavancin for Treatment of Staphylococcus aureus Bacteremia: The DOTS Randomized Clinical Trial

By Henry F. Chambers, MD, and Douglas J. Black, PharmD

  • Treatment of complicated S. aureus bacteremia (SAB) generally requires 4-6 weeks of IV antibiotics. Dalbavancin*, a lipoglycopeptide with a long terminal half-life and potent antistaphylococcal activity (including MRSA), may be an effective treatment option that does not require long-term IV access. Published experience so far is limited and conflicting.
  • Dalbavancin as an Option for Treatment of Staphylococcus aureus Bacteremia (DOTS) (JAMA 2025 Aug 13:e2512543 [online ahead of print]) was an open-label, assessor-masked, randomized, superiority trial conducted at 23 US and Canadian medical centers.
  • Hospitalized adult patients with complicated SAB who achieved blood culture clearance (defined as no growth after a 48 hour incubation) after at least 72 hours (but not more than 10 days) of initial IV antibiotic therapy were eligible.
  • Key exclusions included patients with CNS infection, retained infected prosthetic material, left-sided endocarditis, and severe immunocompromise.
  • 200 eligible patients were randomized to receive either two doses of dalbavancin (n=100; 1500 mg IV on days 1 and 8) or 4-8 weeks of standard IV therapy (n=100). Standard therapy was a single agent: cefazolin or antistaphylococcal penicillin for MSSA, vancomycin or daptomycin for MRSA.
  • Primary outcome: Desirability of Outcome Ranking (DOOR) at day 70 after randomization. The DOOR endpoint consists of 5 components: clinical success, infectious complications, safety complications, mortality, and health-related quality of life, with a score of 1 being the best (alive, clinical success, no complications) and 5 being the worst (death).
  • Secondary outcomes: clinical efficacy (composite of the lack of clinical failure, infectious complications, or mortality) and safety (incidence of serious adverse events or adverse events leading to discontinuation of study drug).
  • The study was powered to evaluate superiority by DOOR. Superiority could be concluded if the 95% CI for the probability of dalbavancin having a superior DOOR was >50%. A 20% noninferiority margin was selected for the secondary clinical efficacy outcome, based on clinician survey data and previous trials.
  • Results:
    • Primary outcome: The probability of a more desirable outcome on day 70 with dalbavancin vs. standard therapy was 47% (95% CI, 39.8% to 55.7%). This does not meet the criterion for superiority of dalbavancin.
    • Secondary outcomes: Clinical efficacy was documented in 73% of dalbavancin-treated patients vs. 72% of patients treated with standard therapy (difference of 1.0%, 95% CI -11.5% to 13.5%), meeting the criterion for noninferiority of dalbavancin. Serious adverse events were similar between patients receiving dalbavancin (40%) and standard therapy (34%). Adverse events resulting in discontinuation of treatment were more frequent with standard therapy (12%) than with dalbavancin (3%).
  • Summary: In patients with complicated SAB who had cleared their blood cultures, two doses of dalbavancin given one week apart were not superior but were noninferior to standard therapy, with comparable safety profiles.

COVID 2025-2026 Vaccines

  • The following COVID vaccines have FDA approval for 2025-26 (as of August 28):
    • Spikevax (LP.8.1 variant, standard dose; Moderna) is approved for >6 months old with medical conditions and everyone >65 years.
    • mNexspike (LP.8.1 variant, low dose; Moderna) is approved for >12 years old with medical conditions and everyone >65 years.
    • Comirnaty (LP.8.1 variant, standard dose; Pfizer) is approved for >5 years old with medical conditions and everyone >65 years.
    • Nuvaxovid (JN.1 variant, same as 2024-2025 vaccines; Novavax) is approved for >12 years old with medical conditions and everyone >65 years.
  • In the package insert for all products, section 8.1 (Pregnancy), Clinical Considerations:
    • "Pregnant individuals infected with SARS-CoV-2 are at increased risk of severe COVID-19 compared with non-pregnant individuals" with no further specific instruction.
  • Final guidance for fall 2025 is pending official CDC/ACIP action (scheduled for September 18).

New or Updated Practice Guidelines

Stewardship in Peripartum Infections

  • A newly published review identifies opportunities for antimicrobial stewardship (AMS) teams to improve antimicrobial prescribing in peripartum infections.
  • The obstetric patient population has not routinely been a focus for AMS interventions despite a high use of antibiotics. Opportunities for AMS teams include determining the baseline antimicrobial use, evaluating diagnostic utilization, reviewing antimicrobial policies and order sets, and reinforcing accurate allergy history.
  • AMS teams can consider developing guidelines, updating order sets and electronic medical record tools, and de-labeling penicillin allergies to improve antimicrobial prescribing in this patient population. Antimicrob Steward Healthc Epidemiol. 2025, e204.

Antimicrobial Shortages (US)

  • New shortages this month:
    • None
  • Resolved shortages this month:
    • None
  • Antimicrobial drugs recently discontinued: 
    • Bezlotoxumab injection (31 Jan 2025, by Merck)
  • Antimicrobial drugs or vaccines in continued reduced supply or unavailable due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons: 
    • Antibacterial drugs:
      • Aminoglycosides:
        • Gentamicin injection (22 Feb 2021)
      • Bacitracin ophthalmic ointment 500 units/gm (12 Sep 2024)
      • Cephalosporins:
        • Cefazolin injection (4 Jun 2018)
        • Cefdinir 300 mg capsules (29 Jun 2023)
        • Cefdinir 125 mg/5 mL, 250 mg/5 mL oral suspension (29 Jun 2023)
        • Cefotaxime injection (10 Jun 2015)
          • FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Provepharm Life Solutions and its distributor Direct Success.
      • Chloramphenicol injection (9 Oct 2023)
      • Fluoroquinolones:
        • Levofloxacin injection in D5W (29 May 2024)
        • Levofloxacin oral solution, 25 mg/mL (15 Sep 2023)
        • Moxifloxacin 400 mg tablets (6 Dec 2023)
      • Glycopeptides, glycolipopeptides, lipopeptides:
        • Vancomycin injection (1 Jun 2015)
      • Lincosamides
        • Clindamycin phosphate injection (25 Jun 2015)
      • Macrolides, azalides:
        • Azithromycin oral suspension, 1 gm packets (20 Nov 2024)
        • Erythromycin lactobionate injection (23 Apr 2025)
      • Neomycin and Polymyxin B sulfates GU irrigant (25 Jun 2023)
      • Nitrofurantoin oral suspension (5 Jun 2018)
      • Nitroimidazoles:
        • Metronidazole injection (20 Oct 2021)
      • Oxazolidinones:
        • Linezolid injection (16 Oct 2024)
      • Penicillins:
        • Amoxicillin, all oral formulations (18 Oct 2022)
        • Amoxicillin-clavulanate, all oral formulations (17 Nov 2022)
        • Dicloxacillin 250 mg, 500 mg capsules (18 Aug 2021)
        • Penicillin G benzathine injection (1 Feb 2023) Availability update
        • Penicillin G benzathine/Penicillin G procaine (31 Mar 2023) Availability update
        • Penicillin VK oral solution 250 mg/5 mL (17 May 2023)
        • Penicillin VK 250 mg, 500 mg tablets (17 May 2023)
      • Rifaximin 200 mg tablets (11 Apr 2024)
    • Antifungal drugs: 
      • Amphotericin B Lipid Complex (5 Aug 2022)
      • Ibrexafungerp 150 mg tablets (3 Dec 2024)
    • Antimycobacterial drugs: 
      • No current shortages
    • Antiparasitic drugs:
      • Mefloquine 250 mg tablets (14 May 2024)
      • Nitazoxanide oral susp 100 mg/5 mL (15 Feb 2024)
    • Antiviral drugs: 
      • Oseltamivir 30 mg, 45 mg, 75 mg capsules (1 Nov 2022)
      • Oseltamivir powder for oral suspension (1 Nov 2022)
      • Peginterferon alfa-2a (Pegasys) (8 Jan 2025)
      • Ribavirin for inhalation solution (23 May 2023)
  • For more information including estimated resupply dates, see ASHP Drug Shortages website.
  • Data shown are current as of 5 Sept 2025.
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