Sanford Guide ID Update features current developments in infectious diseases, curated by the Sanford Guide Editorial Board. Links marked with an asterisk (*) provide details to Web Edition subscribers, while all other links are universal. To sign up for ID updates to your inbox, register here.
SARS-CoV-2 / COVID-19
Sanford Guide SARS-CoV-2 / COVID-19 material is freely available to all for the course of the pandemic.
- Important Note August 2021 re Delta Variant:
- Other than hypertransmissibility and high peak viral loads, current understanding of SARS-CoV-2 infection with the currently predominant Delta variant, is very limited although improving daily. Delta has many unique properties. Most knowledge of clinical, epidemiologic, therapeutic, and diagnostic aspects of infection and COVID-19 are based on studies done in the pre-Delta era and recommendations based on references that pre-date Delta should be interpreted in that context. Of course, we will continue to update COVID-19 information and recommendations based on new developments.
- July 28: The US FDA revises the EUA to authorize baricitinib alone for the treatment of COVID-19 in hospitalized adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO. Under the revised EUA, baricitinib is no longer required to be administered with remdesivir. Fact sheet here.
- July 28: The US FDA revises the EUA for Casirivimab + Imdevimab authorizing it for emergency use as post-exposure prophylaxis for COVID-19 in adults and pediatric individuals (12 years of age and older weighing at least 40 kg) who are at high risk for progression to severe COVID-19, including hospitalization or death. It remains authorized for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. Fact sheet here.
- CDC: Interim public health recommendations for fully vaccinated people here.
- Currently authorized vaccines. See COVID-19 Prevention for table summarizing use and data.
- COVID-19 vaccination in cancer patients: preliminary recommendations from NCCN here.
- 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;374:n1703).
- 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.
US FDA New Product Approval
- Fexinidazole* Tablets for the treatment of both the first-stage (hemolymphatic) and second-stage (meningoencephalitic) human African trypanosomiasis (HAT) due to Trypanosoma brucei gambiense in patients 6 years of age and older and weighing at least 20 kg. Recommended dosage (patients ≥35 kg): 1800 mg once daily x4 days, then 1200 mg once daily x6 days (with food). Product availability: 600 mg tablets.
US FDA Expanded Approvals
- Secnidazole* (Solosec) for the treatment of trichomoniasis caused by T. vaginalis in adults. The recommended dosage is a single 2 gram packet of granules taken once orally, with or without food. Sexual partners of infected patients should be treated simultaneously. Secnidazole was initially approved in 2017 for bacterial vaginosis (BV) in adult women. Dosage for both indications is the same.
- Zoster Vaccine Recombinant, Adjuvanted (Shingrix) for the prevention of shingles (herpes zoster) in adults aged 18 years of age or older who are or who will be at increased risk of shingles due to immunodeficiency or immunosuppression caused by known disease or therapy. It was initially approved in 2017 for the prevention of shingles in adults 50 years of age or older, in whom it is administered in two intramuscular doses 2-6 months apart. However, for adults who are or will be immunodeficient or immunosuppressed due to known disease or therapy and who would benefit from a shorter vaccination schedule, the second dose can be administered 1 to 2 months after the first dose.
- CDC recommendations to US health care providers regarding treatment, pre-exposure prophylaxis, and postexposure prophylaxis of plague (MMWR Recomm Rep 2021;70(3):1-27). Available here.
- Sexually Transmitted Infection Treatment Guidelines, 2021 (MMWR Recomm Rep 2021;70(4):1-187). The guidelines were last updated in 2015. Available here.
New or Updated Clinical Practice Guidelines
- Diagnosis and management of acute hematogenous osteomyelitis in pediatrics, from the Pediatric Infectious Diseases Society and the Infectious Diseases Society of America (J Pediatric Infect Dis Soc 2021 Aug 5 [online ahead of print]). The guideline is available here.
- Immunizations in patients with inflammatory bowel disease (part 1: live vaccines), from the Canadian Association of Gastroenterology and endorsed by the American Gastroenterological Association (Gastroenterology 2021;161:669). The guideline is available here.
- Immunizations in patients with inflammatory bowel disease (part 2: inactivated vaccines), from the Canadian Association of Gastroenterology and endorsed by the American Gastroenterological Association (Gastroenterology 2021;161:669). The guideline is available here.
- Danish national guidelines for the treatment of adult patients with Clostridioides difficile infection and the use of fecal microbiota transplantation (Scand J Gastroenterol 2021 July 14 [online ahead of print]). Available here.
- Clinical practice guidelines for the treatment of Helicobacter pylori infection in Korea 2020 (Korean J Intern Med 2021;36:807). The guidelines were last updated in 2013. Available here.
- Updated WHO guidelines for the management of symptomatic sexually transmitted infections. Geneva: World Health Organization; 2021. These guidelines update the 2003 publication. Available here.
Drug Shortages (US)
- Antimicrobial drugs or vaccines in reduced supply or unavailable (as of August 10, 2021) due to increased demand, manufacturing delays, product discontinuation by a specific manufacturer, or unspecified reasons:
- New on the list since July 13, 2021: None
- Shortage recently resolved: Ceftazidime-avibactam injection, Cidofovir injection, Chloroquine tablets
- Antibacterial and antimycobacterial drugs in continued reduced supply:
- Aminoglycosides: Amikacin injection, Gentamicin injection, Neomycin tablets, Tobramycin injection
- Carbapenems: Meropenem injection
- Cephalosporins: Cefazolin injection, Cefepime injection, Cefotaxime injection (FDA is allowing temporary importation of product from SteriMax in Canada, in conjunction with Apollo Pharmaceuticals and its distributor FFF Enterprises. Click here for details), Cefotetan injection, Ceftazidime injection, Ceftolozane-tazobactam injection
- Clindamycin injection
- Ethambutol tablets
- Fluoroquinolones: Ciprofloxacin 0.3% ophthalmic solution, Gemifloxacin tablets
- Glycopeptides, glycolipopeptides, lipopeptides: Vancomycin injection
- Macrolides/azalides: Azithromycin ophthalmic solution 1% (unavailable)
- Methanamine hippurate tablets
- Nitrofurantoin oral suspension
- Penicillins: Ampicillin-sulbactam injection, Piperacillin-tazobactam injection
- Tetracyclines: None
- Topical (miscellaneous) antibacterials: Bacitracin ophthalmic ointment, Neomycin and Polymyxin B sulfates GU irrigant, Neomycin and Polymyxin B sulfates and Dexamethasone ophthalmic ointment, Sulfacetamide 10%/Prednisolone 0.2% ophthalmic ointment (unavailable), Sulfanilamide 15% vaginal cream (unavailable)
- Antifungal, antiparasitic, and antiviral drugs in continued reduced supply:
- Clotrimazole 10 mg oral troches
- Hydroxychloroquine tablets
- Vaccines in continued reduced supply:
- Hepatitis B vaccine recombinant
- Antimicrobial drugs recently discontinued:
- Mupirocin calcium 2% cream (Bactroban [GSK], in June 2020), Bacitracin injection (in February 2020), Interferon alfa-2b (Intron A, in October 2019), Mupirocin calcium 2% nasal ointment (Bactroban Nasal [GSK], in August 2019), Quinidine gluconate IV (in December 2017), Terbinafine granules (in May 2017), MenHibrix (in February 2017), Elvitegravir (Vitekta, in December 2016), Peginterferon alfa-2b (in February 2016; 50 mcg vials still available in limited quantities), Boceprevir (in December 2015), Permethrin 1% topical lotion (in September 2015).
- For more detailed information including estimated resupply dates, see https://www.ashp.org/Drug-Shortages/