Antibacterial fluoroquinolones (FQs) are frequently used in treating infections. However, the value of FQs is debatable due to their association with severe adverse effects (AEs). The Food and Drug Administration (FDA) issued safety warnings concerning their side-effects in 2008, followed by the European Medicine Agency (EMA) and regulatory authorities from other countries. Severe AEs associated with some FQs have been reported, leading to their withdrawal from the market. New systemic FQs have been recently approved. The FDA and EMA approved delafloxacin. Additionally, lascufloxacin, levonadifloxacin, nemonoxacin, sitafloxacin, and zabofloxacin were approved in their origin countries. The relevant AEs of FQs and their mechanisms of occurrence have been approached. New systemic FQs present potent antibacterial activity against many resistant bacteria (including resistance to FQs). Generally, in clinical studies, the new FQs were well-tolerated with mild or moderate AEs. All the new FQs approved in the origin countries require more clinical studies to meet FDA or EMA requirements. Post-marketing surveillance will confirm or infirm the known safety profile of these new antibacterial drugs. The main AEs of the FQs class were addressed, highlighting the existing data for the recently approved ones. In addition, the general management of AEs when they occur and the rational use and caution of modern FQs were outlined. 

/pdf/overview-of-side-effects-of-antibacterial-fluoroquinolones-1imjb23r.pdf

Overview of Side-Effects of Antibacterial Fluoroquinolones: New Drugs versus Old Drugs, a Step Forward in the Safety Profile?

Antimicrobial resistance continues to erode our therapeutic armamentarium for treating patients with bacterial infections. Clinicians are now encountering infections that are susceptible to few or ...

Needed: Antimicrobial Development.

Neisseria gonorrhoeae has developed resistance to all first-line recommended therapies, making gonococcal antimicrobial resistance a major public health concern given limited antibiotic options currently and an even smaller antimicrobial development pipeline. Since the release of the Centers for Disease Control and Prevention (CDC) 2015 STD Treatment Guidelines, azithromycin, part of the 2015 dual-drug treatment regimen, has had a rapid rise in resistance. The 2020 CDC Gonorrhea Treatment Recommendations and the 2021 Sexually Transmitted Infections (STI) Treatment Guidelines were developed weighing the priorities of treating the individual, protecting the population, and preventing antimicrobial resistance.Gonorrhea subject matter experts (SME) generated 8 key questions and conducted a literature review of updated data from 2013 to 2019 on gonorrhea antimicrobial resistance, treatment failures, clinical trials, and other key topics. More than 2200 abstracts were assessed, and 248 clinically relevant articles were thoroughly reviewed. SMEs also evaluated N gonorrhoeae antimicrobial resistance data from the Gonococcal Isolate Surveillance Project (GISP).Although there have been reports of ceftriaxone treatment failures internationally, GISP data suggest that ceftriaxone minimal inhibitory concentrations (MICs) have remained stable in the United States, with < 0.1% exhibiting an "alert value" MIC (> 0.25 mcg/mL). However, GISP documented a rapid rise in the proportion of isolates with an elevated MIC (≥ 2.0 mcg/mL) to azithromycin-nearly 5% in 2018. At the same time, new pharmacokinetic/pharmacodynamic data are available, and there is greater recognition of the need for antimicrobial stewardship.The 2021 CDC STI Treatment Guidelines now recommend 500mg ceftriaxone intramuscularly once for the treatment of uncomplicated gonorrhea at all anatomic sites. If coinfection with chlamydia has not been excluded, cotreatment with doxycycline 100mg twice daily for 7 days should be added. Few alternative therapies exist for persons with cephalosporin allergies; there are no recommended alternative therapies for N gonorrhoeae infection of the throat. 

OUP accepted manuscript

Background Rectal gonorrhoea is a common sexually transmitted infection with increasing antimicrobial resistance requiring optimization of available treatments. Objectives This systematic review aimed to assess the efficacy of current treatments, previously trialled treatments and new emerging treatments for rectal Neisseria gonorrhoeae (NG). Methods Online bibliographic databases were search from 1 January 1946 to 14 August 2020. All randomized controlled trials (RCTs) with rectal NG data among participants aged 15 years or above and published in English were included. Random effects meta-analyses were used to estimate overall treatment efficacy, defined as microbiological cure. Sub-group analyses included stratifying by diagnostic assay, by dual versus monotherapy, and by currently recommended treatments (e.g. ceftriaxone ± azithromycin) versus previously trialled but not recommended treatments (e.g. amoxicillin) versus emerging treatments (e.g. zoliflodacin). The study protocol was registered on PROSPERO (CRD42020202998). Results 54 studies including 1813 participants and 44 treatment regimens were identified. The overall summary treatment efficacy for rectal NG was 100.0% (95% CI: 99.9%-100.0%; I2 = 0.0%; P = 0.86). Efficacy estimates for monotherapies (100.0%; 95% CI: 99.88%-100.0%; I2 = 0.00%; P = 0.97) and dual therapies (100.0%; 95% CI: 97.65%-100.0%; I2 = 56.24%; P = 0.03) were similar. Efficacy was highest for current treatments (100.00%; 95% CI: 99.96%-100.00%; I2 = 0.00%; P = 0.98) versus emerging treatments (97.16%; 95% CI: 86.79%-100.00%; I2 = 0.00%; P = 0.84). There were no trials exclusively investigating rectal NG and small sample size was a limitation in most trials. Conclusions Currently recommended treatments containing ceftriaxone, as mono or dual therapy, are effective. Emerging drugs such as zoliflodacin may be potentially useful for rectal NG but further data are needed.

Treatment efficacy for pharyngeal Neisseria gonorrhoeae: a systematic review and meta-analysis of randomized controlled trials

Antimicrobial treatment and resistance in sexually transmitted bacterial infections.

BackgroundWe evaluated single oral dose of delafloxacin versus single intramuscular ceftriaxone in participants with uncomplicated urogenital gonorrhea (primary objective). Secondary objectives included the efficacy, safety, and tolerability of delafloxacin versus ceftriaxone for uncomplicated uroge

Efficacy and Safety of Single-Dose Oral Delafloxacin Compared With Intramuscular Ceftriaxone for Uncomplicated Gonorrhea Treatment: An Open-Label, Noninferiority, Phase 3, Multicenter, Randomized Study

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Efficacy and Safety of Single-Dose Oral Delafloxacin Compared With Intramuscular Ceftriaxone for Uncomplicated Gonorrhea Treatment: An Open-Label, Noninferiority, Phase 3, Multicenter, Randomized Study