Catherine Li, PharmD, BCIDP, is an infectious diseases pharmacist and codirector of the Antimicrobial Stewardship Program at Women & Infants Hospital in Providence, Rhode Island.

Catherine Li, PharmD, BCIDP

is a protozoan parasite estimated to affect 3.7 million individuals in the United States, including 2.1% of women aged 14 to 59 years. Black women are disproportionately affected, with an increased prevalence rate of 9.6%.

 Potential complications of trichomoniasis include increased risk of other sexually transmitted infections (STIs) including HIV and adverse birth outcomes in pregnancy.

Previously, the recommended treatment for trichomoniasis in HIV-uninfected individuals was a single oral dose of metronidazole. However, a recent randomized controlled trial reported that a 7-day course of metronidazole resulted in 45% fewer treatment failures compared with the single dose (10.9% vs 18.6%; relative risk [RR], 0.55; 95% CI, 0.34-0.70).

 In the 2021 US Centers for Disease Control and Prevention (CDC) STI guidelines, the recommended trichomoniasis treatment regimen was revised to 7 days of metronidazole for all women.

Secnidazole is a nitroimidazole antibiotic with a prolonged half-life of 17 hours, compared with 7 to 8 hours for metronidazole and 12 hours for tinidazole. It was initially approved by the FDA in 2017 for bacterial vaginosis (BV) and is included as an alternative agent and the only single-dose regimen for BV treatment.

 Literature from other countries in the 1970s and 1980s described clinical efficacy of a single dose of secnidazole for treatment of trichomoniasis with parasite eradication rates greater than 90%.

 In June 2021, with the results of this phase 3 trial (NCT03935217), secnidazole received FDA approval for the additional indication of trichomoniasis treatment.

Muzny et al conducted this randomized, double-blind, placebo-controlled, delayed treatment study in postmenarchal females (12 years and older) diagnosed with 

infection. Patients who were pregnant or lactating, had symptomatic vulvovaginal candidiasis, or received antimicrobial treatment in the previous 14 days were excluded. Patients were randomized 1:1 to receive a single dose of secnidazole 2 g oral granules or matching placebo that was taken under direct observation at visit 1. Visit 2 occurred 6 to 12 days later to assess test-of-cure and treatment-emergent adverse events (TEAEs). Patients also received the opposite treatment at this time. For patients not meeting test-of-cure criteria, third and fourth visits were scheduled for additional treatment.

The primary efficacy end point was microbiological cure with the InPouch culture device at the test-of-cure visit in the modified intention-to-treat (mITT) population, defined as patients with a positive 

culture and negative chlamydia and gonorrhea testing at baseline. The analysis was adjusted for presence of trichomoniasis symptoms.

The study enrolled 147 women; 131 were included in the mITT population. More than 90% of patients included were Black/African American. Of note, 29% of patients had BV coinfection and 6.9% were HIV positive. Microbiological cure at test-of-cure was achieved in 92.2% (95% CI, 82.70%-97.41%) of the secnidazole group compared with 1.5% (95% CI, 0.04%-8.04%) of the placebo group (

< .001). Post hoc subgroup analyses in patients with symptoms, without symptoms, BV coinfection, and HIV infection suggested similar results (

TEAEs were assessed in the safety population of all patients who received at least 1 dose of study medication. Overall, the rates of reported AEs were lower in the secnidazole group compared with placebo (14.9% vs 21.9%) and included nausea, diarrhea, headache, and vulvovaginal candidiasis. All reported events were mild and no serious events occurred.

Secnidazole was found to be efficacious for treatment of trichomoniasis in women and was generally well tolerated. Efficacy seemed to be maintained in patients with BV coinfection and in patients with HIV infection; however, larger confirmatory studies are needed for these populations. As an additional single-dose option for trichomoniasis treatment, secnidazole may be advantageous for patients with difficulty adhering to a 7-day metronidazole course. However, with tinidazole as a guideline-recommended single-dose treatment for trichomoniasis and the lack of head-to-head comparative trials, cost-effectiveness will impact secnidazole’s place in therapy. Furthermore, although animal studies did not find adverse developmental outcomes with secnidazole use in pregnancy,

 metronidazole remains the preferred treatment in pregnancy due to a paucity of clinical safety data with tinidazole and secnidazole. One notable advantage of secnidazole over the other nitroimidazoles is that it is the only single-dose treatment regimen for BV. The prevalence of trichomoniasis and BV coinfection was 29% in the present study and has been reported to be as high as 60% to 80% in the literature.

 Prior to secnidazole’s approval, treatment of these patients was limited to multidose regimens with either metronidazole or tinidazole, representing a group that may benefit most from a 2-for-1 single-dose treatment option.

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McClelland RS, Sangare L, Hassan WM, et al. Infection with Trichomonas vaginalis increases the risk of HIV-1 acquisition. 

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Kissinger P, Muzny CA, Mena LA, et al. Single-dose versus 7-day-dose metronidazole for the treatment of trichomoniasis in women: an open-label, randomised controlled trial. 

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Gillis JC, Wiseman LR. Secnidazole. A review of its antimicrobial activity, pharmacokinetic properties and therapeutic use in the management of protozoal infections and bacterial vaginosis. 

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This nitroimidazole antibiotic is shown to be efficacious for this condition. 

Secnidazole Offers Hope as Option for Treating Trichomoniasis in Women

It is estimated that 75% of women will experience an episode of vulvovaginal candidiasis (VVC) in their lifetimes, and with several OTC treatment options, incidence may be underreported.

 Based on the results of the VANISH 303 (NCT03734991) and VANISH 306 (NCT03987620) studies, ibrexafungerp (Brexafemme) was recently FDA approved for VVC treatment. It is a new, first-in-class triterpenoid antifungal and the first new antifungal class since the echinocandins were approved in the early 2000s.

VANISH 303 was a phase 3, multicenter, randomized, double-blind, placebo-controlled superiority study that evaluated ibrexafungerp versus placebo for the treatment of acute VVC.3 Female patients 12 years and older with acute symptomatic VVC (assessed by a vulvovaginal signs and symptoms scale), a positive microscopic examination with 10% potassium hydroxide in a vaginal sample revealing yeast forms, and a normal vaginal pH (≤4.5) were included. Contraceptive use was required for patients of reproductive potential. The study excluded patients who were pregnant or lactating, had an immunocompromising condition, had active cervical or vaginal cancer, or received any antifungal therapy within 28 days of enrollment.

Patients were randomized 2:1 to ibrexafungerp 300 mg twice daily for 1 day or matching placebo and were followed at a test-of-cure visit and a follow-up visit on days 7 to 14 and 21 to 30, respectively. Vulvovaginal samples were collected for fungal culture at screening and at the test-of-cure visit, as well as the follow-up visit if symptoms were present. The primary outcome was clinical cure at the test-of-cure visit at day 10, defined as complete resolution of VVC signs and symptoms without the need for further antifungal treatment. Secondary end points included mycological eradication, clinical improvement (which included partial and complete symptom resolution), and safety.

A total of 376 patients underwent randomization. The modified intent-to-treat population consisted of 286 patients (188 received ibrexafungerp; 98 received placebo) with a positive culture for 1 or greater 

 species. More than 90% of cultures grew 

and the second most common species grown was 

. The ibrexafungerp group experienced higher rates of clinical cure, mycological eradication, clinical improvement, and overall success versus placebo at the follow-up visit. Ibrexafungerp was well tolerated overall, and adverse events were primarily gastrointestinal and mild in severity 

VANISH 303 was followed by VANISH 306, a second phase 3 study with an identical study design that evaluated the efficacy and safety of ibrexafungerp for acute VVC treatment in an international patient population. VANISH 306 concluded with similar results to that of VANISH 303.

 With superior efficacy to placebo and a good safety profile, ibrexafungerp was FDA approved in June as the first nonazole treatment for VVC. Several ongoing clinical trials are evaluating the use of ibrexafungerp in recurrent VVC, invasive pulmonary aspergillosis, refractory or intolerant fungal diseases, and candidiasis caused by 

Prior to the approval of ibrexafungerp, pharmacologic treatment of VVC was limited to topical azole therapy or oral fluconazole.

 Patients with azole-resistant yeast or azole-associated intolerances or contraindications often resort to off-label treatments such as boric acid. Furthermore, fluconazole use in pregnancy has been associated with rare birth defects, although the data are conflicting about the safety of a single 150-mg oral dose.

 Based on observed fetal harm in animal studies, ibrexafungerp is contraindicated in pregnancy, so there remains a lack of systemic VVC treatment options for these patients.

 Of note, 2 pregnancies were reported in VANISH 303; both patients received ibrexafungerp, and both had live births with no reported complications.

Ibrexafungerp is a promising new agent with pharmacologic advantages, including high oral bioavailability, fungicidal activity, and limited observed cross-resistance with other antifungal agents.

 Furthermore, studies have demonstrated that unlike fluconazole, ibrexafungerp retains activity at vaginal pH of 4.5 or less, which is a characteristic feature of VVC and may be an important consideration for treatment and susceptibility testing in patients with azole-refractory VVC.

However, the cost of ibrexafungerp and insurance preferences may limit accessibility. Additional data on the comparative efficacy of ibrexafungerp with azoles, as well as the efficacy and safety in patients with recurrent VVC, will inform ibrexafungerp’s place in VVC therapy. While studies evaluating ibrexafungerp for other indications are ongoing, the approval of ibrexafungerp for the treatment of VVC is a step in the right direction to advance care for patients with fungal infections.

Ibrexafungerp: Paving the Way for Novel Candida Pharmacotherapy

Higher MICs (>2 mg/L) predict 30-day mortality in patients with lower respiratory tract infections caused by 

Rodríguez-Núñez O, Periañez-Parraga L, Oliver A, et al. Open Forum Infect Dis. 2019;6(10):ofz416. doi: 10.1093/ofid/ofz416. 

Ceftolozane/tazobactam (Zerbaxa) is a β- lactam/β-lactamase inhibitor combination that first entered the market after receiving US Food and Drug Administration approval on December 19, 2014, for the treatment of complicated intra-abdominal and urinary tract infections. The labeled dose for these infections is 1.5 grams every 8 hours intravenously, with an infusion time of 1 hour. Dose adjustments are recommended for patients with renal dysfunction. With increasing concern for antibiotic-resistant bacteria, ceftolozane/tazobactam is a potential treatment option for β-lactamase—producing organisms including 

 with derepressed class C cephalosporinase production.

As a time-dependent agent, the activity of ceftolozane/tazobactam is best predicted by the time of antibiotic concentration greater than the minimum inhibitory concentration (MIC). Pharmacokinetic models have demonstrated that for 

 strains with MICs up to 8 mg/L, a higher ceftolozane/tazobactam dose of 3 grams every 8 hours achieves more than 90% probability of attaining a 50% time >MIC in the lung epithelial lining fluid.

 This higher dose was employed in the ASPECT-NP phase 3 trial of ceftolozane/tazobactam versus meropenem for nosocomial pneumonia, which led to the FDA approval for ceftolozane/tazobactam for the treatment of hospital-acquired and ventilator-associated bacterial pneumonia on June 3, 2019.

Prior to the publication of the ASPECT-NP trial, Rodríguez-Núñez et al conducted this retrospective, observational study in 90 patients who received treatment with ceftolozane/tazobactam for a lower respiratory tract infection with susceptible P aeruginosa isolated from at least 1 respiratory or blood culture.

 The study enrolled patients across 13 hospitals in the United States, the United Kingdom, Spain, and France from 2016 to 2018. Susceptibility to ceftolozane/tazobactam was defined as an MIC ≤4 mg/L by Epsilometer test, in concordance with the breakpoints established by the Clinical and Laboratory Standards Institute and the European Committee on Antimicrobial Susceptibility Testing. Patients who received <72 hours of ceftolozane/tazobactam were excluded from the analysis. Standard ceftolozane/tazobactam dose was defined as the labeled dose for intra-abdominal/urinary tract infections (1.5 g every 8 hours for normal renal function), whereas high dose was defined as at least twice the standard dose (

 The primary outcome was 30-day mortality after ceftolozane/tazobactam therapy was initiated. Univariate and multivariate analyses were conducted to identify risk factors associated with mortality. 

The study enrolled 90 patients with a median age of 65 years; their comorbidities included chronic lung disease (43.3%), vascular disease (28.9%), diabetes (16.7%), receipt of a solid organ transplant (8.9%) including lung transplant (5.6%), and cystic fibrosis (6.7%). Pneumonia was the most common lower respiratory tract infection. In terms of illness severity, the cohort had a median Charlson Comorbidity Index score of 5. Of all infections, 36.7% were ventilator associated; 34.4% of patients presented with septic shock, and 12.2% required continuous renal replacement therapy. As for 

 MIC distribution, 24.4% of patients had isolates with an MIC ≤1 mg/L, 51.1% had isolates with an MIC 1-2 mg/L, and 24.4% had isolates with an MIC of 4 mg/L. 

The overall 30-day mortality rate was 27.8%. In the univariate analysis, 2 factors were identified to be associated with increased mortality: a higher Charlson Comorbidity Index score (OR, 1.2; P = .029) and septic shock (OR, 5.9; P <.001). Decreased mortality was observed in patients who received high-dose ceftolozane/tazobactam with a corresponding MIC ≤2 mg/L (OR, 0.3; P = .033). A mortality benefit was not seen with standard ceftolozane/tazobactam dosing for MIC ≤2 mg/L (OR, 1.1; P = .847). Although the use of high-dose ceftolozane/tazobactam trended toward decreased mortality for MIC ≤1 mg/L, MIC 1-2 mg/L, and MIC 3-4 mg/L, the differences were not statistically significant. The multivariate analysis demonstrated similar results as the univariate analysis: a higher Charlson Comorbidity Index score (OR, 1.27; P = .019), septic shock (OR, 7.96; P <.0001), and a ceftolozane/tazobactam MIC >2 mg/L (OR, 3.33; P = .045) were independently associated with 30-day mortality. Four adverse events attributable to ceftolozane/tazobactam occurred,: leukopenia, encephalopathy with myoclonus, renal failure, and hepatitis. 

Although this study was retrospective and observational in nature, the cohort included patients with multidrug-resistant and extensively drug-resistant 

 respiratory tract infections with significant comorbidities and severity-of-illness indicators. The mortality benefit of high-dose ceftolozane/tazobactam in patients with MICs ≤2 mg/L strengthens the case for the higher dose of ceftolozane/tazobactam for respiratory tract infections, now FDA approved. In this study, MIC >2 mg/L was a stronger predictor for increased mortality than was the ceftolozane/tazobactam dosing strategy, reinforcing the difficulty of treating patients who have these resistant organisms. The association of increased MIC with risk of clinical failure has been described in other studies as well.

 Further research on strategies to optimize the pharmacokinetic and pharmacodynamic parameters of these novel agents in the age of antimicrobial resistance is needed to improve outcomes. When using ceftolozane/ tazobactam to treat patients with 

 respiratory tract infections, the use of extended or continuous antibiotic infusion and/or combination therapy with other active antibiotic agents should be considered, particularly if targeting higher MIC values.

Catherine Li, PharmD, is currently a PGY-2 infectious diseases pharmacy resident at Beth Israel Deaconess Medical Center in Boston, MA. Her clinical interests include antimicrobial stewardship, antimicrobial resistance, and transitions of care.

* indicates active member of the Society of Infectious Diseases Pharmacists 

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Kollef MH, Nová&#269;ek M, Kivistik Ü, et al. Ceftolozane-tazobactam versus meropenem for treatment of nosocomial pneumonia (ASPECT-NP): a randomised, controlled, double-blind, phase 3, non-inferiority trial. 

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Rodríguez-Núñez O, Periañez-Parraga L, Oliver A, et al. Higher MICs (>2 mg/L) predict 30-day mortality in patients with lower respiratory tract infections caused by multidrug- and extensively drug-resistant 

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Zerbaxa [package insert]. Whitehouse Station, NJ: Merck & Co, Inc; 2019.

Escola-Verge L, Pigrau C, Los-Arcos I, et al. Ceftolozane/tazobactam for the treatment of XDR 

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Pilmis B, Petitjean G, Lesprit P, et al. Continuous infusion of ceftolozane/tazobactam is associated with a higher probability of target attainment in patients infected with 

. 2019;38(8):1457-1461. doi: 10.1007/s10096-019-03573-4.

Davis SE, Ham J, Hucks J, et al. Use of continuous infusion ceftolozane—tazobactam with therapeutic drug monitoring in a patient with cystic fibrosis. 

. 2019;76(8):501-504. doi: 10.1093/ajhp/zxz011.

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 with MIC values between 4 and 32&thinsp;mg/L. 

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Entering the Ring: Oral Vancomycin Versus Metronidazole for 

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Where to Treat Uncomplicated HCV? Assessing the Impact of Shifting Care From Specialists to PCPs

Postulates About the Prostate: Fosfomycin for Chronic Bacterial Prostatitis

When using ceftolozane/ tazobactam to treat patients with P aeruginosa respiratory tract infections, the use of extended or continuous antibiotic infusion and/or combination therapy with other active antibiotic agents should be considered, particularly if targeting higher MIC values.

Consider the MIC: Treating Respiratory Infections Caused by Pseudomonas aeruginosa With Ceftolozane/Tazobactam

Cowart K, Worley M, El Rouby N, Sando K. Evaluation of FDA Boxed Warning on Prescribing Patterns of Fluoroquinolones for Uncomplicated Urinary Tract Infections. 

. 2019; 53(12):1192-1199. doi:10.1177/1060028019865224.

The treatment of urinary tract infections in the outpatient setting represents an area with an opportunity for antimicrobial stewardship efforts. According to the 2010 Infectious Diseases Society of America (IDSA) guidelines, nitrofurantoin, trimethoprim-sulfamethoxazole, and Fosfomycin are recommended first-line antibiotic treatment options for acute uncomplicated cystitis. Although fluoroquinolones are efficacious against common urinary pathogens, they are associated with a “propensity for collateral damage” and consequently should be reserved for patients who are unable to receive treatment with the first-line agents.

On May 12, 2016, the US Food and Drug Administration (FDA) issued a safety announcement reinforcing the recommendation to avoid fluoroquinolones in uncomplicated urinary tract infections (uUTI), as well as in acute sinusitis and acute bronchitis. Other treatment options are often available for these uncomplicated infections to avoid the “disabling and potentially permanent serious side effects” of fluoroquinolones on the tendons, muscles, joints, nerves, and central nervous system.

 On July 26, 2016, this statement was formally added to the boxed warning on fluoroquinolone drug labelling.

Cowart and colleagues conducted a retrospective cohort study at 6 family medicine clinics within the University of Florida Academic Health Center in order to evaluate the impact of the 2016 FDA boxed warning on fluoroquinolone prescribing rates for uUTIs.

 Antibiotic prescribing was assessed pre-FDA boxed warning (January 1, 2016 through July 26, 2016) and post-FDA boxed warning (July 27, 2016 through December 31, 2016). The analysis included women aged 18-65 years who had a clinic visit that listed uUTI as the primary or secondary billable diagnosis code and generated an antibiotic in the electronic medical record during the visit. Patients with complicated UTI, immunosuppressive disease, diabetes mellitus, recent antibiotic prescriptions, or recent hospitalization were excluded.  

A total of 436 patients were included in the analysis with 274 patients in the pre-FDA boxed warning group and 162 patients in the post-FDA boxed warning group. Baseline characteristics were similar between groups and nitrofurantoin was the most commonly prescribed treatment during both time periods. Of note, only 60% of patients in both groups presented with urinary symptoms.

For the primary outcome, fluoroquinolones were prescribed in 38% of patients pre-FDA boxed warning and in 30% of patients post-FDA boxed warning (8% reduction; P = 0.08). A step-wise logistic regression was performed to identify predictors of fluoroquinolone prescribing in a subgroup of 371 patients with renal function data available. Age ≥ 58 years and chronic kidney disease, defined as a glomerular filtration rate <60 mL/min/1.73m

 were both associated with a statistically significant increase in fluoroquinolone prescribing. Although the FDA boxed warning was associated with a 33% decrease in fluoroquinolone prescribing, this finding did not meet statistical significance (

Secondary outcomes of the study included concordance of antibiotic prescribing with clinical practice guidelines and treatment failure. The overall concordance of antibiotic dose, frequency and duration of therapy with the IDSA recommendations was 26%, and ranged from 15% to 47% between the clinic sites. Treatment failure, defined as a second prescribed antibiotic, emergency department visit, or hospitalization for UTI, occurred in 45 patients (10%).  

The authors of this study concluded that the 2016 FDA boxed warning did not significantly decrease the rate of fluoroquinolone prescribing for uUTIs in their family medicine practice clinics. Although this study had limitations, including its single-center, retrospective design, the shorter, 5-month time period after July 2016, and the lack of antibiotic cost analysis, the findings were corroborated by a similar study at the University of North Carolina Health Care System from April 2014 to August 2017.

These results highlight the need for antimicrobial stewardship initiatives in inpatient, outpatient, and emergency department settings to optimize the treatment of uUTIs in regard to antibiotic selection, dosing, and duration of treatment. Furthermore, 40% of the patients in this study received antibiotic prescriptions for asymptomatic bacteriuria, supporting other published literature on the need for education regarding the appropriate use of antibiotics in this context.

Notably, patients aged ≥ 58 years were 3-times more likely to be prescribed a fluoroquinolone for uUTIs in this study. Given the increased risk of severe fluoroquinolone-induced adverse effects and increased difficulty of symptomatic UTI diagnosis

with older age, this may represent a valuable patient population for targeted antimicrobial stewardship.

 Strategies such as decision algorithms, prescriber education, peer comparison, and computer-based order sets have been shown to effectively decrease inappropriate antibiotic use.

 Specifically at primary care practice sites, peer comparison was found to have a sustained benefit even 12 months after the intervention was stopped, confirming the importance of establishing impactful methods of antimicrobial stewardship.

 Interventions such as these will be even more important in the future, with the pending Joint Commission requirement of antimicrobial stewardship in ambulatory care centers. 

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Evaluating the impact of the 2016 FDA boxed warning on fluoroquinolone prescribing rates for uncomplicated urinary tract infections.

Catherine Li, PharmD, BCIDP

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