Ozenoxacin Treatment for Pediatric Patients

A study in Frontiers in Pharmacology dove into the use of ozenoxacin antimicrobial agent against both staphylococci and streptococci in pediatric patients with impetigo by examining clinical evidence of efficacy, and safety data available.¹

The researchers searched for literature on PubMed, Google Scholar, ClinicalTrials.gov, and the FDA and Europeans Medicines Agency (EMA) websites using the keywords “ozenoxacin,” “impetigo,” “topical antibiotics,” “retapamulin,” “mupirocin,” “fusidic acid,” “quinolone,” and “pediatric patients.”

There were 3 studies^2,3,4—one phase 1 study and two phase 3 studies—which had similar inclusion/exclusion criteria for pediatric patients and the same treatment schedule of a topical application of ozenoxacin 1% cream or vehicle twice daily for 5 days. Results of the therapy were assessed before, during, at the end of treatment, and at follow up for the trials and included clinical evaluations. For more information on each, please review here. 

Success of these trials was a skin infection rating scale (SIRS) score of 0 for exudate/pus, crusts, positive thermotouch and pain and 0 or 1 for erythema, tissue oedema and itching or as improvement, defined as a 10% or greater decrease in total SIRS score compared with baseline, according to the article. The primary efficacy end point of the studies examined was the clinical response (success or failure) at the end of the treatment.

In the first phase 3 trial,³ in which a randomized comparison of ozenoxacin, placebo, and retapamulin, was conducted found that ozenoxacin is superior to placebo in clinical efficacy and in the intention-to-treat population, was as effective as retapamulin. These results were confirmed by the second randomized, double-blind, phase 3 study.⁴ In the phase 1 study,² 18 of 36 patients (50%) were labeled as a clinical success, and the other 50% had a clinical improvement.

For the microbiological efficacy, please read here.

As for adverse events (AEs), there were 49 reported across all of the studies in 38 (5.9%) patients of which were either mild or moderate. Overall, the ozenoxacin was well-tolerated, and the reported adverse events were not related to treatment. 

“Due to its bactericidal activity against both susceptible and resistant bacteria and its lack of quinolone-induced lesions in cartilage and bone, ozenoxacin could be an effective option, considering the restriction of the use of fluoroquinolones in the pediatric population to avoid damage to the musculoskeletal system,” the authors wrote.

Ozenoxacin is an option needed to help combat the global spread of antibiotic resistance to treatments. More studies with real-life analyses and pharmacoeconomic evaluation are needed to confirm its role as first-line and second-line therapy in children with impetigo and to evaluate its dermal absorption, especially in patients with chronic cutaneous diseases, the article concluded.

Reference:

1. Davino G, D’Alvano T, Esposito S. The use of ozenoxacin in pediatric patients: clinical evidence, efficacy and safety. Front Pharmacol. 2020;11:559708. doi:10.3389/fphar.2020.559708
2. Gropper S., Cepero A. L., Santos B., Kruger D. (2014b). Systemic bioavailability and safety of twice-daily topical ozenoxacin 1% cream in adults and children with impetigo. Future Microbiol. 9(8 Suppl. l), S33–S40. 10.1080/14787210.2019.1573671
3. Gropper S., Albareda N., Chelius K., Kruger D., Mitha I., Vahed Y., et al. (2014a). Ozenoxacin 1% cream in the treatment of impetigo: a multicenter, randomized, placebo- and retapamulin-controlled clinical trial. Future Microbiol. 9 (9). 1013–1023. 10.2217/fmb.14.78
4. Rosen T., Albareda N., Rosenberg N., Alonso F. G., Roth S., Zsolt I., et al. (2018). Efficacy and safety of ozenoxacin cream for treatment of adult and pediatric patients with impetigo: a randomized clinical trial. JAMA Dermatol 154 (7):806–813. 10.1093/jac/49.3.455