A study in Frontiers in pharmacology examined the use of the antimicrobial agent ozenoxacin against staphylococci and streptococci in pediatric patients with impetigo by reviewing the available clinical evidence of efficacy and safety data.1
Researchers searched PubMed, Google Scholar, ClinicalTrials.gov, and the FDA and European Medicines Agency (EMA) websites using the keywords “ozenoxacin,” “impetigo,” “antibiotics. topicals ”,“ retapamulin ”,“ mupirocin ”,“ fusidic acid ”,“ quinolone ”and“ pediatric patients ”.
There were 3 studies2,3,4– one phase 1 study and two phase 3 studies – which had similar inclusion / exclusion criteria for pediatric patients and the same treatment regimen of topical application of ozenoxacin 1% cream or vehicle twice daily during 5 days. Therapy results were evaluated before, during, at the end of treatment and during follow-up trials and included clinical evaluations. For more information on each, please see here.
The success of these trials was a Skin Infection Rating Scale (SIRS) score of 0 for exudate / pus, scabs, positive thermotouch, and pain and 0 or 1 for erythema, l Tissue edema and itching or improvement, defined as a 10% or more decrease in the total SIRS score from baseline, according to the article. The main measure of the effectiveness of the studies reviewed was the clinical response (success or failure) at the end of treatment.
In the first phase 3 trial,3 in which a randomized comparison of ozenoxacin, placebo and retapamulin was conducted showed that ozenoxacin is superior to placebo in terms of 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 clinical success, and the remaining 50% showed clinical improvement.
For microbiological efficacy, please read here.
Regarding adverse events (AEs), 49 were reported across studies in 38 (5.9%) patients, including mild to moderate. Overall, ozenoxacin was well tolerated and the reported adverse events were not related to treatment.
“Due to its bactericidal activity against susceptible and resistant bacteria and its lack of quinolone-induced cartilage and bone damage, ozenoxacin may be an effective option, given the restriction of the use of fluoroquinolones in the pediatric population to avoid damage to the musculoskeletal system. system, ”the authors wrote.
Ozenoxacin is a necessary option to help fight the global spread of antibiotic resistance to treatment. Further studies with real-life analyzes and pharmacoeconomic evaluation are needed to confirm its role as first and second-line treatment in children with impetigo and to assess its skin absorption, particularly in patients with impetigo. of chronic skin diseases, the article concludes.
This article was originally published by sister publication Dermatology Times.
- Davino G, D’Alvano T, Esposito S. The use of ozenoxacin in pediatric patients: clinical evidence, efficacy and safety. Before Pharmacol. 2020; 11: 559708. doi: 10.3389 / fphar.2020.559708
- Gropper S, Cepero AL, Santos B, Kruger D. Systemic bioavailability and safety of topical 1% ozenoxacin cream twice daily in adults and children with impetigo.Microbiol of the future. 9 (8 Suppl. 1), S33 – S40. 10.1080 / 14787210.2019.1573671
- Gropper S, Albareda N, Chelius K, et al. Ozenoxacin 1% Cream in the Treatment of Impetigo: a Multicenter, Randomized, Placebo-Controlled, Retapamulin Clinical Trial.Microbiol of the future. 9 (9). 1013-1023. 10.2217 / fmb.14.78
- Rosen T, Albareda N, Rosenberg N, et al. Efficacy and safety of ozenoxacin cream for the treatment of adult and pediatric patients with impetigo: a randomized clinical trial.JAMA Dermatol.154 (7): 806-813. 10.1093 / jac / 49.3.455