ozenoxacin and Impetigo

Impetigo, a highly contagious bacterial skin infection commonly occurring in young children, but adults may also be affected. The superficial skin infection is mainly caused by Staphylococcus aureus (S. aureus) and less frequently by Streptococcus pyogenes (S. pyogenes). Antimicrobial resistance has become a worldwide concern and needs to be addressed when selecting treatment for impetigo patients. An evidence-based impetigo treatment algorithm was developed to address the treatment of impetigo for pediatric and adult populations.. An international panel of pediatric dermatologists, dermatologists, pediatricians, and pediatric infectious disease specialists employed a modified Delphi technique to develop the impetigo treatment algorithm. Treatment recommendations were evidence-based, taking into account antimicrobial stewardship and the increasing resistance to oral and topical antibiotics.. The algorithm includes education and prevention of impetigo, diagnosis and classification, treatment measures, and follow-up and distinguishes between localized and widespread or epidemic outbreaks of impetigo. The panel adopted the definition of localized impetigo of fewer than ten lesions and smaller than 36 cm2 area affected in patients of two months and up with no compromised immune status. Resistance to oral and topical antibiotics prescribed for the treatment of impetigo such as mupirocin, retapamulin, fusidic acid, have been widely reported.. When prescribing antibiotics, it is essential to know the local trends in antibiotic resistance. Ozenoxacin cream 1% is highly effective against S. pyogenes and S. aureus, including methycyllin-susceptible and resistant strains (MRSA), and may be a suitable option for localized impetigo.J Drugs Dermatol. 2021;20(2):134-142. doi:10.36849/JDD.5475 \ \ THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

Topics: Aminopyridines; Anti-Bacterial Agents; Antimicrobial Stewardship; Bridged Bicyclo Compounds, Heterocyclic; Critical Pathways; Delphi Technique; Diterpenes; Drug Resistance, Bacterial; Evidence-Based Medicine; Fusidic Acid; Humans; Impetigo; Microbial Sensitivity Tests; Mupirocin; Practice Guidelines as Topic; Quinolones; Skin Cream; Staphylococcus aureus; Streptococcus pyogenes; Systematic Reviews as Topic

Impetigo is a contagious bacterial infection that affects the superficial skin layers. Increasing worldwide antimicrobial resistance (AMR) to existing topical agents commonly prescribed to treat impetigo is central to treatment failure. The Worldwide Health Organization developed a global action plan on AMR, but omitted information about AMR stewardship programs for topical antibiotics.. The review aims to provide information to clinicians and stakeholders regarding AMR and antimicrobial stewardship on topical antimicrobial drugs for impetigo treatment.. The literature searches reviewed the status of AMR to current topical antibiotics in impetigo, current therapeutic behavior, and concordance with antimicrobial stewardship principles. Two international panels convened to discuss the output of the searches, and the results of the panel discussions were used in the development of the manuscript.. The literature search included clinical trials, research studies, clinical guidelines, consensus papers, and reviews (if they provided original data), published between January 2008 and May 2019. The articles were selected based on clinical relevancy of impetigo management, clinical efficacy, and safety of the treatment and antimicrobial resistance. The searches resulted in one-hundred and ninety-eight articles. After applying the eligibility criteria, nineteen articles met inclusion criteria and were considered in the present review.. While published antimicrobial stewardship guidelines have focused on systemic antibiotics, few studies have attempted to evaluate topical antibiotic prescribing practices for impetigo treatment. Many of the topical impetigo treatments currently in use have developed resistance. The appropriate use of topical ozenoxacin can help eradicate impetigo while minimizing AMR.J Drugs Dermatol. 20(4):366-372. doi:10.36849/JDD.5795.

Topics: Administration, Cutaneous; Aminopyridines; Anti-Bacterial Agents; Antimicrobial Stewardship; Drug Prescriptions; Drug Resistance, Bacterial; Humans; Impetigo; Microbial Sensitivity Tests; Practice Guidelines as Topic; Quinolones; Staphylococcus aureus; Treatment Outcome

Topics: Administration, Topical; Aminopyridines; Anti-Bacterial Agents; Child; Child, Preschool; Humans; Impetigo; Infant; Quinolones

Ozenoxacin is one of the potent quinolone antibiotics, recently approved by the United States Food and Drug Administration (USFDA) with reported pharmacology to treat the impetigo. The demand for better acting topical formulation is increasing day by day. The present review is an attempt to summarize the facts behind the chemistry and biological applications of Ozenoxacin. Mechanism of Action: This novel drug being a quinolone antibiotic compound, acts by inhibiting DNA gyrase A and topoisomerase IV and affects supercoiling, supercoil relaxation, chromosomal condensation, chromosomal decatenation and many others. Pharmacology: Ozenoxacin has demonstrated to have a bactericidal activity against organisms, such as Staphylococcus aureus and Staphylococcus pyogenes. Ozenoxacin is non-fluorinated quinolone and being developed for the other dermatological bacterial infections as well. No sign of genotoxicity was observed when tested experimentally.. The present review also covers the complete picture of pharmacokinetics, clinical trials, toxicity and future scope and possible avenues in this arena.

Topics: Aminopyridines; Animals; Anti-Bacterial Agents; Drug Discovery; Drug Interactions; Humans; Impetigo; Quinolones

Impetigo is the most common bacterial skin infection in children. Treatment is becoming complicated due to the development of antimicrobial resistance, especially in the main pathogen, Staphylococcus aureus. Ozenoxacin, a novel non-fluorinated topical quinolone antimicrobial, has demonstrated efficacy in impetigo. Areas covered: This article reviews the microbiology, pharmacodynamic and pharmacokinetic properties of ozenoxacin, and its clinical and microbiological efficacy in impetigo. Expert opinion: In an environment of increasing antimicrobial resistance and concurrent slowdown in antimicrobial development, the introduction of a new agent is a major event. Ozenoxacin is characterized by simultaneous affinity for DNA gyrase and topoisomerase IV, appears to be impervious to certain efflux pumps that confer bacterial resistance to other quinolones, shows low selection of resistant mutants, and has a mutant prevention concentration below its concentration in skin. These mechanisms protect ozenoxacin against development of resistance, while the absence of a fluorine atom in its structure confers a better safety profile versus fluoroquinolones. In vitro studies have demonstrated high potency of ozenoxacin against staphylococci and streptococci including resistant strains of S. aureus. Clinical trials of ozenoxacin in patients with impetigo reported high clinical and microbiological success rates. Preserving the activity and availability of ozenoxacin through antimicrobial stewardship is paramount.

Topics: Aminopyridines; Animals; Anti-Bacterial Agents; Child; Drug Resistance, Bacterial; Humans; Impetigo; Quinolones; Staphylococcus aureus; Treatment Outcome

Background: Impetigo, a bacterial infection that is highly contagious, involves the superficial skin. Topical treatment for impetigo includes amongst other bacitracin, gentamycin, mupirocin, retapamulin, and more recently, ozenoxacin 1% cream. For more severe conditions systemic antibiotics are prescribed and may be combined with a topical treatment. The current review explored the challenges in treating impetigo in pediatric and adult populations and examined the role of ozenoxacin 1% cream as a safe and effective treatment option.\ \ Methods: We performed PubMed and Google Scholar searches of the English-language literature (2010-2018) using the terms impetigo, bullous impetigo, non-bullous impetigo, antimicrobial and antibiotic resistance, mupirocin, retapamulin, and ozenoxacin. The selected publications were manually reviewed for additional resources.\ \ Results: Although guidelines were updated regularly, the recommended treatments have not changed much since 2014. Emerging antimicrobial resistance is a growing concern in dermatology and pediatrics. Impetigo therapy choices should consider the resistance pattern of S. aureus. Ozenoxacin 1% cream is a prescription medicine for topical treatment of impetigo in adults and children 2 months or older. Ozenoxacin has a low probability of selecting spontaneous resistant mutants in quinolone-susceptible or quinolone-resistant bacterial strains and has shown to be active against MRSA isolates. Ozenoxacin 1% cream has potent bactericidal activity and was shown to be effective and safe for the treatment of impetigo in two well-controlled Phase 3 trials.\ \ Conclusions: Resistance patterns in a wide range of pathogens against oral or topical antibiotics and antiseptics used for the treatment of dermatological conditions, such as impetigo have been observed. When making treatment decisions for impetigo MRSA and other antimicrobial resistance has to be taken into account. Ozenoxacin 1% cream offers a potent bactericidal activity and has demonstrated clinical efficacy and safety. Combined with its favorable features, such as a low dosing frequency and a 5 days treatment regimen, ozenoxacin 1% cream is an important option for the treatment of impetigo for pediatric and adult populations.\ \ J Drugs Dermatol. 2019;18(7):655-661.

Topics: Aminopyridines; Anti-Bacterial Agents; Antimicrobial Stewardship; Clinical Decision-Making; Drug Resistance, Bacterial; Humans; Impetigo; Mutation; Patient Selection; Practice Guidelines as Topic; Quinolones; Skin Cream; Staphylococcus aureus; Treatment Outcome

To review the data supporting Food and Drug Administration (FDA) labeling of ozenoxacin and evaluate its place in therapy for impetigo.. A literature search was conducted using PubMed (1966 to May 2018) and Google Scholar (2000 to May 2018) with the search terms ozenoxacin, T-3912, and GF-001001-00. Other resources included clinicaltrials.gov , the manufacturing product label, and the FDA website.. All relevant English-language data from abstracts, phase 1 to 4 studies, and review articles were included.. FDA labeling of ozenoxacin was based on 2 phase 3 studies conducted in patients 2 months of age and older. Ozenoxacin demonstrated efficacy and safety for use in bullous or nonbullous impetigo from Staphylococcus aureus or Streptococcus pyogenes as compared with placebo. The lack of systemic absorption results in minimal adverse drug reactions. Studies did not detect possible adverse events commonly associated with other quinolone antibiotics. Relevance to Patient Care and Clinical Practice: This topical quinolone has bactericidal activity against Gram-positive organisms, including methicillin-resistant Staphylococcus aureus. Ozenoxacin may have an expanded clinical role for the treatment of localized impetigo if resistance to current therapies increases significantly. However, ozenoxacin is unlikely to play a significant role in the treatment of impetigo in the foreseeable future, because of lack of direct comparative clinical efficacy data with currently recommended therapies and likely high cost.. Ozenoxacin, the first nonfluorinated quinolone, is a safe, topical treatment for impetigo in patients 2 months of age and older. Although clinical trials demonstrate efficacy compared with placebo, comparative trials to current treatment options are needed to identify its therapeutic use.

Topics: Administration, Topical; Aminopyridines; Anti-Bacterial Agents; Clinical Trials, Phase III as Topic; Female; Humans; Impetigo; Male; Methicillin-Resistant Staphylococcus aureus; Quinolones; Staphylococcus aureus; Treatment Outcome

Ozenoxacin is a topical antibiotic approved in Europe to treat non-bullous impetigo in adults and children aged ≥6 months. This analysis evaluated the efficacy and safety of ozenoxacin in paediatric patients by age group.. Pooled data for patients aged 6 months to <18 years who had participated in a phase I or in two phase III clinical trials of ozenoxacin 1% cream were analysed by age group: 0.5-<2, 2-<6, 6-<12, and 12-<18 years.. The combined population comprised 529 patients with non-bullous impetigo treated with ozenoxacin (n = 239), vehicle (n = 201), or retapamulin as internal validation control (n = 89). Studies were well matched for extent and severity of impetigo and therapeutic schedule (twice daily application for 5 days). The clinical success rate after 5 days' treatment (day 6-7, end of therapy), and microbiological success rates after 3-4 days' treatment and at the end of therapy, were significantly higher with ozenoxacin than vehicle (p < 0.0001 for all comparisons). Clinical and bacterial eradication rates were higher with ozenoxacin than vehicle in each age group. No safety concerns were identified with ozenoxacin. One (0.3%) of 327 plasma samples exceeded the lower limit of quantification for ozenoxacin, but the low concentration indicated negligible systemic absorption.. This combined analysis supports the efficacy and safety of ozenoxacin administered twice daily for 5 days. Ozenoxacin 1% cream is a new option to consider for treatment of non-bullous impetigo in children aged 6 months to <18 years.

Topics: Administration, Topical; Adolescent; Aminopyridines; Anti-Bacterial Agents; Child; Humans; Impetigo; Quinolones; Skin Cream; Treatment Outcome

Ozenoxacin, a novel topical antibacterial agent with potent bactericidal activity against gram-positive bacteria, has been developed as a cream with 1% active drug for the treatment of impetigo, a highly contagious bacterial skin infection.. To evaluate the efficacy, safety, and tolerability of ozenoxacin cream, 1%, after 5-day twice-daily topical treatment in patients with impetigo.. This randomized, double-blind, vehicle-controlled clinical trial included patients 2 months or older with impetigo who were enrolled at centers in 6 countries from June 2, 2014, through May 30, 2015. Data were analyzed based on intention to treat from July 9 through July 22, 2015.. Patients were randomized 1:1 to receive topical ozenoxacin or placebo control.. Efficacy was measured using the Skin Infection Rating Scale and microbiological culture. Safety and tolerability were also evaluated.. Among the 411 patients who received treatment (210 males [51.1%]; mean [SD] age, 18.6 [18.3] years), ozenoxacin demonstrated superior clinical success compared with placebo, which was evident after 5 days of therapy (112 of 206 [54.4%] vs 78 of 206 [37.9%]; P = .001). Ozenoxacin also demonstrated superior microbiological success compared with placebo after 2 days of therapy (109 of 125 [87.2%] vs 76 of 119 [63.9%]; P = .002). Ozenoxacin was well tolerated, with 8 of 206 patients experiencing adverse effects, with only 1 of these potentially related to the study treatment; none were serious.. Topical ozenoxacin is effective and well tolerated in the treatment of impetigo in patients 2 months and older. This effect is demonstrated by rapid onset of response and superior clinical and microbiological response compared with placebo. Topical ozenoxacin represents a novel option for the treatment of impetigo.. ClinicalTrials.gov Identifier: NCT02090764.

Topics: Adolescent; Adult; Aminopyridines; Anti-Bacterial Agents; Child; Child, Preschool; Double-Blind Method; Drug Resistance, Bacterial; Female; Humans; Impetigo; Infant; Male; Quinolones; Skin Cream; Staphylococcal Infections; Streptococcal Infections; Streptococcus pyogenes; Young Adult

Ozenoxacin is a novel topical antibacterial agent with potent bactericidal activity against Gram-positive bacteria that has been developed as a 1% cream for treatment of impetigo. This article presents pooled results of pivotal clinical trials of ozenoxacin with the objective of evaluating the efficacy, safety, and tolerability of ozenoxacin 1% cream after twice-daily topical treatment for 5 days in patients with impetigo. A pooled analysis was performed of individual patient data from two multicenter, randomized, double-blind, vehicle-controlled phase 3 registration studies conducted in patients with impetigo. Both clinical trials followed a similar methodology. Patients were randomized 1:1 to ozenoxacin or vehicle. One trial included retapamulin as an internal control. Efficacy was measured using the Skin Infection Rating Scale and microbiological culture. Safety and tolerability were evaluated. Ozenoxacin demonstrated superior clinical success versus vehicle after 5 days of therapy, superior microbiological success versus vehicle after 2 days of therapy, and was safe and well-tolerated. Ozenoxacin showed superior clinical and microbiological response versus vehicle in children as young as 2 months of age, and adults, with impetigo. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT01397461 and NCT02090764; European Clinical Trials Database Number: 2011-003032-31 and 2014-000228-52. J Drugs Dermatol. 2018;17(10):1051-1057.

Topics: Administration, Cutaneous; Adolescent; Adult; Aged; Aminopyridines; Anti-Bacterial Agents; Child; Child, Preschool; Double-Blind Method; Drug Administration Schedule; Europe; Female; Humans; Impetigo; Infant; Male; Middle Aged; Quinolones; Randomized Controlled Trials as Topic; Russia; Severity of Illness Index; South Africa; Treatment Outcome; United States; Young Adult

In this Phase I open-label study, the systemic absorption, clinical response, safety and tolerability of multiple-dose ozenoxacin 1% cream were evaluated in children (≥ 2 months of age) and adults with impetigo. A single (evening) dose of ozenoxacin 1% cream on day 1 was followed by twice-daily application for 4 days (every 12 h), and then a final single (morning) dose on day 6. A total of 46 patients were enrolled in the study. The majority of ozenoxacin plasma samples were below the limit of quantification (no systemic absorption). Approximately half (22/45) of the evaluable patients achieved clinical success (skin lesions were cured). No patients were withdrawn from the study because of a lack of healing or worsening of a lesion. Ozenoxacin was well tolerated in all patients.

Topics: Administration, Topical; Adolescent; Adult; Aminopyridines; Anti-Bacterial Agents; Dose-Response Relationship, Drug; Drug Administration Schedule; Erythema; Female; Humans; Impetigo; Male; Middle Aged; Pruritus; Quinolones; Young Adult

We compared the efficacy and safety of ozenoxacin (a new nonfluorinated quinolone) 1% cream with placebo in the treatment of impetigo.. In a randomized, double-blind, multicenter study, patients received ozenoxacin cream or placebo cream twice daily for 5 days (a third group received retapamulin 1% ointment as a control). Clinical, microbiological and laboratory evaluations were performed during follow-up (over 2 weeks).. Ozenoxacin was superior to placebo (success rate 34.8 vs 19.2%; p = 0.003). Microbiological success was 70.8% for ozenoxacin and 38.2% for placebo after 3-4 days and 79.2% versus 56.6% after 6-7 days. Ozenoxacin produced more rapid microbiological clearance than retapamulin. All treatments were well tolerated.. Ozenoxacin 1% cream was effective and safe in the treatment of impetigo.

Topics: Adolescent; Aminopyridines; Anti-Bacterial Agents; Bridged Bicyclo Compounds, Heterocyclic; Child; Child, Preschool; Diterpenes; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Impetigo; Male; Ointments; Quinolones

Ozenoxacin is a new antibiotic used to treat non-bullous impetigo. The aim of this study is to evaluate the microbiological and clinical efficacy of topical ozenoxacin 1% cream after 5-day twice-daily treatment, in pediatric patients with impetigo.. This observational and prospective study included patients aged 6 months to 18 years, with non-bullous impetigo. Efficacy was measured using the Skin Infection Rating Scale (SIRS) and microbiological culture at the first visit (T0), at the second visit after 72 hours (T1) and after 5 days (T2). Safety and tolerability were also evaluated.. A total of 50 patients was enrolled. A reduction of SIRS score >10% after 72 hours of treatment was noticed in all patients, while a complete reduction was assessed after 5 days in all the population. Microbiologic success rates for ozenoxacin at T1 was 92% (four patients had original pathogens in the specimen culture from the skin area), whereas at T2, it was 100%.. Topical ozenoxacin has strong efficacy in treating impetigo in pediatric patients. Ozenoxacin's clinical and microbiological rapid onset of response led to consider this antibiotic a novel efficacy option for the treatment of impetigo.

Topics: Anti-Bacterial Agents; Child; Humans; Impetigo; Prospective Studies; Systemic Inflammatory Response Syndrome

Topics: Administration, Cutaneous; Aminopyridines; Anti-Bacterial Agents; Humans; Impetigo; Quinolones; Skin Cream

Topics: Aminopyridines; Animals; Anti-Bacterial Agents; Child; Disease Models, Animal; Dogs; Humans; Impetigo; Quinolones; Rats; Staphylococcal Infections; Staphylococcus aureus; Streptococcal Infections; Streptococcus pyogenes

To assess different concentrations and formulations of topical ozenoxacin using a mouse model of Staphylococcus aureus dermal infection for identification of the best formulation for treating patients with impetigo.. The efficacy of ozenoxacin formulations was compared with vehicle control, mupirocin and retapamulin ointments in a mouse model.. The most effective concentrations of ozenoxacin for reducing S. aureus counts after dermal application were 1 and 2%. Direct comparison of two batches of 1% ozenoxacin ointment and cream with 1% retapamulin and 2% mupirocin ointments in the mouse model showed superior efficacy of ozenoxacin.. 1% ozenoxacin ointment and cream were the most effective formulations in significantly reducing bacterial load in S. aureus dermally infected mice.

Topics: Administration, Topical; Aminopyridines; Animals; Animals, Outbred Strains; Anti-Bacterial Agents; Bridged Bicyclo Compounds, Heterocyclic; Disease Models, Animal; Diterpenes; Dose-Response Relationship, Drug; Humans; Impetigo; Mice; Mupirocin; Ointments; Quinolones; Skin Cream; Staphylococcus aureus; Treatment Outcome; Wound Infection

To compare the in vitro activity of the anti-impetigo agent, ozenoxacin, and other antimicrobial agents against Gram-positive clinical isolates from skin and soft tissue infections.. Isolates were collected in two studies: 1097 isolates from 49 centers during 2009-2010 and 1031 isolates from ten centers during 2014. Minimum inhibitory concentrations were determined for 18 and 11 antimicrobials in these studies, respectively, using standard broth microdilution methods. Isolates were stratified by species and methicillin susceptibility/resistance and/or levofloxacin susceptibility/nonsusceptibility status.. Ozenoxacin exhibited high in vitro activity against Staphylococcus aureus and coagulase-negative staphylococci isolates in both studies. Ozenoxacin was also highly active against Streptococcus pyogenes and Streptococcus agalactiae isolates.. Ozenoxacin is a potent antimicrobial agent against staphylococci and streptococci.

Topics: Aminopyridines; Anti-Bacterial Agents; Humans; Impetigo; Levofloxacin; Methicillin; Methicillin Resistance; Microbial Sensitivity Tests; Quinolones; Staphylococcaceae; Staphylococcus aureus; Streptococcus agalactiae; Streptococcus pyogenes