An evaluation of safety and efficacy of nadifloxacin 1% ointment versus mupirocin 1% ointment in Indian children with skin and soft tissue infection

Abstract

Background: Although nadifloxacin has been shown to be effective in the treatment of skin & soft tissue infections (SSTI), there is a paucity of data comparing its efficacy and safety with other antibacterials, especially in Indian paediatric population. Therefore, objective of this study was to compare the safety and efficacy of nadifloxacin with mupirocin in children with SSTI.Methods: This was a single-centre, open label, randomized, parallel group, comparative study in 60 children of <12 years of age with SSTI. Test group (n=30) received nadifloxacin 1% ointment and reference group (n=30) received mupirocin 1% ointment, to be applied twice daily. Patients were followed up at day 4, 8 and 15. Efficacy of the study drugs was evaluated by clinical and bacteriological cure rate. Safety was assessed by reporting of adverse events.Results: Baseline characteristics of enrolled patients were comparable between treatment groups and all 60 patients completed the study. At Day 15, 100.0% cases among nadifloxacin group and 96.7% cases among mupirocin group achieved clinical cure (p=0.313). The most common bacteria found in culture were Gram positive cocci in both the groups (86.7% in nadifloxacin and 58.8% in mupirocin group). None of the cases in any of the groups showed bacteriological presence at day 15. No adverse event was reported in any of the treatment groups during the study duration.Conclusions: Nadifloxacin was found to be equally efficacious and safe to mupirocin in the treatment of SSTI in Indian pediatric population.

Role of topical nadifloxacin as an empirical treatment in patients with skin and soft-tissue infections in India: A review and consensus

“…• NF was found to be as efficacious as Mupirocin and Fusidic acid, though fusidic acid cream showed faster reduction of the scores at day 4. • No side effects in any of the groups Janbandhu et al (2020) [6] (<12 years age children with SSTI) Open label, randomized, comparative study (n=60)…”

“…Although there are meager studies comparing the efficacy of Nadifloxacin with other antimicrobials such as Mupirocin and Fusidic acid, they have shown promising results [6,8,[53][54][55] [Table 4a]. It was equally efficacious and as safe as Mupirocin and Fusidic acid in the treatment of SSTI in the Indian population.…”

“…[4] Larru and Gerber (2014) suggested that an increase in SSSI rates is mainly accredited to the emergence of methicillin-resistant Staphylococcus aureus (MRSA). [5] In India, there are minimal data on the prevalence of SSTIs and only few studies have been done till date [6][7][8] with one study reporting an incidence rate of 18.21/1000 person years in a tertiary care hospital in South India. [9] Topical Mupirocin and Fusidic acid are widely used in the treatment of SSTIs.…”