Efficacy and tolerability of cefditoren pivoxil in uncomplicated skin and skin structure infections in Indian patients

Charu Manaktala; Amit Kumar Singh; Manish Verma; Asheesh Sachdeva; Himanshu Sharma; Arjun Roy; RK Jalali; R Gowrishankar; A Kumar; A Sainath Kumar; AM Jayaraman; B Swarnkar; CR Srinivas; Chitra Nayak; D Duttaroy; D Umrigar; Madhuri Jesudanam; N Maheshwari; P Shetty; RP Singh; S Ghate; S Sacchidanand; S Tolat; Salman Bhoira; Y Marfatia

doi:10.4103/0019-5154.57612

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Year : 2009 | Volume : 54 | Issue : 4 | Page : 350-356

Efficacy and tolerability of cefditoren pivoxil in uncomplicated skin and skin structure infections in Indian patients

Charu Manaktala¹, Amit Kumar Singh¹, Manish Verma¹, Asheesh Sachdeva¹, Himanshu Sharma¹, Arjun Roy¹, RK Jalali¹, R Gowrishankar¹, A Kumar², A Sainath Kumar³, AM Jayaraman⁴, B Swarnkar⁵, CR Srinivas⁶, Chitra Nayak⁷, D Duttaroy⁸, D Umrigar⁹, Madhuri Jesudanam¹⁰, N Maheshwari¹¹, P Shetty¹², RP Singh¹³, S Ghate¹⁴, S Sacchidanand¹⁵, S Tolat¹⁶, Salman Bhoira¹⁷, Y Marfatia¹⁸
¹ Medical Affairs and Clinical Research, Ranbaxy Laboratories Ltd, 77-B, IFFCO Road, Sector-18, Udyog Vihar Industrial Area, Gurgaon, Haryana, India
² Department of Dermatology, Kamineni Institute of Medical Sciences, Naketpally, Nalgonda, India
³ Princess Esra Hospital, Hyderabad, India
⁴ Department of Dermatology, Stanley Govt Hospital, Chennai, India
⁵ Anand Bazar Main Road, Indore, India
⁶ Department of Dermatology, PSG Hospitals, Coimbatore, India
⁷ BYL Nair Charitable Hospital & TNMC, Mumbai, India
⁸ Department of Surgery, Govt. Medical College & Shri Sayajirao General Hospital, Vadodara, India
⁹ Department of Dermatology and STD, GMC and New Civil Hospital, Surat, India
¹⁰ Flora Apartments, Besides Almond House, Road No. 3, Banjara Hills, Hyderabad, India
¹¹ Hari Clinic, 3/95, Kamal Kunj, Vikas Nagar, Lucknow, India
¹² Raghu Skin Clinic, Suvarna Complex, Karver Road, Kothrud, Pune, India
¹³ Department of Dermatology, Govt. Medical College, Nagpur, India
¹⁴ Foundation for Medical Research, Near Flora Dinning Restaurant, Worli Sea Face, Mumbai, India
¹⁵ Department of Skin & STD, Victoria Hospital, Bangalore Medical College, Bangalore, India
¹⁶ Skin & VD, Shangrila Garden, Bund Garden Corner, Pune, India
¹⁷ Dr. Shaukat's Nursing Home, Natawala Building, Cadell Road, Mahim (W), Mumbai, India
¹⁸ Department. of Skin & VD, Medical College & SSG Hospital, Vadodara, India

Correspondence Address:
Charu Manaktala
Medical Affairs and Clinical Research, Ranbaxy Research Laboratories, 77B, IFFCO Road, Sector 18, Udyog Vihar Industrial Area, Gurgaon, Haryana - 122 015
India

Source of Support: Ranbaxy Laboratories Ltd, India., Conflict of Interest: Cefdinir used in the study is manufactured by Ranbaxy Laboratories Ltd, one of the authors (CM) is full time employee of Ranbaxy Laboratories Ltd.

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DOI: 10.4103/0019-5154.57612

Background: Uncomplicated skin and skin structure infections (uSSSI) are commonly encountered community-acquired infections and are typically confined to the superficial layers of the skin. Hence, they seldom lead to the destruction of skin structures. Aims: To evaluate the efficacy and tolerability of cefditoren pivoxil in uSSSI in Indian patients. Methods: One hundred and seventy-eight patients diagnosed with uncomplicated SSSI were enrolled in this randomized, comparative, multicentric study. Patients received either cefditoren pivoxil or cefdinir for ten days. Efficacy was assessed both clinically and microbiologically. Safety evaluation consisted of reporting of type, frequency, severity, and causal relationship of adverse events. Results: One hundred and fifty-one patients completed the study. Clinical and bacteriological efficacy of cefditoren pivoxil was comparable to that of cefdinir in the treatment of uSSSI. One hundred and five patients were eligible for per protocol (PP) analysis of bacteriological outcome and clinical efficacy. Clinical cure or improvement was achieved in 98.00% patients treated with cefditoren pivoxil and 98.18% patients treated with cefdinir. In the modified Intent to Treat (mITT) patient population, clinical cure or improvement was recorded in 97.33% patients treated with cefditoren pivoxil and 96.20% patients treated with cefdinir. Microbiological eradication (or presumed eradication) was recorded in 88.00% patients treated with cefditoren pivoxil and 94.55% patients treated with cefdinir. The above differences in the outcome rates between the two drugs were not statistically significant. Six adverse events (AEs) (two in cefditoren group and four in cefdinir group) were reported in this study. Conclusion: Cefditoren pivoxil 200 mg b.i.d. was effective and well tolerated in the treatment of uSSSI.

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