Comparison of efficacy of levofloxacin-metronidazole combination versus ceftriaxone in cases of moderate diabetic foot infection

Swati V. Patil; Roshan R. Mane

doi:10.18203/2319-2003.ijbcp20163145

Authors

Swati V. Patil Department of Pharmacology, LTMMC and GH, Sion, Mumbai, Maharashtra, India
Roshan R. Mane Scientific and medical affairs, Abbott Nutrition International, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20163145

Keywords:

Diabetic foot infection, Metronidazole, Levofloxacin, Ceftriaxone

Abstract

Background: Foot ulcers are a significant complication of diabetes and are the most common cause of non-traumatic lower extremity amputations in the industrialized world. Diabetic foot infections can be treated effectively with cephalosporins and fluoroquinolnes. The purpose of this study was to compare the efficacy, safety and microbiological outcomes of ceftriaxone and combination of levofloxacin and metronidazole.

Methods: This was a prospective, open labelled, randomized controlled trial study. Patients diagnosed of having diabetic foot infection were recruited for the study from the OPD and IPD of the surgery department of Govt. Medical College and Hospital, Miraj and PVP Govt. Hospital, Sangli from June 2007 to December 2007. Signed informed consents were obtained from the patients. The study complied with declaration of Helsinki. Enrolled patients were randomized in 2 groups. Group 1: ceftriaxone group: patients were hospitalized and received ceftriaxone1 gm intravenously for 14 days. Group 2: levofloxacin and metronidazole group: patients were treated as out-patients and received Levofloxacin 500 mg orally once daily with metronidazole 400 mg orally thrice daily for 14 days. Detailed history and complete physical examination was done for all patients. Sequential measurement of the lesion was done, to assess the change in size. Bacteriological evaluation was done. Clinical and microbiological outcome and safety parameters were assessed after treatment.

Results: The baseline characteristics in both the groups were comparable and were not significant with each other (p >0.05). In both the groups the most commonly isolated aerobe was staphylococci species followed by different species of enterobacteriacae and pseudomonas. Most commonly isolated anaerobe was bacteroides fragilis. Microbiological and clinical outcomes were assessed and the total no of patients recovered in both groups were almost similar. The percentage of wound healing in both the treatment groups was equal. None of the patients in both the groups had shown complete wound healing. The number of adverse effects associated with the therapies was also similar. The cost of therapies in both the groups were assessed and found the difference was highly significant.

Conclusions: Even though combination of levofloxacin-metronidazole and ceftriaxone alone had similar outcomes in terms of efficacy, on contrary in comparison of cost and convenience, levofloxacin - metronidazole therapy was proved better than ceftriaxone in treatment of diabetic foot ulcers.

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