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Open trial of oral fleroxacin versus amoxicillin/clavulanate in the treatment of infections of skin and soft tissue.
Am J Med. 1993 Mar 22; 94(3A):155S-158S.AJ

Abstract

In a multicenter, prospective, randomized trial, fleroxacin was compared with amoxicillin/clavulanate potassium (AMX/CP) for the treatment of infections of skin and soft tissue. Fleroxacin was given at a dosage of 400 mg once daily, and AMX/CP was given at a dosage of 500 mg/125 mg three times a day. Each was administered for 4-21 days. Adult patients with the clinical diagnosis of skin or soft tissue infections were eligible for enrollment. Patients were randomized in a 2:1 ratio. A total of 191 patients were enrolled; 126 took fleroxacin, and 65 took AMX/CP. Of these patients, 42 in the fleroxacin group and 26 in the AMX/CP group were evaluable for both clinical and bacteriologic efficacies. Patients with abscesses comprised the largest single category in each group. Principle reasons for exclusion included: patients lost to follow-up (17 [13%] fleroxacin, 12 [18%] AMX/CP); failure to isolate a causative pathogen (19 [15%] fleroxacin, 9 [14%] AMX/CP); and resistance to study drug (11 [9%] fleroxacin, 2 [3%] AMX/CP). Staphylococcus aureus was the most commonly isolated pathogen. Streptococcus group A, Staphylococcus coagulase-negative, Escherichia coli, and Proteus species, in decreasing order, were the next most common pathogens. Clinical and bacteriologic efficacy was excellent in both groups, with a cure rate of > or = 90%. There were two bacteriologic failures in each group. Patients taking fleroxacin complained of slightly more adverse events, which involved primarily the digestive and central nervous systems. The rate of withdrawal from the study because of adverse events was 4% in both groups. Fleroxacin, 400 mg given once daily, is safe and as effective as AMX/CP in the treatment of skin and soft tissue infections in adults.

Authors+Show Affiliations

Emergency Medical Services, University of Virginia Health Sciences Center, Charlottesville.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

8452173

Citation

Powers, R D.. "Open Trial of Oral Fleroxacin Versus Amoxicillin/clavulanate in the Treatment of Infections of Skin and Soft Tissue." The American Journal of Medicine, vol. 94, no. 3A, 1993, 155S-158S.
Powers RD. Open trial of oral fleroxacin versus amoxicillin/clavulanate in the treatment of infections of skin and soft tissue. Am J Med. 1993;94(3A):155S-158S.
Powers, R. D. (1993). Open trial of oral fleroxacin versus amoxicillin/clavulanate in the treatment of infections of skin and soft tissue. The American Journal of Medicine, 94(3A), 155S-158S.
Powers RD. Open Trial of Oral Fleroxacin Versus Amoxicillin/clavulanate in the Treatment of Infections of Skin and Soft Tissue. Am J Med. 1993 Mar 22;94(3A):155S-158S. PubMed PMID: 8452173.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Open trial of oral fleroxacin versus amoxicillin/clavulanate in the treatment of infections of skin and soft tissue. A1 - Powers,R D, PY - 1993/3/22/pubmed PY - 1993/3/22/medline PY - 1993/3/22/entrez SP - 155S EP - 158S JF - The American journal of medicine JO - Am J Med VL - 94 IS - 3A N2 - In a multicenter, prospective, randomized trial, fleroxacin was compared with amoxicillin/clavulanate potassium (AMX/CP) for the treatment of infections of skin and soft tissue. Fleroxacin was given at a dosage of 400 mg once daily, and AMX/CP was given at a dosage of 500 mg/125 mg three times a day. Each was administered for 4-21 days. Adult patients with the clinical diagnosis of skin or soft tissue infections were eligible for enrollment. Patients were randomized in a 2:1 ratio. A total of 191 patients were enrolled; 126 took fleroxacin, and 65 took AMX/CP. Of these patients, 42 in the fleroxacin group and 26 in the AMX/CP group were evaluable for both clinical and bacteriologic efficacies. Patients with abscesses comprised the largest single category in each group. Principle reasons for exclusion included: patients lost to follow-up (17 [13%] fleroxacin, 12 [18%] AMX/CP); failure to isolate a causative pathogen (19 [15%] fleroxacin, 9 [14%] AMX/CP); and resistance to study drug (11 [9%] fleroxacin, 2 [3%] AMX/CP). Staphylococcus aureus was the most commonly isolated pathogen. Streptococcus group A, Staphylococcus coagulase-negative, Escherichia coli, and Proteus species, in decreasing order, were the next most common pathogens. Clinical and bacteriologic efficacy was excellent in both groups, with a cure rate of > or = 90%. There were two bacteriologic failures in each group. Patients taking fleroxacin complained of slightly more adverse events, which involved primarily the digestive and central nervous systems. The rate of withdrawal from the study because of adverse events was 4% in both groups. Fleroxacin, 400 mg given once daily, is safe and as effective as AMX/CP in the treatment of skin and soft tissue infections in adults. SN - 0002-9343 UR - https://www.unboundmedicine.com/medline/citation/8452173/Open_trial_of_oral_fleroxacin_versus_amoxicillin/clavulanate_in_the_treatment_of_infections_of_skin_and_soft_tissue_ L2 - https://medlineplus.gov/bacterialinfections.html DB - PRIME DP - Unbound Medicine ER -