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Comparative efficacy and safety of oral fleroxacin and amoxicillin/clavulanate potassium in skin and soft tissue infections.
Am J Med. 1993 Mar 22; 94(3A):159S-165S.AJ

Abstract

The objective of this open-label, randomized, multicenter study was to compare the efficacy and safety of fleroxacin, 400 mg administered orally once daily, and amoxicillin/clavulanate potassium (AMX/CP), 500 mg/125 mg administered orally three times daily, for 4-21 days to patients with skin and soft tissue infections (SSTIs). The specific diagnoses in both groups were primarily skin abscess, impetigo, and skin ulcer, as well as wound infection erysipelas, folliculitis, cellulitis, and lymphangitis. A total of 285 patients were randomized to treatment in a 2:1 ratio, 190 in the fleroxacin group and 95 in the AMX/CP group. Adult male or female inpatients or outpatients were included in the trial and were followed up after 3-5 days of therapy and 3-9 days after completion of therapy for assessment of bacteriologic, clinical, and safety parameters. The most frequently isolated pathogen in both treatment groups was Staphylococcus aureus. Bacteriologic cures were observed in 87 (76%) of 115 evaluable patients in the fleroxacin group and in 41 (72%) of 57 evaluable patients in the AMX/CP group. Clinical cure was seen in 86 (75%) of 114 patients in the fleroxacin group and 45 (79%) of 57 patients in the AMX/CP group. Clinical adverse events related to the trial medication were reported by 40 (21%) of 189 patients in the fleroxacin group and by 16 (17%) of 95 patients in the AMX/CP group. In both groups, most adverse events were mild or moderate in severity and involved the digestive system (primarily diarrhea, nausea, and vomiting). In the fleroxacin group, adverse events affecting the central nervous system (mainly dizziness, insomnia, somnolence) also were reported. In this study, both fleroxacin and amoxicillin/clavulanate potassium were effective and well tolerated in the treatment of skin and soft tissue infections.

Authors+Show Affiliations

Department of Surgery, City Hospital, Dortmund, Germany.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial

Language

eng

PubMed ID

8452174

Citation

Tassler, H. "Comparative Efficacy and Safety of Oral Fleroxacin and Amoxicillin/clavulanate Potassium in Skin and Soft Tissue Infections." The American Journal of Medicine, vol. 94, no. 3A, 1993, 159S-165S.
Tassler H. Comparative efficacy and safety of oral fleroxacin and amoxicillin/clavulanate potassium in skin and soft tissue infections. Am J Med. 1993;94(3A):159S-165S.
Tassler, H. (1993). Comparative efficacy and safety of oral fleroxacin and amoxicillin/clavulanate potassium in skin and soft tissue infections. The American Journal of Medicine, 94(3A), 159S-165S.
Tassler H. Comparative Efficacy and Safety of Oral Fleroxacin and Amoxicillin/clavulanate Potassium in Skin and Soft Tissue Infections. Am J Med. 1993 Mar 22;94(3A):159S-165S. PubMed PMID: 8452174.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparative efficacy and safety of oral fleroxacin and amoxicillin/clavulanate potassium in skin and soft tissue infections. A1 - Tassler,H, PY - 1993/3/22/pubmed PY - 1993/3/22/medline PY - 1993/3/22/entrez SP - 159S EP - 165S JF - The American journal of medicine JO - Am J Med VL - 94 IS - 3A N2 - The objective of this open-label, randomized, multicenter study was to compare the efficacy and safety of fleroxacin, 400 mg administered orally once daily, and amoxicillin/clavulanate potassium (AMX/CP), 500 mg/125 mg administered orally three times daily, for 4-21 days to patients with skin and soft tissue infections (SSTIs). The specific diagnoses in both groups were primarily skin abscess, impetigo, and skin ulcer, as well as wound infection erysipelas, folliculitis, cellulitis, and lymphangitis. A total of 285 patients were randomized to treatment in a 2:1 ratio, 190 in the fleroxacin group and 95 in the AMX/CP group. Adult male or female inpatients or outpatients were included in the trial and were followed up after 3-5 days of therapy and 3-9 days after completion of therapy for assessment of bacteriologic, clinical, and safety parameters. The most frequently isolated pathogen in both treatment groups was Staphylococcus aureus. Bacteriologic cures were observed in 87 (76%) of 115 evaluable patients in the fleroxacin group and in 41 (72%) of 57 evaluable patients in the AMX/CP group. Clinical cure was seen in 86 (75%) of 114 patients in the fleroxacin group and 45 (79%) of 57 patients in the AMX/CP group. Clinical adverse events related to the trial medication were reported by 40 (21%) of 189 patients in the fleroxacin group and by 16 (17%) of 95 patients in the AMX/CP group. In both groups, most adverse events were mild or moderate in severity and involved the digestive system (primarily diarrhea, nausea, and vomiting). In the fleroxacin group, adverse events affecting the central nervous system (mainly dizziness, insomnia, somnolence) also were reported. In this study, both fleroxacin and amoxicillin/clavulanate potassium were effective and well tolerated in the treatment of skin and soft tissue infections. SN - 0002-9343 UR - https://www.unboundmedicine.com/medline/citation/8452174/Comparative_efficacy_and_safety_of_oral_fleroxacin_and_amoxicillin/clavulanate_potassium_in_skin_and_soft_tissue_infections_ L2 - https://medlineplus.gov/bacterialinfections.html DB - PRIME DP - Unbound Medicine ER -