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Moxifloxacin in complicated skin and skin structure infections (cSSSIs): A prospective, international, non-interventional, observational study.
Adv Ther. 2013 Jun; 30(6):630-43.AT

Abstract

INTRODUCTION

ARTOS was an international, prospective, non-interventional, non-controlled observational study designed to determine the effectiveness, safety, and tolerability of moxifloxacin under daily-life conditions in patients with complicated skin and skin structure infections (cSSSIs) treated in Europe, the Middle East, and Asia-Pacific region.

METHODS

Eligible patients included males and females who were hospitalized patients or outpatients requiring antibiotic therapy for cSSSIs and for whom the treating physician had elected to begin moxifloxacin therapy in accordance with its approved indications. Patients were assessed before therapy and then at one or two follow-up visits. Effectiveness was assessed with respect to improvement and resolution of signs and symptoms of cSSSIs and safety with respect to the nature and frequency of adverse events and adverse drug reactions.

RESULTS

A total of 6,594 patients were enrolled of whom 5,444 had data available for analysis; 4,692 patients received sequential intravenous/oral (IV/PO) moxifloxacin and 752 exclusively IV therapy. A majority of patients were aged between 40 and 79 years and had one or more comorbid conditions. Post-surgical wound infection, skin abscess, and diabetic foot infection were the cSSSIs most frequently diagnosed and treated with moxifloxacin, with almost 90% of infections rated moderate or severe. Treating physicians chose sequential moxifloxacin 400 mg for most patients, switching from IV to PO after 3-4 days. On average, treatment was maintained for 10 days. Treatment with moxifloxacin was associated with rapid relief in symptoms, with 93.2% of patients experiencing either complete resolution of symptoms or improvement at follow-up. Moxifloxacin was well tolerated with adverse drug reactions occurring in only 2% of patients.

CONCLUSIONS

This study, conducted in a 'real-world' setting, confirms the effectiveness and safety of moxifloxacin in the treatment of a wide spectrum of cSSSIs seen in routine clinical practice.

Authors+Show Affiliations

Infektionsabteilung Med Klinik und Poliklinik IV, University Hospital of Munich, Munich, Germany. Johannes.Bogner@med.uni-muenchen.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Observational Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23797470

Citation

Bogner, Johannes R., et al. "Moxifloxacin in Complicated Skin and Skin Structure Infections (cSSSIs): a Prospective, International, Non-interventional, Observational Study." Advances in Therapy, vol. 30, no. 6, 2013, pp. 630-43.
Bogner JR, Kutaiman A, Esguerra-Alcalen M, et al. Moxifloxacin in complicated skin and skin structure infections (cSSSIs): A prospective, international, non-interventional, observational study. Adv Ther. 2013;30(6):630-43.
Bogner, J. R., Kutaiman, A., Esguerra-Alcalen, M., Heldner, S., & Arvis, P. (2013). Moxifloxacin in complicated skin and skin structure infections (cSSSIs): A prospective, international, non-interventional, observational study. Advances in Therapy, 30(6), 630-43.
Bogner JR, et al. Moxifloxacin in Complicated Skin and Skin Structure Infections (cSSSIs): a Prospective, International, Non-interventional, Observational Study. Adv Ther. 2013;30(6):630-43. PubMed PMID: 23797470.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Moxifloxacin in complicated skin and skin structure infections (cSSSIs): A prospective, international, non-interventional, observational study. AU - Bogner,Johannes R, AU - Kutaiman,Ammar, AU - Esguerra-Alcalen,Melanie, AU - Heldner,Stephanie, AU - Arvis,Pierre, PY - 2013/02/20/received PY - 2013/6/26/entrez PY - 2013/6/26/pubmed PY - 2014/3/13/medline SP - 630 EP - 43 JF - Advances in therapy JO - Adv Ther VL - 30 IS - 6 N2 - INTRODUCTION: ARTOS was an international, prospective, non-interventional, non-controlled observational study designed to determine the effectiveness, safety, and tolerability of moxifloxacin under daily-life conditions in patients with complicated skin and skin structure infections (cSSSIs) treated in Europe, the Middle East, and Asia-Pacific region. METHODS: Eligible patients included males and females who were hospitalized patients or outpatients requiring antibiotic therapy for cSSSIs and for whom the treating physician had elected to begin moxifloxacin therapy in accordance with its approved indications. Patients were assessed before therapy and then at one or two follow-up visits. Effectiveness was assessed with respect to improvement and resolution of signs and symptoms of cSSSIs and safety with respect to the nature and frequency of adverse events and adverse drug reactions. RESULTS: A total of 6,594 patients were enrolled of whom 5,444 had data available for analysis; 4,692 patients received sequential intravenous/oral (IV/PO) moxifloxacin and 752 exclusively IV therapy. A majority of patients were aged between 40 and 79 years and had one or more comorbid conditions. Post-surgical wound infection, skin abscess, and diabetic foot infection were the cSSSIs most frequently diagnosed and treated with moxifloxacin, with almost 90% of infections rated moderate or severe. Treating physicians chose sequential moxifloxacin 400 mg for most patients, switching from IV to PO after 3-4 days. On average, treatment was maintained for 10 days. Treatment with moxifloxacin was associated with rapid relief in symptoms, with 93.2% of patients experiencing either complete resolution of symptoms or improvement at follow-up. Moxifloxacin was well tolerated with adverse drug reactions occurring in only 2% of patients. CONCLUSIONS: This study, conducted in a 'real-world' setting, confirms the effectiveness and safety of moxifloxacin in the treatment of a wide spectrum of cSSSIs seen in routine clinical practice. SN - 1865-8652 UR - https://www.unboundmedicine.com/medline/citation/23797470/Moxifloxacin_in_complicated_skin_and_skin_structure_infections__cSSSIs_:_A_prospective_international_non_interventional_observational_study_ L2 - https://dx.doi.org/10.1007/s12325-013-0038-z DB - PRIME DP - Unbound Medicine ER -