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Open-label assessment of levofloxacin for the treatment of acute bacterial sinusitis in adults.
Ann Allergy Asthma Immunol. 1998 Apr; 80(4):357-62.AA

Abstract

PURPOSE

To evaluate the efficacy and safety of levofloxacin (500 mg orally once daily for 10 to 14 days) in treating adult outpatients with acute bacterial sinusitis.

PATIENTS AND METHODS

A total of 329 patients enrolled in the study at 24 centers. All patients had a pre-therapy Gram's stain and culture of sinus exudate obtained by antral puncture or nasal endoscopy. Clinical response was assessed on the basis of signs and symptoms and sinus radiograph or computed tomography results. Microbiologic cure rates were determined on the basis of presumed plus documented eradication of the pre-therapy pathogen(s).

RESULTS

The most common pathogens were Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus, and Moraxella catarrhalis. Of 300 clinically evaluable patients, 175 (58%) were cured and 90 (30%) were improved at the post-therapy evaluation, resulting in a clinical success rate of 88%. Thirty-five patients (12%) clinically failed treatment. The microbiologic eradication rate (presumed plus documented) among 138 microbiologically evaluable patients was 92%. Microbiologic eradication rates (presumed plus documented) of the most common pathogens ranged from 93% (M. catarrhalis) to 100% (S. pneumoniae) at the post-therapy visit. All but one of the 265 patients who were cured or improved at post-therapy returned for a long-term follow-up visit; 243 (92%) remained well 4 to 6 weeks after therapy; and 21 (8%) had a relapse of symptoms. Adverse events considered to be related to levofloxacin administration were reported by 29 patients (9%). The most common drug-related adverse events were diarrhea, flatulence, and nausea; most adverse events were mild to moderate in severity.

CONCLUSION

The results of this study indicate that levofloxacin 500 mg once daily is an effective and safe treatment for acute bacterial sinusitis.

Authors+Show Affiliations

Virginia Medical Studies Group, Charlottesville, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

9564988

Citation

Sydnor, T A., et al. "Open-label Assessment of Levofloxacin for the Treatment of Acute Bacterial Sinusitis in Adults." Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, vol. 80, no. 4, 1998, pp. 357-62.
Sydnor TA, Kopp EJ, Anthony KE, et al. Open-label assessment of levofloxacin for the treatment of acute bacterial sinusitis in adults. Ann Allergy Asthma Immunol. 1998;80(4):357-62.
Sydnor, T. A., Kopp, E. J., Anthony, K. E., LoCoco, J. M., Kim, S. S., & Fowler, C. L. (1998). Open-label assessment of levofloxacin for the treatment of acute bacterial sinusitis in adults. Annals of Allergy, Asthma & Immunology : Official Publication of the American College of Allergy, Asthma, & Immunology, 80(4), 357-62.
Sydnor TA, et al. Open-label Assessment of Levofloxacin for the Treatment of Acute Bacterial Sinusitis in Adults. Ann Allergy Asthma Immunol. 1998;80(4):357-62. PubMed PMID: 9564988.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Open-label assessment of levofloxacin for the treatment of acute bacterial sinusitis in adults. AU - Sydnor,T A, AU - Kopp,E J, AU - Anthony,K E, AU - LoCoco,J M, AU - Kim,S S, AU - Fowler,C L, PY - 1998/5/16/pubmed PY - 1998/5/16/medline PY - 1998/5/16/entrez SP - 357 EP - 62 JF - Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology JO - Ann Allergy Asthma Immunol VL - 80 IS - 4 N2 - PURPOSE: To evaluate the efficacy and safety of levofloxacin (500 mg orally once daily for 10 to 14 days) in treating adult outpatients with acute bacterial sinusitis. PATIENTS AND METHODS: A total of 329 patients enrolled in the study at 24 centers. All patients had a pre-therapy Gram's stain and culture of sinus exudate obtained by antral puncture or nasal endoscopy. Clinical response was assessed on the basis of signs and symptoms and sinus radiograph or computed tomography results. Microbiologic cure rates were determined on the basis of presumed plus documented eradication of the pre-therapy pathogen(s). RESULTS: The most common pathogens were Haemophilus influenzae, Streptococcus pneumoniae, Staphylococcus aureus, and Moraxella catarrhalis. Of 300 clinically evaluable patients, 175 (58%) were cured and 90 (30%) were improved at the post-therapy evaluation, resulting in a clinical success rate of 88%. Thirty-five patients (12%) clinically failed treatment. The microbiologic eradication rate (presumed plus documented) among 138 microbiologically evaluable patients was 92%. Microbiologic eradication rates (presumed plus documented) of the most common pathogens ranged from 93% (M. catarrhalis) to 100% (S. pneumoniae) at the post-therapy visit. All but one of the 265 patients who were cured or improved at post-therapy returned for a long-term follow-up visit; 243 (92%) remained well 4 to 6 weeks after therapy; and 21 (8%) had a relapse of symptoms. Adverse events considered to be related to levofloxacin administration were reported by 29 patients (9%). The most common drug-related adverse events were diarrhea, flatulence, and nausea; most adverse events were mild to moderate in severity. CONCLUSION: The results of this study indicate that levofloxacin 500 mg once daily is an effective and safe treatment for acute bacterial sinusitis. SN - 1081-1206 UR - https://www.unboundmedicine.com/medline/citation/9564988/Open_label_assessment_of_levofloxacin_for_the_treatment_of_acute_bacterial_sinusitis_in_adults_ DB - PRIME DP - Unbound Medicine ER -