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Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes.

Morris TW, Gearinger LS, Usner DW, Paterno MR, Decory HH, Comstock TL, Haas W - Clin Ophthalmol (2011)

Bottom Line: Visit 2 (day 4 or 5) and visit 3 (day 8) overall microbiological eradication rates were 92.2% and 88.4% for besifloxacin ophthalmic suspension compared with 61.4% and 72.5% for vehicle and 91.6% and 85.7% for moxifloxacin ophthalmic solution.Eradication failures in the besifloxacin treatment group were not associated with lower antimicrobial susceptibility at baseline.The few eradication failures were not due to fluoroquinolone resistance at baseline and/or resistance development during treatment.

View Article: PubMed Central - PubMed

Affiliation: Microbiology and Sterilization Sciences, Bausch & Lomb, Rochester, NY, USA. timothy.w.morris@bausch.com

ABSTRACT

Purpose: To assess clinical antimicrobial efficacy results obtained with besifloxacin ophthalmic suspension, 0.6%, administered three times a day (TID) for 5 days, integrated across three clinical trials of bacterial conjunctivitis and to investigate any microbiological eradication failures.

Methods: Clinical microbiological eradication data from three randomized, double-masked, parallel group studies of patients with bacterial conjunctivitis (two vehicle controlled; one active controlled with moxifloxacin ophthalmic solution, 0.5%) were integrated. All bacterial samples isolated at baseline above the species-specific threshold value were subjected to antimicrobial susceptibility testing. Samples isolated at subsequent visits were subjected to susceptibility testing and pulsed-field gel electrophoresis (PFGE) to investigate the cause of eradication failures and the potential for drug resistance development.

Results: Visit 2 (day 4 or 5) and visit 3 (day 8) overall microbiological eradication rates were 92.2% and 88.4% for besifloxacin ophthalmic suspension compared with 61.4% and 72.5% for vehicle and 91.6% and 85.7% for moxifloxacin ophthalmic solution. Visit 2 and visit 3 microbiological eradication rates for Gram-positive and Gram-negative isolates and for individual species were consistent with the overall eradication rates. The majority of observed eradication failures in any treatment group were due to the persistence of the pathogen isolated at baseline. Eradication failures in the besifloxacin treatment group were not associated with lower antimicrobial susceptibility at baseline. PFGE data showed that the majority of bacterial strains in eyes with eradication failures were identical to the strain isolated at baseline; these eradication failures were not associated with a lower antimicrobial susceptibility at the follow-up visit.

Conclusion: Treatment with besifloxacin ophthalmic suspension, 0.6%, administered TID for 5 days resulted in microbiological eradication rates that were ≥ 90% across the three clinical studies for the common pathogens of bacterial conjunctivitis. The few eradication failures were not due to fluoroquinolone resistance at baseline and/or resistance development during treatment.

No MeSH data available.


Related in: MedlinePlus

Fold-increase or decrease in MIC relative to baseline for concordant isolate pairs from eyes with microbiological eradication failures across the three studies.Abbreviation: MIC, minimum inhibitory concentration.
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f4-opth-5-1359: Fold-increase or decrease in MIC relative to baseline for concordant isolate pairs from eyes with microbiological eradication failures across the three studies.Abbreviation: MIC, minimum inhibitory concentration.

Mentions: Figure 4 presents the change in MIC relative to baseline MIC within genetically concordant isolate pairs from eyes with microbiological eradication failures following active treatment. None of the concordant isolate pairs in the besifloxacin or moxifloxacin treatment groups showed an increase in MIC for besifloxacin or moxifloxacin that was greater than a single twofold dilution, indicating that none of the microbiological failures resulted from development of fluoroquinolone resistance during the treatment period.


Integrated analysis of three bacterial conjunctivitis trials of besifloxacin ophthalmic suspension, 0.6%: microbiological eradication outcomes.

Morris TW, Gearinger LS, Usner DW, Paterno MR, Decory HH, Comstock TL, Haas W - Clin Ophthalmol (2011)

Fold-increase or decrease in MIC relative to baseline for concordant isolate pairs from eyes with microbiological eradication failures across the three studies.Abbreviation: MIC, minimum inhibitory concentration.
© Copyright Policy
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3198409&req=5

f4-opth-5-1359: Fold-increase or decrease in MIC relative to baseline for concordant isolate pairs from eyes with microbiological eradication failures across the three studies.Abbreviation: MIC, minimum inhibitory concentration.
Mentions: Figure 4 presents the change in MIC relative to baseline MIC within genetically concordant isolate pairs from eyes with microbiological eradication failures following active treatment. None of the concordant isolate pairs in the besifloxacin or moxifloxacin treatment groups showed an increase in MIC for besifloxacin or moxifloxacin that was greater than a single twofold dilution, indicating that none of the microbiological failures resulted from development of fluoroquinolone resistance during the treatment period.

Bottom Line: Visit 2 (day 4 or 5) and visit 3 (day 8) overall microbiological eradication rates were 92.2% and 88.4% for besifloxacin ophthalmic suspension compared with 61.4% and 72.5% for vehicle and 91.6% and 85.7% for moxifloxacin ophthalmic solution.Eradication failures in the besifloxacin treatment group were not associated with lower antimicrobial susceptibility at baseline.The few eradication failures were not due to fluoroquinolone resistance at baseline and/or resistance development during treatment.

View Article: PubMed Central - PubMed

Affiliation: Microbiology and Sterilization Sciences, Bausch & Lomb, Rochester, NY, USA. timothy.w.morris@bausch.com

ABSTRACT

Purpose: To assess clinical antimicrobial efficacy results obtained with besifloxacin ophthalmic suspension, 0.6%, administered three times a day (TID) for 5 days, integrated across three clinical trials of bacterial conjunctivitis and to investigate any microbiological eradication failures.

Methods: Clinical microbiological eradication data from three randomized, double-masked, parallel group studies of patients with bacterial conjunctivitis (two vehicle controlled; one active controlled with moxifloxacin ophthalmic solution, 0.5%) were integrated. All bacterial samples isolated at baseline above the species-specific threshold value were subjected to antimicrobial susceptibility testing. Samples isolated at subsequent visits were subjected to susceptibility testing and pulsed-field gel electrophoresis (PFGE) to investigate the cause of eradication failures and the potential for drug resistance development.

Results: Visit 2 (day 4 or 5) and visit 3 (day 8) overall microbiological eradication rates were 92.2% and 88.4% for besifloxacin ophthalmic suspension compared with 61.4% and 72.5% for vehicle and 91.6% and 85.7% for moxifloxacin ophthalmic solution. Visit 2 and visit 3 microbiological eradication rates for Gram-positive and Gram-negative isolates and for individual species were consistent with the overall eradication rates. The majority of observed eradication failures in any treatment group were due to the persistence of the pathogen isolated at baseline. Eradication failures in the besifloxacin treatment group were not associated with lower antimicrobial susceptibility at baseline. PFGE data showed that the majority of bacterial strains in eyes with eradication failures were identical to the strain isolated at baseline; these eradication failures were not associated with a lower antimicrobial susceptibility at the follow-up visit.

Conclusion: Treatment with besifloxacin ophthalmic suspension, 0.6%, administered TID for 5 days resulted in microbiological eradication rates that were ≥ 90% across the three clinical studies for the common pathogens of bacterial conjunctivitis. The few eradication failures were not due to fluoroquinolone resistance at baseline and/or resistance development during treatment.

No MeSH data available.


Related in: MedlinePlus