Noninferiority field trial for evaluation of efficacy of ciprofloxacin associated with internal teat sealant as dry-off protocol.

Abstract

The aim of this study was to compare the efficacy of two dry-off protocols: (a) dry cow therapy using ciprofloxacin hydrochloride 400mg followed by the administration of an internal teat sealant composed of 4g of bismuth subnitrate, and (b) a positive control using dry cow therapy with 250mg cephalonium followed by the administration of 2.6g bismuth subnitrate internal teat sealant. A total of 578 Holstein cows selected from 7 commercial herds were randomly allocated into two groups at drying off: (a) ciprofloxacin hydrochloride 400mg (CH) associated with ITS, n = 1112 mammary quarters/296 cows, or (b) positive control (PC) = cephalonium (250mg) associated with ITS, n = 1058 mammary quarters/282 cows). A total of 1787 out of 2170 mammary quarters (82%) had negative culture at drying off. The microorganisms most frequently isolated at drying off were CNS (5.62%), Strep. uberis (1.9%), Corynebacterium spp. (1.8%), and Staphylococcus aureus (1.01%). A total of 465 mammary quarters experienced new intramammary infections (NIMIs), and the main microorganisms causing NIMI were CNS (21.94%), Strep. uberis (17.2%), and Pseudomonas spp. (9.7%). The CH protocol was not inferior to PC, as the cure risk of mammary quarters CH-treated was at the noninferiority limit. However, the mammary quarters treated by CH protocol had 24% and 31% lower risk of overall NIMI and NIMI caused by major pathogens, respectively, than mammary quarters dried with the PC protocol. In addition, the mammary quarters treated with CH protocol had a lower risk of CM through the first 60 DIM than those treated with PC protocol. Both DCT protocols showed similar odds of microbiological cure, but the CH protocol had greater prevention against NIMI during dry-off period.