A non-inferiority study evaluating a new extended-release preparation of tilmicosin injected subcutaneously vs. ceftiofur administered intramammary, as dry-cow therapy in Holstein Friesian cows.

BACKGROUND

A new, extended long-acting tilmicosin (TLAe) preparation was tested against intramammary ceftiofur (CEF) using a non-inferiority trial model during dry-cow therapy (DCT) in a farm with high bovine population density and deficient hygiene application.

OBJECTIVES

To evaluate the possibility that TLAe administered parenterally can achieve non-inferiority status compared to CEF administered intramammary for DCT.

METHODS

Cows were randomly assigned to TLAe (20 mg/kg subcutaneous; n = 53) or CEF (CEF-HCl, 125 mg/quarter; n = 38 cows) treatment groups. California mastitis testing, colony-forming unit assessment (CFU/mL), and number of cases positive for were quantified before DCT and 7 d after calving. A complete cure was defined as no bacteria isolated; partial cure when CFU/mL ranged from 150 to 700, and cure-failure when CFU/mL was above 700.

RESULTS

TLAe and CEF had overall cure rates of 57% and 53% ( > 0.05) and cure rates of 77.7% and 25%, respectively ( < 0.05). The pathogens detected at DCT and 7 days after calving were (62.71% and 35.55%), spp. (22.03% and 35.55%), (10.16% and 13.33%), and (5.08% and 15.55%). Non-inferiority and binary logistic regression analyses revealed a lack of difference in overall efficacies of TLAe and CEF. Apart from , was the predominant pathogen found in both groups.

CONCLUSIONS

This study is the first successful report of parenteral DCT showing comparable efficacy as CEF, the gold-standard. The extended long-term pharmacokinetic activity of TLAe explains these results.