Recipient Organization
UNIV OF PENNSYLVANIA
(N/A)
PHILADELPHIA,PA 19104
Performing Department
School Of Veterinary Medicine
Non Technical Summary
The goal of this proposed study is to gain approval from the EMEA (the Italian equivalent of the US-FDA)for the use of oral Cephalexin Monohydrate tablets (an antibiotic) for use in dogs. To achieve this end this study seeks to investigate the target animal safety/tolerance of oral administration of Cephalexin Monohydrate tablets(500mg)at two different dosages over a period of five days in healthy dogs. This study will evaluate that Cephalexin given orally is safe and that when given at the dose of 30mg/kg twice daily it is as safe as when given at the dose of 15mg/kg twice daily in dogs over a five day period.
Animal Health Component
100%
Research Effort Categories
Basic
(N/A)
Applied
100%
Developmental
(N/A)
Goals / Objectives
The goal of this proposed study is to gain approval from the EMEA (the Italian equivalent of the US-FDA)for the use of oral Cephalexin Monohydrate tablets for use in dogs. To achieve this end this study seeks to investigate the target animal safety/tolerance of oral administration of Cephalexin Monohydrate tablets(500mg)at two different dosages over a period of five days in healthy dogs. This study will evaluate that Cephalexin given orally is safe and that when given at the dose of 30mg/kg twice daily it is as safe as when given at the dose of 15mg/kg twice daily in dogs over a five day period.
Project Methods
The study will enroll 18 healthy dogs. Dogs must be systemically healthy with no existing medical conditions that require daily oral medication. For inclusion dogs must be between the ages of 1-10 years of age and weigh between 6.5kg to 70.8kg. Owners must be willing to administer oral medication and be willing to commit to a total of three in hospital visits. Dogs will be excluded from the trial if they have a current medical condition that requires daily oral medication, have received any oral medication or has vomited in the prior 2 weeks before the initial study visit, severe periodontal disease, dog's intolerance to oral dosing, clinical signs of systemic disease, any abnormalities on the complete blood count and serum chemistry profile, any history of allergic reactions or intolerance to Cephalexin or related drugs. Once these criteria have been met then enrolled dogs will be randomized into three treatment groups containing six dogs per group (3 males/3 Females of either reproductive status). These groups will be labeled A, B, and C. Group A will be given Cephalexin at the dose of 15mg/kg twice a day with food over the course of five days. Group B will be given Cephalexin at the dose of 30mg/kg twice a day with food over the course of five days. Group C will be normal healthy controls who will not be receiving Cephalexin. The dogs will not be given any special food with the Cephalexin, they will be getting whatever food they normally eat. Dosing will be done at approximately the same time twice daily (12-14 hours apart i.e. 6am/6pm). A physical which will include a rectal temperature, heart rate and respiratory rate will be conducted at all three visits. Also all dogs will have blood drawn for a complete blood count and serum chemistry profile at day one/zero hour before first dose administration (visit one), at 72 hours (visit two) and finally at the end point of 120 hours when the last Cephalexin dose is given (visit three/final visit). The amount of blood drawn per dog will be 4 to 5mls per blood draw for a total of about 15mls per dog over the course of the study. This breaks down to about 1 teaspoon per blood draw for a total of about 1.5 tablespoons total. Cephalexin is used frequently in dogs in the United States and has been found to have few side effects. The side effects are rare and include are: hypersensitivity reactions, GI side effects (vomiting, diarrhea, anorexia), and nephrotoxicity. Any dog showing any of these rare toxicities will be withdrawn from the study and treated. Results from clinical observations, CBC and Chesmitry profiles will be analyzed by the biostatistics core group. The results obtained for every time point in individuals of all groups will be tabulated and arithmetic means and SD determined. Where relevant, the values will be statistically evaluated among the treatment groups via Analysis Of Variance (ANOVA). This study will be run according to GCP and GLP protocols.