RESUMO
This guideline is intended as an aid in the design, implementation and interpretation of studies for the assessment of drug efficacy against Eimeria in cattle and sheep, Cystoisospora in pigs and dogs, and Cryptosporidium in cattle. It deals with the most important aspects of how to conduct both experimental and field studies for dose determination, dose confirmation and assessment of field effectiveness. Also, guidance on the selection of animals, diagnostic techniques, statistical evaluation and methods for the preparation, maintenance and use of parasites is provided. The specific management conditions that may influence the course of natural infections and consequently determine treatment schemes are mentioned and suggestions for best practice in sampling and evaluation of data prior to conducting of efficacy studies are given. The guideline is also intended to assist investigators in carrying out specific studies, provide relevant information for registration authorities involved in the decision-making process, assist in the approval of anticoccidial drugs in the target species, and facilitate the world-wide adoption of standard procedures. Although currently not implemented, issues of drug resistance testing and alternative methods for drug testing are also discussed as future issues in drug testing against mammalian coccidia.
Assuntos
Coccídios/efeitos dos fármacos , Coccidiose/veterinária , Coccidiostáticos/uso terapêutico , Guias como Assunto , Animais , Bovinos , Coccidiose/tratamento farmacológico , Coccidiose/parasitologia , Cães , Avaliação de Medicamentos/veterinária , Ovinos , Suínos , Medicina VeterináriaRESUMO
For reliable predictions of clinical and parasitological outcome of experimental infections with parasites, different models must be evaluated for possible influences of infection time point, infection dose and host-specific parameters such as breed or litter size. To address these issues for Cystoisospora (syn. Isospora) suis, the causative agent of porcine neonatal coccidiosis, 181 piglets from 90 litters (hybrid crosses of different breeds) were included in a retrospective study to evaluate differences in time point and dose of infection in four different experimental models ((1) 1,500 oocysts on the 4th day of life, d.o.l.; (2) 1,000 oocysts, 4th d.o.l.; (3) 1,000 oocysts, 1st d.o.l.; (4) 5,000 oocysts, 4th d.o.l.). The target variables body weight gain, faecal consistency and oocyst excretion were evaluated during the acute phase of infection (5-10 days post infection), and the influences of the dependent variables breed or litter size were estimated. Despite differences in the time course of excretion and faecal consistency, neither the average amount of excretion nor the average faecal consistency differed among models, breeds or litters of different size. High individual variability was seen in all four models as described earlier for higher infection doses. When infections on the 1st vs. 4th day of life were compared, no differences in averages could be found, in contrast to previous observations on the influence of age. Other, not yet defined, variables appear to have a greater impact on the outcome of infection than doses and time points in the tested range, despite the reliable outcome of infection with high excretion rates and signs of clinical disease.