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Prüfung der Wirksamkeit von 3 verschiedenen Dosierungen von BKI-1369 in mit Cystoisospora suis infizierten Ferkeln, die am Tag 2 nach der Infektion einmalig verabreicht werden.

Abstract
From the results of previous two in vivo trials, we can conclude that,a. single treatment with 20 mg/kg BW BKI 1369 is effective in reducing oocyst ex-cretion and diarrhea and improving body weight gain in piglets infected with C. suis, andb. single treatment with BKI 1369 2 dpi is more effective compared to treatment at the day of infection (o dpi).However, application of single drug concentration i.e, 20 mg/kg BW in both of the previ-ous trials did not allowed us to determine the minimal effective drug concentration, which is indispensable to develop practical drug application scheme. Therefore, in the upcoming animal trial, we plan to test efficacy of three different doses of BKI 1369 ap-plied per oral only once 2 dpi. The intended treatment scheme and doses are outlined below;Group No. of piglets at the beginning of the study Treatment dose Time point of treatmentA ≥8 20 mg/kg BW of BKI 1369 (5%)= 0.4 ml/kg of BW; single dose SD 5 (2 dpi)B ≥8 10 mg/kg BW of BKI 1369 (5%)= 0.4 ml/kg of BW; single dose SD 5 (2 dpi)C ≥8 5 mg/kg BW of BKI 1369 (5%)= 0.4 ml/kg of BW; single dose SD 5 (2 dpi)D ≥8 Solvent (3% + 7% ethanol + 90% normal saline); single dose SD 5 (2 dpi)This trial will include three sows and their litters in one experimental site. The trial will last for 29 days and the first day of study (SD1) will be the first day after birth of the pig-lets.Assessment of efficacy and safety1. Fecal samples will be collected and fecal consistency will be scored daily from SD 7 to SD 27.2. Oocyst counts will be performed for each individual sample from SD 7 to SD 27 using autofluorescence and for positive samples, by a modified McMaster method.3. Pooled fecal samples from each litter on SD 7 will be sent to laboratory (Microbiology and Virology, Vetmeduni Vienna) to determine other possible causes of diarrhea.4. Each piglet will be weighed on the day of birth and then weekly until SD 29.5. Piglets will be observed by a veterinarian during and 2 h after treatment in addi-tion to general health observation to evaluate any drug-related adverse events.6. If applicable, pooled fecal samples will be collected from BKI treated piglets (5 pig-lets per group) before and at various time points after treatment to evaluate the concentrations of BKI 1369.7. If applicable, tissue samples (gut, liver, kidney, muscle) will be collected from BKI treated groups (3 piglets per group) at the end of the study (SD 29) to determine the risk associated with BKI 1369 residue.Analysis of samples mentioned in points 6 & 7 will be done in USA (Wesley van Voorhis’s lab).
Kurzbezeichnung
BKI-1369 C. suis dose determination
Projektleitung
Joachim Anja
Laufzeit
01.07.19-30.09.19
Art der Forschung
Experimentelle Entwicklung
Beteiligte Vetmed-Organisationseinheiten
Institut für Parasitologie
Gefördert durch
Bayer Anmial Health GmbH, Kaiser-Wilhelm-Allee 10, 51373 Leverkusen, Deutschland
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