ClinVet International Pty Ltd.

Bloemfontein, South Africa

ClinVet International Pty Ltd.

Bloemfontein, South Africa
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Schall R.,University of the Free State | Burger D.A.,University of the Free State | Erasmus T.P.,ClinVet International Pty Ltd
Veterinary Parasitology | Year: 2016

In animal studies of ectoparasiticide efficacy the total number of parasites with which experimental animals are infested is not always equal to the intended number of parasites (usually n = 50 per experimental animal in the case of ticks, and n = 50 or n = 100 in the case of fleas). That is, in the practical implementation of a study protocol, the infestation of experimental animals may be subject to variability so that total infestation is not known precisely. The purpose of the present study is to assess the impact of this variability on the accuracy and precision of efficacy estimates. The results of a thorough simulation study show clearly that uncertainty in total parasite infestation – of the magnitude encountered in well-controlled animal studies – has virtually no effect on the accuracy and precision of estimators of ectoparasiticide efficacy. © 2016 Elsevier B.V.


Schall R.,University of the Free State | Burger D.A.,University of the Free State | Luus H.G.,ClinVet International Pty Ltd
Veterinary Parasitology | Year: 2016

While there is consensus that the efficacy of parasiticides is properly assessed using the Abbott formula, there is as yet no general consensus on the use of arithmetic versus geometric mean numbers of surviving parasites in the formula. The purpose of this paper is to investigate the accuracy and precision of various efficacy estimators based on the Abbott formula which alternatively use arithmetic mean, geometric mean and median numbers of surviving parasites; we also consider a maximum likelihood estimator. Our study shows that the best estimators using geometric means are competitive, with respect to root mean squared error, with the conventional Abbott estimator using arithmetic means, as they have lower average and lower median root mean square error over the parameter scenarios which we investigated. However, our study confirms that Abbott estimators using geometric means are potentially biased upwards, and this upward bias is substantial in particular when the test product has substandard efficacy (90% and below). For this reason, we recommend that the Abbott estimator be calculated using arithmetic means. © 2016 Elsevier B.V.


Beugnet F.,Merial | Fourie J.,ClinVet International Pty Ltd. | Chalvet-Monfray K.,Applied Biomathematics, Inc.
Parasite | Year: 2012

Flea infestations of pets continue to persist due to the lack of knowledge of flea biology and ecology. It is not unusual that pet owners believe regular hygiene, such as shampooing their dogs can replace regular insecticidal treatment. The objective of this study was to compare in a flea simulated environment, modelling exposure similar to that found in a home, that the use of regular physiological shampoo does not control fleas adequately when compared to a long acting topical formulation. Three groups of six dogs were formed: one untreated control group, one group treated monthly with the topical formulation of fipronil/(S)-methoprene, and a third group treated weekly with a hygiene shampoo. All dogs were infested with adult unfed Ctenocephalides felis fleas (200 ± 5) on Days-28 and -21. Each animal's sleeping box was fitted with a plastic cup mounted to the inside roof of the box. The sleeping bench of each animal was covered with a carpet to accommodate flea development. The dogs were maintained in their kennels throughout the study. In order to maintain the environmental flea challenge, C. felis pupae (100 ± 5) were placed in the plastic cup in each animal's sleeping box on Days-14, - 7, 0, 7, 14, 21, 28, 35 and 42. The dogs were combed and fleas counted weekly on Days - 1, 3, 1 0, 17, 2 4, 31, 3 8, 45, and 51. The fleas were placed immediately back on the dogs. On Day 60, fleas were counted and removed. Flea infestations in the untreated control group at each count averaged between 46.2 and 74.2 fleas throughout the study. The average number of fleas infesting dogs was significantly different (p< 0.05) between the untreated and the two treatment groups and between the two treatment groups at all counts throughout the two months study (Days 3, 10, 1 7, 24, 3 1, 38, 45, 51 and 60). The efficacy was never below 99.1 % in the fipronil/(S)-methoprene group, and efficacy in the shampoo group was never above 79.2 %. Weekly shampooing in treatment group 3 was intentionally delayed after Day 42, to evaluate wether missing a weekly bath would affect the flea population. The Day 48 data indicate that forgetting or delaying a single weekly shampooing resulted in a clear increase in flea numbers and a significant decrease in efficacy from 68.2 % to 34.8 %. The fipronil(S)/methoprene treatment allowed a continuous control as demonstrated by the high efficacy against fleas, and also the number of flea-free dogs on seven of the nine weekly assessments, in spite of what was essentially a continuous flea challenge model.


PubMed | MSD Animal Health Innovation SAS, MSD Animal Health Innovation GmbH and Clinvet International Pty Ltd
Type: Journal Article | Journal: Parasites & vectors | Year: 2017

The efficacy of fluralaner for the treatment of Otodectes cynotis infestations in dogs and cats was evaluated after oral (dogs) or topical administration (dogs and cats). Twenty-four dogs and sixteen cats were experimentally infested with O. cynotis and randomly allocated to equal sized groups (n=8/group). Dog groups were treated once, either orally with fluralaner at a minimum dose of 25mg/kg body weight, topically with fluralaner at a dose of 25mg/kg body weight or topically with saline solution (control). Cat groups were treated once, either topically with fluralaner at a dose of 40mg/kg body weight or topically with saline solution. Ears of all animals were examined otoscopically for live visible mites and the amount of debris and cerumen before, and 14 and 28days after treatment. Twenty-eight days after treatment, animals were sedated and both ears were flushed to obtain the total number of live mites per animal. The efficacy was calculated, based on the results of the ear flushing, by comparing mean live mite counts in the fluralaner treated groups versus the saline solution treated group.A single topical treatment of cats with fluralaner reduced the mean mite counts by 100% (P<0.001) at 28days after treatment. Similarly, a single oral or topical treatment of dogs with fluralaner reduced the mean mite counts by 99.8% (P<0.001) at 28days after treatment. Cats treated topically with fluralaner had no mites visible during otoscopic examination at either 14 or 28days after treatment. All dogs treated orally or topically with fluralaner had no mites visible during otoscopic examination at 28days after treatment. At 14days after treatment, only 1-2 mites were visible in three dogs (oral treatment: 2 dogs, topical treatment: 1 dog). All fluralaner-treated animals showed improvement in the amount of cerumen exudation compared with observations performed before treatment. No treatment related adverse events were observed in any dogs or cats enrolled in these studies.In this study, fluralaner administered topically to cats and orally or topically to dogs was highly effective against Otodectes cynotis mite infestations.


PubMed | University of the Free State and ClinVet International Pty Ltd
Type: | Journal: Veterinary parasitology | Year: 2016

While there is consensus that the efficacy of parasiticides is properly assessed using the Abbott formula, there is as yet no general consensus on the use of arithmetic versus geometric mean numbers of surviving parasites in the formula. The purpose of this paper is to investigate the accuracy and precision of various efficacy estimators based on the Abbott formula which alternatively use arithmetic mean, geometric mean and median numbers of surviving parasites; we also consider a maximum likelihood estimator. Our study shows that the best estimators using geometric means are competitive, with respect to root mean squared error, with the conventional Abbott estimator using arithmetic means, as they have lower average and lower median root mean square error over the parameter scenarios which we investigated. However, our study confirms that Abbott estimators using geometric means are potentially biased upwards, and this upward bias is substantial in particular when the test product has substandard efficacy (90% and below). For this reason, we recommend that the Abbott estimator be calculated using arithmetic means.


Becskei C.,Zoetis Inc. | Geurden T.,Zoetis Inc. | Erasmus H.,ClinVet International Pty Ltd | Cuppens O.,Zoetis Inc. | And 2 more authors.
Parasites and Vectors | Year: 2016

Background: Ticks are common ectoparasites that infest dogs globally. Acaricides with rapid and sustained speed of kill are critical to control infestations and to reduce the risk of disease transmission. This study evaluated the speed of kill for 5 weeks after a single dose of orally administered Simparica™(sarolaner) against induced infestations with Dermacentor reticulatus on dogs, compared to Advantix®Spot-on solution for dogs (imidacloprid + permethrin). Methods: Twenty four dogs were randomly allocated to treatment with either a placebo tablet, a sarolaner tablet (at 2 to 4 mg/kg) or with Advantix® as per label instructions. Dogs were treated on Day 0 and tick counts were performed in situ at 8 and 12 hours and with removal of the ticks at 24 hours after treatment and subsequent re-infestations on Days 7, 14, 21, 28 and 35. Acaricidal efficacy was determined at each time point relative to live tick counts from the placebo-treated dogs. Results: Based on arithmetic (geometric) mean tick counts, the efficacy of sarolaner was ≥75.6 % (89.6 %) within 8 hours of treatment and tick counts were significantly lower than placebo and imidacloprid + permethrin-treated dogs (P < 0.0001), while imidacloprid + permethrin had no significant reduction (P ≥ 0.3990) at 8 or 12 hours after treatment. Sarolaner killed all ticks on the dogs within 24 hours after treatment, while imidacloprid + permethrin efficacy was only 48.1 %. After weekly re-infestations sarolaner significantly reduced the tick counts versus placebo within 8 hours on Days 7, 14 and 35 (P ≤ 0.0239), and at 12 hours and 24 hours (P ≤ 0.0079) until Day 35.Sarolaner efficacy was ≥95.8 % within 24 hours for 35 days. Significantly more live ticks (P ≤ 0.0451) were recovered from imidacloprid + permethrin-treated dogs than from sarolaner-treated dogs at 24 hours after infestation on all days. There were no sarolaner-related adverse reactions during the study. Conclusions: This study demonstrated that Simparica™ had a faster and more consistent speed of kill against D. reticulatus compared to Advantix®. The rapid and consistent efficacy within 24 hours for 5 weeks after a single oral dose of Simparica™ provides effective and reliable control of D. reticulatus and reduces the risk of transmission of tick-borne diseases. © 2016 Becskei et al.


Six R.H.,Zoetis Inc. | Liebenberg J.,ClinVet International Pty Ltd | Honsberger N.A.,Zoetis Inc. | Mahabir S.P.,Zoetis Inc.
Parasites and Vectors | Year: 2016

Background: Fleas are the most common ectoparasite infesting dogs globally. The many possible sequellae of infestation include: direct discomfort; allergic reactions; and the transmission of pathogens. Rapid speed of kill is an important characteristic for a parasiticide in order to alleviate the direct deleterious effects of fleas, reduce the impact of allergic responses, and break the flea infestation cycle. In this study, the speed of kill of a novel orally administered isoxazoline parasiticide, sarolaner (Simparica™) against fleas on dogs was evaluated and compared with afoxolaner (NexGard®) for 5 weeks after a single oral dose. Methods: Twenty-four dogs were randomly allocated to treatment with a single oral dose at label rate of either sarolaner (2 to 4 mg/kg) or afoxolaner (2.5 to 6.8 mg/kg) or placebo, based on pretreatment flea counts. Dogs were combed and live fleas counted at 8, 12 and 24 h after treatment and subsequent re-infestations on Days 7, 14, 21, 28 and 35. Efficacy was determined at each time point relative to counts for placebo dogs. Results: There were no adverse reactions to treatment. A single oral dose of sarolaner provided ≥98.8 % efficacy (based on geometric means) within 8 h of treatment or subsequent weekly re-infestations of fleas to Day 35. By 12 h, fleas were virtually eradicated from all dogs, with only two fleas recovered from a single sarolaner-treated dog on Day 7; efficacy was 100 % at all other time points. Significantly greater numbers of live fleas were recovered from afoxolaner-treated dogs at 8 h on all days and at 12 h on Days 28 and 35 (P < 0.05). Conclusions: In this controlled laboratory evaluation, sarolaner had a significantly faster speed of kill against fleas than afoxolaner. This was noticeably more evident towards the end of the treatment period. The rapid and consistent kill of fleas within 8 to 12 h after a single oral dose of sarolaner over 35 days indicates that this treatment will provide highly effective control of flea infestations, relief for dogs afflicted with flea allergy dermatitis, and should reduce the risk of flea-borne pathogen transmission. © 2016 Six et al.


Six R.H.,Zoetis Inc. | Liebenberg J.,ClinVet International Pty Ltd | Honsberger N.A.,Zoetis Inc. | Mahabir S.P.,Zoetis Inc.
Parasites and Vectors | Year: 2016

Background: Fleas are the most common ectoparasite infesting dogs globally and cause direct discomfort, induce allergic reactions, and transmit pathogenic agents. Rapid speed of kill is an important characteristic for a parasiticide in order to alleviate the direct deleterious effects of fleas, reduce the impact of allergic responses, and break the flea life cycle. In this study, the speed of kill of a novel, orally administered isoxazoline parasiticide, sarolaner (Simparica™), against fleas on dogs was evaluated and compared with fluralaner (Bravecto®) over a 3-month period. Methods: Based on pretreatment flea counts, 24 dogs were randomly allocated to treatment with oral sarolaner at the label rate (2 to 4 mg/kg), once a month for 3 months, or oral fluralaner (25 to 50 mg/kg), once per label directions, or placebo. Dogs were combed and live fleas counted at 8, 12, and 24 h after treatment and subsequent re-infestations on Days 14, 29, 44, 59, 74 and 90. Efficacy was determined at each time point relative to counts for placebo dogs. Results: There were no adverse reactions to treatment. Three monthly doses of sarolaner provided ≥97.6 % efficacy (based on arithmetic means) within 8 h of treatment or subsequent weekly re-infestations of fleas for 3 months. By 12 h, fleas were eradicated from all dogs (100 % efficacy). Significantly greater numbers of live fleas were recovered from fluralaner-treated dogs at 8 h on Days 74 and 90 (P ≤ 0.0043) when efficacy (based on arithmetic means) was only 80.7 and 72.6 %, respectively. Conclusions: In this controlled laboratory evaluation, sarolaner had a significantly faster speed of kill against fleas than fluralaner at the end of its claimed treatment period. The rapid and consistent kill of fleas within 8 to 12 h after monthly oral doses of sarolaner indicates that this treatment will provide rapid and highly effective control of flea infestations, and suggests that it will provide relief for dogs suffering from flea allergy dermatitis, and should reduce the risk of flea-borne pathogen transmission. © 2016 Six et al.


PubMed | ClinVet International pty Ltd. and Zoetis Inc.
Type: | Journal: Veterinary parasitology | Year: 2016

Three laboratory studies were conducted to determine the appropriate dose of sarolaner, a novel isoxazoline, for the treatment and month-long control of infestations of fleas and ticks on dogs. In the first study, dogs were treated orally with sarolaner suspension formulations at 1.25, 2.5 or 5.0mg/kg, and infested with Dermacentor reticulatus, Rhipicephalus sanguineus ticks and with Ctenocephalides felis felis (cat flea) prior to treatment and then weekly for up to 8 weeks. Fleas and ticks were counted 48h after treatment and after each subsequent infestation at 24h for fleas and 48h for ticks. The lowest dose of sarolaner (1.25mg/kg) provided 100% efficacy against fleas from treatment through Day 35 and 98.4% at Day 56. This dose of sarolaner resulted in 99.7-100% control of both species of ticks through Day 28. In Study 2, dogs were dosed orally with placebo or sarolaner suspension formulations at 0.625, 1.25 or 2.5mg/kg and infested with Ixodes scapularis prior to treatment and weekly for 6 weeks, Amblyomma americanum (pretreatment and Day 26), Dermacentor variabilis (Day 33) and A. maculatum (Day 41). Ixodes scapularis was the most susceptible; the lowest dose (0.625mg/kg) providing>95% efficacy through Day 43. Efficacy against D. variabilis on Day 35 was>95% at 1.25 and 2.5mg/kg, whereas the 0.625mg/kg dose gave only 61.4% efficacy. Amblyomma spp. were the least susceptible ticks; efficacy of the 1.25mg/kg dose at Day 28 for A. americanum was markedly lower (88.5%) than achieved for D. reticulatus (100%) at Day 28 and also lower than for D. variabilis at Day 35 (96.2%). In Study 3, dogs were dosed orally with placebo or sarolaner in the proposed commercial tablet (Simparica) at 1.0, 2.0 or 4.0mg/kg, and infested with A. maculatum, one of the ticks determined to be dose limiting, prior to treatment and then weekly for 5 weeks. All doses gave 100% control of the existing infestation. The two highest dosages resulted in >93% control of subsequent challenges for 5 weeks. There was no significant improvement in efficacy provided by the 4.0 mg/kg dose over the 2.0mg/kg dose (P>0.05) at any time point. The 2.0mg/kg dose was superior to the 1.0mg/kg on Day 14 (P=0.0086) and as efficacy for 1.0mg/kg declined below 90% at Day 28, a single 1mg/kg dose would not provide a full month of tick control. Thus, 2.0mg/kg was selected as the sarolaner dose rate to provide flea and tick control for at least one month following a single oral treatment.


PubMed | ClinVet International Pty Ltd. and Zoetis Inc.
Type: | Journal: Veterinary parasitology | Year: 2016

The efficacy of the novel isoxazoline, sarolaner (Simparica) was investigated in dogs with clinical signs consistent with sarcoptic mange and harbouring natural infestations of Sarcoptes scabiei. One placebo-controlled laboratory study and one multi-centred field study with a commercial comparator containing imidacloprid/moxidectin (Advocate() spot-on) were conducted. Oral or topical treatments were administered on Days 0 and 30. Up to 10 skin scrapings were taken for the assessment of S. scabiei infestations from each dog before treatment and on Days 14, 30, 44 and 60 in the laboratory study, and on Days 30 and 60 in the field study. In the laboratory study, efficacy was calculated based on the percent reduction of mean live mite counts compared to the placebo group. In the field study parasitological cure rate (% dogs free of mites) was determined and non-inferiority of sarolaner to the control product was assessed. In the laboratory study 44 mixed breed dogs were enrolled in four batches. Due to decreasing mite counts in the placebo treated dogs, immunosuppression with dexamethasone (0.4mg/kg three times per week for two weeks) was initiated in all dogs on study at that time (n=6) and those subsequently enrolled (n=14). In the field study, dogs were enrolled in a 2:1 ratio (sarolaner:comparator); 79 dogs were assessed for efficacy and safety, and an additional 45 dogs were assessed for safety only. There were no treatment related adverse events in either study. In the laboratory study, no mites were found on any sarolaner-treated dogs 14 days after the first treatment except for one dog that had a single mite on Day 44. In the field study, the parasitological cure rate was 88.7% and 100% in the sarolaner group and 84.6% and 96.0% in the imidacloprid/moxidectin group, on Days 30 and 60, respectively. Statistical analysis showed that sarolaner was non-inferior to imidacloprid/moxidectin at both time points. The clinical signs of sarcoptic mange, including hair loss, papules, pruritus, erythema, and scaling/crusting improved throughout the study. Sarolaner was safe, achieved 100% reduction in the numbers of S. scabiei detected and resulted in marked improvement of the clinical signs of sarcoptic mange in dogs following two monthly oral administrations.

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