Good Clinical Practices (GCP) Intrauterine Streptococcus zooepidemicus
SETTLE demonstrates intravenous and
intrauterine efficacy against a challenge with a
recognized pathogen in a double blinded, fully
monitored and certified, GCP regulatory study.
Although not necessary for US and
Canadian registration purposes, full GCP studies
are the standard for human and veterinary
registrations in most of the world.
Generally, endometritis is treated with hormones and
intrauterine or systemic antibiotics over a number of days. It has
been demonstrated that a single dose of SETTLE normalizes the
uterine inflammatory response and enhances the resolution of
infectious endometritis and endometriosis.2-4,6,7
In this study, SETTLE was evaluated for its ability to treat an
experimentally induced bacterial infection in endometritis-susceptible
Thirty endometritis susceptible mares were experimentally infected
with 1x109 cfu Streptococcus zooepidemicus, a recognized
intrauterine pathogen. Once the infection was confirmed, the mares
were randomly assigned to one of three treatment groups; SETTLE
intravenously (n=10), SETTLE by intrauterine instillation (n=10)
or placebo (n=5+5).
Twenty four hours later, SETTLE had cleared the infection from
5/10 mares following intravenous administration and from 6/10 mares
following intrauterine administration.
At seven days post-treatment, 7/10 mares and 8/10 mares
respectively, demonstrated negative bacterial cultures. All
placebo-treated mares remained infected during the same periods.
The results were statistically significant for both the
intravenous and intrauterine routes of administration
Additionally, mares treated with SETTLE demonstrated a
statistically significant decrease (p<0.001) in the number of PMN
in biopsy samples at 24 hours and 7 days post-treatment when
compared to the samples at pre-treatment.
Furthermore, a statistically significant reduction
(p<0.001) was observed in the volume of uterine fluids when
comparing the mares at pre-treatment
to the mares at 7 days