Subcutaneous Daptomycin in Healthy Volunteers (DAPTOSC)
Status:
Recruiting
Trial end date:
2022-06-01
Target enrollment:
Participant gender:
Summary
Background:
Multidrug-resistant bacteria are a major public health problem worldwide, notably due to
excess mortality and an increase in the length of hospital stay. Antibiotics that can be used
to treat these infections are limited. Daptomycin is one of the most widely used antibiotics
for the treatment of infections with gram-positive bacteria, such as methicillin-resistant
Staphylococcus aureus (MRSA). However, it is only administered intravenously (IV). It is
therefore interesting to find new routes of administration in order to widen the
possibilities of using daptomycin, especially in people who have difficulties with the venous
approach.
Methods/design:
In a randomized, single blinded, crossover, noninferiority study in the CHU of Caen, the
investigators aim to demonstrate the pharmacokinetic bioequivalence between the subcutaneous
and the intravenous route of daptomycin in healthy volunteers. They will conclude the
bioequivalence if the confidence interval of the area under the curve obtained is entirely
within the interval [80% - 125%].
Discussion:
This clinical trial could, if bioequivalence is demonstrated, lead to the completion of a
clinical trial in infected patients in order to assess the efficacy and safety of daptomycin
by the subcutaneous route.