Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.
Status:
Terminated
Trial end date:
2016-11-10
Target enrollment:
Participant gender:
Summary
Syphilis is a sexually transmitted infection that causes genital sores and rash, but in some
circumstances may result in more severe and unexpected symptoms. These severe symptoms could
include eye infections, meningitis (infection of the membranes covering the brain and spinal
cord), and liver infection. If not properly treated, syphilis can also lead to heart problems
and dementia (a decline in reasoning, memory and other mental abilities) years down the road.
There has been an increase in the number of reported cases of syphilis in North America,
Europe, and Australia over the past decade. The number of new syphilis infections in Canada
has increased roughly 10-fold over the past 10 years.
Since 1943, the antibiotic penicillin has been used to treat syphilis; however, very little
information has been gathered to determine the proper dose of penicillin or appropriate
duration of treatment. Added to this, several studies have shown that the recommended dose of
penicillin fails to cure syphilis in 20-30% of patients. Since the number of people infected
with syphilis is increasing, and since syphilis has the potential to cause serious disease,
the investigators need better information on how to treat syphilis effectively.
This study aims to determine whether the current dose of penicillin recommended to treat
syphilis is sufficient to cure the infection. Specifically the investigators will try to
determine whether the amount of penicillin in your blood 3 and 7 days after receiving
treatment for syphilis is sufficient to cure the infection as demonstrated by a blood test 6
or 12 months from now. This study is a multi-centered trial based in Ottawa but with centers
recruiting both in Montreal and Toronto. A total of 120 participants with syphilis will be
recruited into this study. The treatment you will receive for syphilis in this study does not
differ from that you would receive normally; the investigators are only observing the levels
of penicillin in your blood and relating them with the outcome of treatment.