Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01540227
Study type	Observational
Source	Ottawa Hospital Research Institute
Contact
Status	Terminated
Phase
Start date	September 2011
Completion date	November 10, 2016

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See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms