Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01540227|
Recruitment Status : Enrolling by invitation
First Posted : February 28, 2012
Last Update Posted : October 5, 2016
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.
|Condition or disease||Intervention/treatment|
|Syphilis Primary Syphilis Secondary Syphilis Early-Latent Syphilis||Drug: Regular Treatment for Syphilis|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|Official Title:||Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis. Do Low Serum Penicillin Levels Correlate With Treatment Failure?|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||September 2018|
Individuals presenting for treatment of primary, secondary or early latent syphilis at the Ottawa Hospital Immunodeficiency Clinic, the Ottawa Sexual Health Clinic or its satellite GayZone, the Montreal Chest Institute Immunodeficiency Clinic, or the Toronto General Immunodeficiency Clinic will be invited by their attending health care worker to participate in this study. Only patients presenting for and requiring treatment of infectious syphilis will be asked to participate.
Drug: Regular Treatment for Syphilis
Drug: Benzathine Penicillin G (Bicillin)
Dose: 2.4 million units
Mode of Administration: intramuscular injection
Duration of Treatment: one dose
Health Canada approved indication: Yes
- Penicillin and Treatment Failure [ Time Frame: 6 months post-treatment ]To determine if serum penicillin concentrations measured at days 3 and 7 post-treatment differ between those who achieve successful treatment of infectious syphilis versus those who experience treatment failure.
- HIV and Treatment Failure [ Time Frame: 6 months post-treatment ]To determine if serum penicillin levels and treatment failures differ between HIV-positive and HIV-negative individuals.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01540227
|The Ottawa Hospital|
|Ottawa, Ontario, Canada, K1H 8L6|
|Ottawa Sexual Health Clinic/GayZone|
|Ottawa, Ontario, Canada, K1N 5P7|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Paul A MacPherson, MD/PhD||The Ottawa Hospital/The University of Ottawa/OHRI|