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Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.

NCT01540227 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2018-04-06

No results posted yet for this study

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.

Conditions

  • Syphilis
  • Primary Syphilis
  • Secondary Syphilis
  • Early-Latent Syphilis

Interventions

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

Sponsors & Collaborators

  • CIHR Canadian HIV Trials Network

    collaborator NETWORK

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Paul A MacPherson, MD/PhD · The Ottawa Hospital/The University of Ottawa/OHRI

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-11-10
Completion
2016-11-10

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01540227 on ClinicalTrials.gov