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Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
CIHR Canadian HIV Trials Network
Information provided by (Responsible Party):
Paul MacPherson, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01540227
First received: February 16, 2012
Last updated: October 14, 2014
Last verified: October 2014
  Purpose

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 Intervention
Syphilis
Primary Syphilis
Secondary Syphilis
Early-Latent Syphilis
Drug: Regular Treatment for Syphilis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis. Do Low Serum Penicillin Levels Correlate With Treatment Failure?

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Penicillin and Treatment Failure [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • HIV and Treatment Failure [ Time Frame: 6 months post-treatment ] [ Designated as safety issue: No ]
    To determine if serum penicillin levels and treatment failures differ between HIV-positive and HIV-negative individuals.


Estimated Enrollment: 120
Study Start Date: September 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Syphilis Patients
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


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals presenting for treatment of primary, secondary or early latent syphilis 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.

Criteria

Inclusion Criteria:

Participants must meet all of the following criteria to be considered eligible for entry into the study:

  1. At least 18 years of age
  2. Presenting with clinical signs of either primary or secondary syphilis; or with early latent syphilis and documented negative serology within the past 12 months.
  3. Positive syphilis serology (reactive CMIA and TP-PA) with a defined RPR titer at the time of diagnosis and enrolment
  4. Able to provide informed consent
  5. Able to communicate in either English of French
  6. Able to return for follow-up

Exclusion Criteria:

Participants are not eligible to participate in the study if any of the following conditions are met:

  1. Diagnosis of late latent syphilis, tertiary syphilis, or syphilis of unknown duration
  2. Allergy to penicillin
  3. Diagnosis of neurosyphilis requiring treatment with intravenous penicillin
  4. Treatment with doxycycline or ceftriaxone
  5. Treatment with more than one intramuscular dose of benzathine penicillin G
  6. Treatment with any antibiotics within the 6 weeks prior to enrolment
  7. Pregnant or breastfeeding
  8. Any immune modulating therapy
  9. Patient is unable or unwilling to return for blood sampling at 3 and 7 days post treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01540227

Locations
Canada, Ontario
Ottawa Sexual Health Clinic/GayZone
Ottawa, Ontario, Canada, K1N 5P7
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
Ottawa Hospital Research Institute
CIHR Canadian HIV Trials Network
Investigators
Principal Investigator: Paul A MacPherson, MD/PhD The Ottawa Hospital/The University of Ottawa/OHRI
  More Information

No publications provided

Responsible Party: Paul MacPherson, Physician/Scientist, Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01540227     History of Changes
Other Study ID Numbers: CTN PT-011
Study First Received: February 16, 2012
Last Updated: October 14, 2014
Health Authority: Canada: Health Canada

Keywords provided by Ottawa Hospital Research Institute:
Syphilis
Penicillin

Additional relevant MeSH terms:
Chancre
Syphilis
Syphilis, Latent
Bacterial Infections
Genital Diseases, Female
Genital Diseases, Male
Gram-Negative Bacterial Infections
Infection
Sexually Transmitted Diseases
Sexually Transmitted Diseases, Bacterial
Spirochaetales Infections
Treponemal Infections

ClinicalTrials.gov processed this record on November 25, 2014