SyphilisNCT01540227
Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis.
An observational study of Syphilis and Primary Syphilis, run by Ottawa Hospital Research Institute at 3 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syphilis, Primary Syphilis, Secondary Syphilis
- What is being tested?
- Regular Treatment for Syphilis
- Type of treatment
- Injection or infusion
- How many people
- 25 participants
- Where
- 3 sitesCanada
- Study dates
- Sep 2011to 10 Nov 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participants must meet all of the following criteria to be considered eligible for entry into the study:
- At least 18 years of age
- Presenting with clinical signs of either primary or secondary syphilis; or with early latent syphilis and documented negative serology within the past 12 months.
- Positive syphilis serology (reactive CMIA and TP-PA) with a defined RPR titer at the time of diagnosis and enrolment
- Able to provide informed consent
- Able to communicate in either English of French
- Able to return for follow-up
Who cannot join
- Participants are not eligible to participate in the study if any of the following conditions are met:
- Diagnosis of late latent syphilis, tertiary syphilis, or syphilis of unknown duration
- Allergy to penicillin
- Diagnosis of neurosyphilis requiring treatment with intravenous penicillin
- Treatment with doxycycline or ceftriaxone
- Treatment with more than one intramuscular dose of benzathine penicillin G
Show all 10Show fewer
- Treatment with any antibiotics within the 6 weeks prior to enrolment
- Pregnant or breastfeeding
- Any immune modulating therapy
- Patient is unable or unwilling to return for blood sampling at 3 and 7 days post treatment
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Ottawa Sexual Health Clinic/GayZone
Ottawa, Ontario, K1N 5P7
Toronto General Hospital
Toronto, Ontario, M5G 2C4
About this study
Official title: Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis. Do Low Serum Penicillin Levels Correlate With Treatment Failure?
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
- Being tested
- Regular Treatment for Syphilis
- Keywords
- Syphilis, Penicillin
- Medical subject headings
- Syphilis, Syphilis, primary, Syphilis, secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular Treatment for SyphilisDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Regular Treatment for Syphilis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Penicillin and Treatment Failure
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.
Measured: 6 months post-treatment
Secondary outcomes (1)
HIV and Treatment Failure
To determine if serum penicillin levels and treatment failures differ between HIV-positive and HIV-negative individuals.
Measured: 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startSep 2011
- Primary completion10 Nov 2016
- Study completion10 Nov 2016
Why it stopped: Low enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network
- Responsible party
- Principal investigator, Paul MacPherson, Ottawa Hospital Research Institute
- Investigators
- Paul A MacPherson, MD/PhD, Principal investigator, The Ottawa Hospital/The University of Ottawa/OHRI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540227
- Sponsor's protocol ID
- CTN PT-011
- Status last verified
- Apr 2018
- First submitted
- 16 Feb 2012
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penicillin Therapeutic Drug Monitoring in the Treatment of Infectious Syphilis. Do Low Serum Penicillin Levels Correlate With Treatment Failure?
- ClinicalTrials.gov ID
- NCT01540227
- Acronym / sponsor ID
- CTN PT-011
- Conditions
- Syphilis, Primary Syphilis, Secondary Syphilis, Early-Latent Syphilis
- Keywords
- Syphilis, Penicillin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- CIHR Canadian HIV Trials Network
- Study start
- Sep 2011 (actual)
- Primary completion
- 10 Nov 2016 (actual)
- Study completion
- 10 Nov 2016 (actual)
- First posted
- 28 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Syphilis Patients | – | Drug: Regular Treatment for SyphilisIndividuals 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- Participants must meet all of the following criteria to be considered eligible for entry into the study:
- At least 18 years of age
- Presenting with clinical signs of either primary or secondary syphilis; or with early latent syphilis and documented negative serology within the past 12 months.
- Positive syphilis serology (reactive CMIA and TP-PA) with a defined RPR titer at the time of diagnosis and enrolment
- Able to provide informed consent
Key exclusion criteria (10 listed)
- Participants are not eligible to participate in the study if any of the following conditions are met:
- Diagnosis of late latent syphilis, tertiary syphilis, or syphilis of unknown duration
- Allergy to penicillin
- Diagnosis of neurosyphilis requiring treatment with intravenous penicillin
- Treatment with doxycycline or ceftriaxone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regular Treatment for SyphilisDrug: Benzathine Penicillin G (Bicillin) Dose: 2.4 million units Mode of Administration: intramuscular injection Duration of Treatment: one dose Health Canada approved indication: Yes | Drug | Syphilis Patients |
Primary outcome
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.
1 secondary outcome
HIV and Treatment Failure
Time frame: 6 months post-treatment
Results and safety
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul A MacPherson, MD/PhD principal investigator
The Ottawa Hospital/The University of Ottawa/OHRI
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Syphilis and Primary Syphilis, run by Ottawa Hospital Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Penicillin and Treatment Failure (time frame: 6 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.