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Monoclonal Antibodies
Syphilis Rapid Test for Syphilis
N/A
Recruiting
Led By Troy Grennan, Dr
Research Sponsored by MedMira Laboratories Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 patient visit of approximately 30 minutes
Awards & highlights
Study Summary
This trial tests a new rapid syphilis test for accuracy in STI clinics in Vancouver, compared to the standard test.
Who is the study for?
Adults over 19 attending the BCCDC STI Clinic in Vancouver for sexual health care and syphilis testing can join. It's open to those without a history of syphilis, named contacts of confirmed cases, or with other STIs. Excluded are minors, anyone unable to consent due to intoxication/distress/confusion, and individuals showing early syphilis symptoms.Check my eligibility
What is being tested?
The trial is evaluating the Reveal® TP (Syphilis) antibody POCT against standard testing methods for detecting syphilis at an urban STI clinic. The goal is to assess how well this rapid test identifies the presence of syphilis antibodies compared to conventional tests.See study design
What are the potential side effects?
Since this trial involves diagnostic testing rather than medication or treatment intervention, there are no direct side effects from the test itself. However, typical discomforts associated with blood draws may occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 patient visit of approximately 30 minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 patient visit of approximately 30 minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To determine the accuracy of Reveal TP (Syphilis) Antibody Test
Side effects data
From 2021 Phase 2 trial • 22 Patients • NCT03019640100%
Lymphocyte count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Platelet count decreased
100%
Anemia
100%
Neutrophil count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Hypotension
59%
Anorexia
55%
Hypophosphatemia
55%
Constipation
55%
Edema limbs
55%
Rash maculo-papular
50%
Headache
45%
Hypoalbuminemia
45%
Hypocalcemia
45%
Alanine aminotransferase increased
41%
Hypokalemia
41%
Dizziness
36%
Hyponatremia
36%
Anxiety
32%
Investigations
32%
Insomnia
32%
Vomiting
32%
Chills
32%
Cough
32%
Febrile neutropenia
32%
Hypertension
27%
Pain
27%
Alkaline phosphatase increased
27%
Aspartate aminotransferase increased
23%
Hypomagnesemia
23%
Infections and infestations
23%
Dysphagia
23%
Arthralgia
23%
Esophagitis
23%
Hiccups
18%
Dehydration
18%
Hypoxia
18%
Abdominal pain
18%
Allergic rhinitis
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hemorrhoids
14%
Infusion related reaction
14%
INR increased
14%
Immune system disorders
14%
Bloating
14%
Paresthesia
14%
Pleural effusion
14%
Dyspepsia
14%
Hypermagnesemia
14%
Rectal pain
9%
Upper respiratory infection
9%
Sore throat
9%
Blood bilirubin increased
9%
Bone pain
9%
Cholesterol high
9%
Creatinine increased
9%
Nasal congestion
9%
Papulopustular rash
9%
Arthritis
9%
Back pain
9%
Dry skin
9%
Dysgeusia
9%
Flushing
9%
General disorders and administration site conditions
9%
Hypernatremia
9%
Hyperuricemia
9%
Non-cardiac chest pain
9%
Renal and urinary disorders
9%
Skin ulceration
5%
Hypoglycemia
5%
Lymph node pain
5%
Tremor
5%
Hypothyroidism
5%
Lung infection
5%
Thromboembolic event
5%
Urinary tract pain
5%
Vascular disorders
5%
Weight gain
5%
Lymphocyte count increased
5%
Myalgia
5%
Urinary tract infection
5%
Urinary frequency
5%
Lung
5%
Eye disorders
5%
Gastroesophageal reflux disease
5%
Mucosal infection
5%
Metabolism and nutrition disorders
5%
Musculoskeletal and connective tissue disorder
5%
Peripheral motor neuropathy
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Rash acneiform
5%
Respiratory failure
5%
Acute kidney injury
5%
Ear pain
5%
Edema face
5%
Encephalopathy
5%
Endocrine disorders
5%
Atelectasis
5%
Atrial fibrillation
5%
Bladder infection
5%
Epistaxis
5%
Flatulence
5%
Gastrointestinal pain
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypercalcemia
5%
Neck pain
5%
Nervous system disorders
5%
Pain in extremity
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Skin hyperpigmentation
5%
Ileus
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental Diagnostic: Reveal TP (Syphilis) Antibody TestExperimental Treatment1 Intervention
Participants are tested with investigational devices and conventional syphilis serology tests.
Find a Location
Who is running the clinical trial?
MedMira Laboratories Inc.Lead Sponsor
2 Previous Clinical Trials
1,649 Total Patients Enrolled
Public Health Agency of Canada (PHAC)OTHER_GOV
45 Previous Clinical Trials
96,133 Total Patients Enrolled
Troy Grennan, DrPrincipal InvestigatorBritish Columbia Center for Disease Control (BCCDC)
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment still open for this research endeavor?
"The trial is currently enrolling, as indicated by the clinicaltrials.gov platform which shows that this study was initially posted on May 12th 2023 and updated lastly on October 3rd of the same year."
Answered by AI
What is the cap on participants for this experiment?
"Affirmative. According to clinicaltrials.gov, the medical trial is actively recruiting participants - with its launch taking place on May 12th 2023 and its last update happening on October 3rd 2023. The project requires 1000 people across 1 centre in order to be completed."
Answered by AI
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