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Monoclonal Antibodies

Antibody Test for Syphilis

N/A
Waitlist Available
Led By Patrick O'Byrne, PhD
Research Sponsored by MedMira Laboratories Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients attending Clinic for follow up appointments following diagnosis with syphilis infection
Minimum 16 years of age
Must not have
Unable to provide informed consent due to possible intoxication and/or with extreme distress or confused
Patients below the age of 16 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Summary

"This trial is testing a new syphilis antibody test called the Multiplo Complete Syphilis Antibody Test in an urban STI clinic. They will be using a finger-prick blood sample to

Who is the study for?
This clinical trial is for individuals visiting a sexual health clinic in Ottawa who may have syphilis. The study aims to include participants from this specific urban population without any further specified inclusion or exclusion criteria provided.
What is being tested?
The trial is evaluating the Multiplo Complete Syphilis (TP/nTP) Antibody Test, which uses a finger-prick blood sample to quickly diagnose syphilis at the point of care within the clinic setting.
What are the potential side effects?
Since this trial involves diagnostic testing rather than medication or intervention, side effects are minimal and may include temporary discomfort or bruising at the site of the finger prick.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am following up at the clinic after being diagnosed with syphilis.
Select...
I am at least 16 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am able to understand and consent to my treatment.
Select...
I am under 16 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine if a POCT for syphilis administered at a clinic, can provide comparable results to those obtained by conventional laboratory testing.
Secondary outcome measures
To evaluate the feasibility and utility (acceptability by patients) of this POCT in the patient population under study.

Side effects data

From 2021 Phase 2 trial • 22 Patients • NCT03019640
100%
Anemia
100%
Neutrophil count decreased
100%
White blood cell decreased
100%
Nausea
100%
Fever
100%
Lymphocyte count decreased
100%
Platelet count decreased
95%
Diarrhea
82%
Hyperglycemia
77%
Mucositis oral
77%
Fatigue
64%
Sinus tachycardia
59%
Anorexia
59%
Hypotension
55%
Constipation
55%
Rash maculo-papular
55%
Edema limbs
55%
Hypophosphatemia
50%
Headache
45%
Alanine aminotransferase increased
45%
Hypoalbuminemia
45%
Hypocalcemia
41%
Dizziness
41%
Hypokalemia
36%
Anxiety
36%
Hyponatremia
32%
Vomiting
32%
Cough
32%
Hypertension
32%
Chills
32%
Insomnia
32%
Investigations
32%
Febrile neutropenia
27%
Aspartate aminotransferase increased
27%
Alkaline phosphatase increased
27%
Pain
23%
Arthralgia
23%
Hiccups
23%
Dysphagia
23%
Esophagitis
23%
Hypomagnesemia
23%
Infections and infestations
18%
Abdominal pain
18%
Allergic rhinitis
18%
Hemorrhoids
18%
Dehydration
18%
Dyspnea
18%
Generalized muscle weakness
18%
Hypoxia
14%
Bloating
14%
Hypermagnesemia
14%
Dyspepsia
14%
Paresthesia
14%
Rectal pain
14%
Infusion related reaction
14%
Immune system disorders
14%
INR increased
14%
Pleural effusion
9%
Arthritis
9%
Back pain
9%
Blood bilirubin increased
9%
Renal and urinary disorders
9%
Skin ulceration
9%
Sore throat
9%
Creatinine increased
9%
Cholesterol high
9%
Dysgeusia
9%
Hypernatremia
9%
Upper respiratory infection
9%
Bone pain
9%
Dry skin
9%
Flushing
9%
Non-cardiac chest pain
9%
General disorders and administration site conditions
9%
Hyperuricemia
9%
Nasal congestion
9%
Papulopustular rash
5%
Urinary tract infection
5%
Weight gain
5%
Encephalopathy
5%
Acute kidney injury
5%
Respiratory failure
5%
Lung
5%
Atrial fibrillation
5%
Bladder infection
5%
Ear pain
5%
Epistaxis
5%
Eye disorders
5%
Flatulence
5%
Gastroesophageal reflux disease
5%
Gastrointestinal pain
5%
Hypercalcemia
5%
Nervous system disorders
5%
Rash acneiform
5%
Skin hyperpigmentation
5%
Thromboembolic event
5%
Tremor
5%
Urinary frequency
5%
Atelectasis
5%
Edema face
5%
Endocrine disorders
5%
Metabolism and nutrition disorders
5%
Mucosal infection
5%
Neck pain
5%
Prostatic obstruction
5%
Pulmonary edema
5%
Hematuria
5%
Hemorrhoidal hemorrhage
5%
Hypoglycemia
5%
Musculoskeletal and connective tissue disorder
5%
Myalgia
5%
Hypothyroidism
5%
Lung infection
5%
Lymph node pain
5%
Lymphocyte count increased
5%
Pain in extremity
5%
Peripheral motor neuropathy
5%
Restlessness
5%
Sinus bradycardia
5%
Sinusitis
5%
Skin and subcutaneous tissue disorder
5%
Urinary tract pain
5%
Vascular disorders
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: Multiplo Complete Syphilis (TP/nTP) Antibody TestExperimental Treatment1 Intervention
Subjects are tested with investigational devices and conventional syphilis serology tests.

Find a Location

Who is running the clinical trial?

MedMira Laboratories Inc.Lead Sponsor
3 Previous Clinical Trials
2,649 Total Patients Enrolled
1 Trials studying Syphilis
1,000 Patients Enrolled for Syphilis
Patrick O'Byrne, PhDPrincipal InvestigatorSexual Health Clinic
~400 spots leftby Jun 2025
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