Gonorrhea Clinical Trial
Official title:
Clinical Study Protocol for the Illumigene® Chlamydia and Illumigene® Gonorrhea DNA Amplification Assays
Verified date | September 2014 |
Source | Meridian Bioscience, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To evaluate the illumigene Chlamydia and illumigene Gonorrhea assays, using the illumipro-10, with male urine, female urine, physician-collected (medical professional) endocervical swabs and self-collected vaginal swabs taken from symptomatic and asymptomatic patient populations.
Status | Completed |
Enrollment | 700 |
Est. completion date | September 9, 2014 |
Est. primary completion date | September 9, 2014 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years to 89 Years |
Eligibility |
Inclusion Criteria: 1. Male or female 2. Any ethnicity or race 3. Subject >14 and <89 years of age 4. Subject who voluntarily gives written informed consent; not applicable for leftover specimens 5. Symptomatic or asymptomatic subject who is able and willing to provide the required urine and swab samples for testing for CT and NG 6. Leftover urine specimens Exclusion Criteria: 1. Subjects < 14 or >90 years of age 2. Subjects who are unwilling to sign the written informed consent; not applicable for leftover specimens 3. Subject who is unwilling or unable to provide the required urine and swab samples for testing; not applicable for leftover specimens 4. Individuals who have been on antibiotic medications within 10 days. 5. Multiple sets of specimens from the same subject at different office visits 6. Samples collected or processed in manner other than specified in the study protocol and Investigational Use Only package insert. 7. Frozen archived specimens |
Country | Name | City | State |
---|---|---|---|
United States | Planned Parenthood of the Rocky Mountains | Aurora | Colorado |
United States | New England Center for Clinical Research | Fall River | Massachusetts |
United States | Planned Parenthood Southeastern PA | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Meridian Bioscience, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhoeae (GC) to aid in the diagnosis of chlamydial and/or gonococcal urogenital disease | Testing of each set of subject samples is completed within 60 days of sample collection | Up to 60 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01439503 -
Safer Sex Program for Young African-American Men
|
Phase 2 | |
Completed |
NCT00381992 -
Risk Assessment of Long-Haul Truck Drivers
|
N/A | |
Completed |
NCT03294395 -
New AntiBiotic Treatment Options for Uncomplicated Anogenital GOnorrhoea
|
Phase 3 | |
Not yet recruiting |
NCT06428643 -
A Seek, Test, and Treat Intervention to Reduce Chlamydia Trachomatis Disparities
|
N/A | |
Completed |
NCT03896776 -
A Pragmatic Trial of Two Strategies for Implementing an Effective eHealth HIV Prevention Program (Keep It Up! 3.0)
|
N/A | |
Completed |
NCT03718806 -
Study to Investigate Effect of Food and Safety of a New Formulation of Zoliflodacin
|
Phase 1 | |
Completed |
NCT04010539 -
A Study Evaluating Efficacy and Safety of Gepotidacin Compared With Ceftriaxone Plus Azithromycin in the Treatment of Uncomplicated Urogenital Gonorrhea
|
Phase 3 | |
Completed |
NCT00187902 -
Evaluation of NAATs for Detection of C. Trachomatis and N. Gonorrhoeae From Pharynx, Rectum, Glans & Urethra of MSM
|
N/A | |
Completed |
NCT00262106 -
Trial to Evaluate PRO 2000/5 Gels for the Prevention of Vaginally Acquired HIV Infection
|
Phase 3 | |
Completed |
NCT00207506 -
Lay Health Advisors for Sexually Transmitted Disease Prevention
|
Phase 1/Phase 2 | |
Completed |
NCT04553068 -
Evaluation of EVO100 for Prevention of Urogenital Chlamydia Trachomatis and Neisseria Gonorrhoeae Infection
|
Phase 3 | |
Active, not recruiting |
NCT03959527 -
Zoliflodacin in Uncomplicated Gonorrhoea
|
Phase 3 | |
Active, not recruiting |
NCT03980223 -
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men
|
Phase 4 | |
Completed |
NCT01465607 -
Implementation of an Efficacious Intervention for High Risk Women in Mexico
|
N/A | |
Terminated |
NCT00120770 -
Cellulose Sulfate (CS) Gel and HIV in Nigeria
|
Phase 3 | |
Completed |
NCT02391233 -
Multimedia WORTH With Black Drug-Involved Women on Probation
|
N/A | |
Recruiting |
NCT05766904 -
Efficacy Trial on Meningococcal B Vaccine for Preventing Gonorrhea Infections
|
Phase 3 | |
Completed |
NCT04297436 -
Gonococcal Vaccine Study in Key Populations in Kenya
|
N/A | |
Completed |
NCT03098329 -
Check it: A New Approach to Controlling Chlamydia Transmission in Young People
|
N/A | |
Completed |
NCT01836445 -
Keep It Up! 2.0: A Comparison of Two Online HIV Intervention Programs for Young Men Who Have Sex With Men
|
N/A |