InfectionPhase 3NCT01471392
Identigene STD Test Collection Kit Validation Study
A Phase 3 study testing STD Diagnostic Kit (Identigene) in people with Infection, run by Identigene at 1 site in United States.
Trial summary
The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testing laboratory. Read more about this study
- Who is it for?
- Ages 14 years and olderHealthy volunteers can take part
- Conditions the study is for
- Infection
- What is being tested?
- STD Diagnostic Kit (Identigene)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Jun 2014
- Phase
- Phase 3
- 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 14 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Symptomatic females or males, age 14 or older, who present at a participating clinic with symptoms consistent with Chlamydia trachomatis or Neisseria gonorrhoeae infection, or
- Asymptomatic females or males, age 14 or older, who present at a participating clinic and who suspect that they have CT and/or NG, or are considered at high risk of exposure (e.g., sexual partner that tests positive for CT, or NG, multiple sexual partners, ect.),
- Individuals who are capable of understanding and agree to fulfill the requirements of the protocol.
- Individuals who have signed the IRB approved informed consent form.
Who cannot join
- Individuals with physical or mental inability that, in the opinion of the investigator can interfere with the subject's ability to follow the Identigene STD Test Collection Kit instructions,
- Individuals who are currently being treated for CT or NG or who are currently receiving antibiotics or have received antibiotics within the last 28 days, and
- Individuals who are suspected of being victims of sexual abuse or nonconsensual contact of a sexual nature within the previous 6 months or who are part of an ongoing sexual abuse legal case.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
John Hopkins University
Baltimore, Maryland
Charlotte Gaydos, MD, 410-614-0932, cgaydos@jhmi.edu
Patricia Buist, 410-614-0932, cgaydos@jhmi.edu
About this study
The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testing laboratory. It is expected that this method will aid in detection of CT and NG and that offering a method of self-collection of a male urine or female vaginal swab specimen will encourage testing for CT and NG and improve the overall detection of reporting of these STDs by allowing persons who suspect they have the infection to be tested in a discrete and confidential manner. The reporting of CT and NG are underestimated and many subjects will not visit a clinic or obtain treatment if gone undetected. Thus, allowing a self-collection kit that is more convenient may result in improved reporting, identification of CT and NG positive individuals, and subsequent treatment to help prevent the spread of these diseases.
The purpose of this study is to demonstrate that the Identigene STD Test Collection Kit and labeled instructions for use instructions provide test results that are concordant (at least 95% or better) with test results obtained using the Gen-Probe APTIMA Combo 2 specimen collection and transport methods performed under the supervision of a healthcare provider. The laboratory technology and test method used for the IDTG-100.
Read the detailed description
This is a multicenter study involving asymptomatic and symptomatic subjects who are at risk or suspect possible exposure to CT and/or NG. Approximately five (5) clinics will participate in the study. The clinics selected will be located in diverse geographical regions in order to represent populations with both high and low incidences of CT and NG and to represent different extremes in climate. The initial phase of the study enrolled approximately 500 qualifying subjects. An interim analysis was performed to determine whether changes in the study protocol were necessary. Changes to the protocol were identified and are incorporated in this amendment (amendment 4) of the study protocol. Specifically, males in the study will still collect urine specimens whereas women will now self-collect a vaginal swab specimen. Study subjects will only undergo one clinic visit rather than two as indicated in prior versions of the study protocol. The proposed study phases outlined in this amendment of the study protocol will include at least 200 qualifying subjects with intermittent suspension of the study to allow data analysis. The present study will continue until 200 CT positive test results (approximately 100 male and 100 female) are obtained. Of these 200 positive results, approximately 50% will be from symptomatic subjects and 50% from asymptomatic subjects. Since the positivity rate is presumably lower for asymptomatic subjects, the ration of symptomatic to asymptomatic subject enrollment for each study phase will be determined by the sponsor and will be made known in writing to each study site.
It is expected that approximately 3,000 subjects will be required to meet the overall study objectives. It is anticipated that the total number of subjects enrolled for testing throughout the study will yield approximately 30 positive NG samples (approximately 15 males and 15 females) with no requirement for a specific ratio of symptomatic to asymptomatic subjects. Subjects who are at high risk of exposure or suspect exposure to CT or NG, but are not currently being treated, will be recruited for enrollment.
- Conditions
- Infection
- Being tested
- STD Diagnostic Kit (Identigene)
- Keywords
- Identigene, STD Test, Chlamydia, Gonorrhoeae, APTIMA, Sexually Transmitted Disease
- Medical subject headings
- Infections, Chlamydia Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STD Diagnostic Kit (Identigene)Device
Also called Identigene STD Test Collection Kit
The Identigene STD Test Collection Kit is an at-home kit that allows individuals to utilize the Gen-Probe technology to test for CT and NG in privacy and in a more convenient manner. The primary technology is the approved Gen-Probe APTIMA Combo 2 assay, which is repackaged into the Identigene kit for use by consumers. As such, the laboratory technology and testing method is identical to that of the Gen-Probe APTIMA Combo 2 assay, which has been cleared for in vitro diagnostic use.
| Study group | Role | What they receive |
|---|---|---|
| Identigene STD Test Kit Arm | Experimental | Single-Arm trial where the group will complete the Identigene STD Test Kit at home and these results will be compared with the results from testing in the clinic with the Gen-Probe APTIMA kit. The subject will only be informed of the results from the approved test (Gen-Probe APTIMA) that is done in the clinic. Receives: Device: STD Diagnostic Kit (Identigene) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the Identigene STD Test Collection Kit in comparison to the Gen-Probe Aptima Combo 2 Assay
Demonstration of the effectiveness of the Identigene STD Test Collection Kit based on the percentage of concordant positive and negative results as compared to the Gen-Probe APTIMA Combo 2 assay conducted at an STD clinic.
Measured: 1 day
Secondary outcomes (1)
Evaluation of the Identigene STD Test Collection Kit instructions.
To determine if the instructions of the Identigene STD Test Collection Kit are adequate for proper specimen self-collection and specimen submission to the laboratory for processing.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Identigene
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRI Lifetree Clinical Research
- Responsible party
- Sponsor
- Investigators
- Mike Smith, Study director, Lifetree Clinical ResearchLars Mouritsen, PhD, Study chair, Identigene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01471392
- Sponsor's protocol ID
- IDTG-100
- Status last verified
- May 2013
- First submitted
- 10 Nov 2011
- Last updated
- 3 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identigene STD Test Collection Kit Validation Study
- ClinicalTrials.gov ID
- NCT01471392
- Acronym / sponsor ID
- IDTG-100
- Conditions
- Infection
- Keywords
- Identigene, STD Test, Chlamydia, Gonorrhoeae, APTIMA, Sexually Transmitted Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- IdentigeneIndustry (pharma, biotech, devices)
- Collaborators
- CRI Lifetree Clinical Research
- Study start
- Nov 2011
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 15 Nov 2011 (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.
The overall goal of the present study is to provide evidence of concordant test results using the Identigene STD Test Collection Kit for self-collection and transport of specimens to a qualified testing laboratory. It is expected that this method will aid in detection of CT and NG and that offering a method of self-collection of a male urine or female vaginal swab specimen will encourage testing for CT and NG and improve the overall detection of reporting of these STDs by allowing persons who suspect they have the infection to be tested in a discrete and confidential manner. The reporting of CT and NG are underestimated and many subjects will not visit a clinic or obtain treatment if gone undetected. Thus, allowing a self-collection kit that is more convenient may result in improved reporting, identification of CT and NG positive individuals, and subsequent treatment to help prevent the spread of these diseases.
The purpose of this study is to demonstrate that the Identigene STD Test Collection Kit and labeled instructions for use instructions provide test results that are concordant (at least 95% or better) with test results obtained using the Gen-Probe APTIMA Combo 2 specimen collection and transport methods performed under the supervision of a healthcare provider. The laboratory technology and test method used for the IDTG-100.
Detailed description
This is a multicenter study involving asymptomatic and symptomatic subjects who are at risk or suspect possible exposure to CT and/or NG. Approximately five (5) clinics will participate in the study. The clinics selected will be located in diverse geographical regions in order to represent populations with both high and low incidences of CT and NG and to represent different extremes in climate. The initial phase of the study enrolled approximately 500 qualifying subjects. An interim analysis was performed to determine whether changes in the study protocol were necessary. Changes to the protocol were identified and are incorporated in this amendment (amendment 4) of the study protocol. Specifically, males in the study will still collect urine specimens whereas women will now self-collect a vaginal swab specimen. Study subjects will only undergo one clinic visit rather than two as indicated in prior versions of the study protocol. The proposed study phases outlined in this amendment of the study protocol will include at least 200 qualifying subjects with intermittent suspension of the study to allow data analysis. The present study will continue until 200 CT positive test results (approximately 100 male and 100 female) are obtained. Of these 200 positive results, approximately 50% will be from symptomatic subjects and 50% from asymptomatic subjects. Since the positivity rate is presumably lower for asymptomatic subjects, the ration of symptomatic to asymptomatic subject enrollment for each study phase will be determined by the sponsor and will be made known in writing to each study site.
It is expected that approximately 3,000 subjects will be required to meet the overall study objectives. It is anticipated that the total number of subjects enrolled for testing throughout the study will yield approximately 30 positive NG samples (approximately 15 males and 15 females) with no requirement for a specific ratio of symptomatic to asymptomatic subjects. Subjects who are at high risk of exposure or suspect exposure to CT or NG, but are not currently being treated, will be recruited for enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Identigene STD Test Kit Arm | Experimental | Device: STD Diagnostic Kit (Identigene)Single-Arm trial where the group will complete the Identigene STD Test Kit at home and these results will be compared with the results from testing in the clinic with the Gen-Probe APTIMA kit. The subject will only be informed of the results from the approved test (Gen-Probe APTIMA) that is done in the clinic. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Symptomatic females or males, age 14 or older, who present at a participating clinic with symptoms consistent with Chlamydia trachomatis or Neisseria gonorrhoeae infection, or
- Asymptomatic females or males, age 14 or older, who present at a participating clinic and who suspect that they have CT and/or NG, or are considered at high risk of exposure (e.g., sexual partner that tests positive for CT, or NG, multiple sexual partners, ect.),
- Individuals who are capable of understanding and agree to fulfill the requirements of the protocol.
- Individuals who have signed the IRB approved informed consent form.
Key exclusion criteria (3 listed)
- Individuals with physical or mental inability that, in the opinion of the investigator can interfere with the subject's ability to follow the Identigene STD Test Collection Kit instructions,
- Individuals who are currently being treated for CT or NG or who are currently receiving antibiotics or have received antibiotics within the last 28 days, and
- Individuals who are suspected of being victims of sexual abuse or nonconsensual contact of a sexual nature within the previous 6 months or who are part of an ongoing sexual abuse legal case.
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 |
|---|---|---|
| STD Diagnostic Kit (Identigene)Also: Identigene STD Test Collection KitThe Identigene STD Test Collection Kit is an at-home kit that allows individuals to utilize the Gen-Probe technology to test for CT and NG in privacy and in a more convenient manner. The primary technology is the approved Gen-Probe APTIMA Combo 2 assay, which is repackaged into the Identigene kit for use by consumers. As such, the laboratory technology and testing method is identical to that of the Gen-Probe APTIMA Combo 2 assay, which has been cleared for in vitro diagnostic use. | Device | Identigene STD Test Kit Arm |
Primary outcome
Effectiveness of the Identigene STD Test Collection Kit in comparison to the Gen-Probe Aptima Combo 2 Assay
Time frame: 1 day
Demonstration of the effectiveness of the Identigene STD Test Collection Kit based on the percentage of concordant positive and negative results as compared to the Gen-Probe APTIMA Combo 2 assay conducted at an STD clinic.
1 secondary outcome
Evaluation of the Identigene STD Test Collection Kit instructions.
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2013.
- CDC Information on GonorrheaLink provided by the sponsor.
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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.
Mike Smith study director
Lifetree Clinical Research
Lars Mouritsen, PhD study chair
Identigene
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing STD Diagnostic Kit (Identigene) in people with Infection, run by Identigene at 1 site in United States.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 3 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Smith (801-859-7818, mikes@lifetreeresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of the Identigene STD Test Collection Kit in comparison to the Gen-Probe Aptima Combo 2 Assay (time frame: 1 day). 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 3 Jun 2013.