GonorrhoeaRaDAR-GoNCT02350907
Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea
An observational study of Gonorrhoea, run by University of Bern at 3 sites in Switzerland.
Trial summary
The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of antimicrobial resistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonorrhoea
- How many people
- 261 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Feb 2015to Aug 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: Adult male and females at risk of gonorrhoea infection.
Who may be able to join
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Participant is literate in German, French, English or Hungarian.
- Participant is at risk for a N. gonorrhoeae infection. This is defined as:
- exhibiting signs/symptoms of a N. gonorrhoeae infection.
- having a sexual partner who has been diagnosed with a N. gonorrhoeae infection.
- participating in high-risk activities for a N. gonorrhoeae infection.
Who cannot join
- Subject does not agree to undergo diagnostic test for gonorrhoea.
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
University Hospital of Bern
Bern, 3010
Ambulatorium Kanonengasse
Zurich, 8004
Checkpoint Zurich
Zurich, 8005
About this study
Official title: Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea: RaDAR-Go
The purpose of this study is to develop a laboratory-based assay that will be a real-time PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of antimicrobial resistance. This study will also determine factors associated with gonorrhoea and describe sexual behaviours of men who have sex with men, to inform parameters for a mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.
- Conditions
- Gonorrhoea
- Keywords
- antimicrobial resistance, point-of-care testing, Neisseria gonorrhoeae
- Medical subject headings
- Gonorrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens
Measured: Day of specimen sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for GonorrhoeaStudies of the same condition, open and under way.
- More trials run by University of BernThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicola Low, Principal investigator, University of Bern, Institute of Social and Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02350907
- Sponsor's protocol ID
- 25/2013
- Acronym
- RaDAR-Go
- Status last verified
- Jul 2019
- First submitted
- 20 Jan 2015
- Last updated
- 16 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Low N, Unemo M, Skov Jensen J, Breuer J, Stephenson JM. Molecular diagnostics for gonorrhoea: implications for antimicrobial resistance and the threat of untreatable gonorrhoea. PLoS Med. 2014 Feb 4;11(2):e1001598. doi: 10.1371/journal.pmed.1001598. eCollection 2014 Feb.
PubMed 24503544Fingerhuth SM, Bonhoeffer S, Low N, Althaus CL. Antibiotic-Resistant Neisseria gonorrhoeae Spread Faster with More Treatment, Not More Sexual Partners. PLoS Pathog. 2016 May 19;12(5):e1005611. doi: 10.1371/journal.ppat.1005611. eCollection 2016 May.
PubMed 27196299Dona V, Kasraian S, Lupo A, Guilarte YN, Hauser C, Furrer H, Unemo M, Low N, Endimiani A. Multiplex Real-Time PCR Assay with High-Resolution Melting Analysis for Characterization of Antimicrobial Resistance in Neisseria gonorrhoeae. J Clin Microbiol. 2016 Aug;54(8):2074-81. doi: 10.1128/JCM.03354-15. Epub 2016 May 25.
PubMed 27225407Low N, Unemo M. Molecular tests for the detection of antimicrobial resistant Neisseria gonorrhoeae: when, where, and how to use? Curr Opin Infect Dis. 2016 Feb;29(1):45-51. doi: 10.1097/QCO.0000000000000230.
PubMed 26658656Dona V, Smid JH, Kasraian S, Egli-Gany D, Dost F, Imeri F, Unemo M, Low N, Endimiani A. Mismatch Amplification Mutation Assay-Based Real-Time PCR for Rapid Detection of Neisseria gonorrhoeae and Antimicrobial Resistance Determinants in Clinical Specimens. J Clin Microbiol. 2018 Aug 27;56(9):e00365-18. doi: 10.1128/JCM.00365-18. Print 2018 Sep.
PubMed 29950339
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Diagnosis of Antibiotic Resistance in Gonorrhoea: RaDAR-Go
- ClinicalTrials.gov ID
- NCT02350907
- Acronym / sponsor ID
- RaDAR-Go / 25/2013
- Conditions
- Gonorrhoea
- Keywords
- antimicrobial resistance, point-of-care testing, Neisseria gonorrhoeae
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 30 Jan 2015 (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 purpose of this study is to develop a laboratory-based assay that will be a real-time PCR test to detect the organism N. gonorrhoeae and its most important genetic markers of antimicrobial resistance. This study will also determine factors associated with gonorrhoea and describe sexual behaviours of men who have sex with men, to inform parameters for a mathematical model of gonorrhoea transmission and antimicrobial resistant gonorrhoea.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult male and females at risk of gonorrhoea infection.
Key inclusion criteria (7 listed)
- Participant is willing and able to give informed consent for participation in the study.
- Male or female, aged 18 years or above.
- Participant is literate in German, French, English or Hungarian.
- Participant is at risk for a N. gonorrhoeae infection. This is defined as:
Key exclusion criteria (1 listed)
- Subject does not agree to undergo diagnostic test for gonorrhoea.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens
Time frame: Day of specimen sampling
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Background: PubMed 24503544Low N, Unemo M, Skov Jensen J, Breuer J, Stephenson JM. Molecular diagnostics for gonorrhoea: implications for antimicrobial resistance and the threat of untreatable gonorrhoea. PLoS Med. 2014 Feb 4;11(2):e1001598. doi: 10.1371/journal.pmed.1001598. eCollection 2014 Feb.
- Background: PubMed 27196299Fingerhuth SM, Bonhoeffer S, Low N, Althaus CL. Antibiotic-Resistant Neisseria gonorrhoeae Spread Faster with More Treatment, Not More Sexual Partners. PLoS Pathog. 2016 May 19;12(5):e1005611. doi: 10.1371/journal.ppat.1005611. eCollection 2016 May.
- Background: PubMed 27225407Dona V, Kasraian S, Lupo A, Guilarte YN, Hauser C, Furrer H, Unemo M, Low N, Endimiani A. Multiplex Real-Time PCR Assay with High-Resolution Melting Analysis for Characterization of Antimicrobial Resistance in Neisseria gonorrhoeae. J Clin Microbiol. 2016 Aug;54(8):2074-81. doi: 10.1128/JCM.03354-15. Epub 2016 May 25.
- Background: PubMed 26658656Low N, Unemo M. Molecular tests for the detection of antimicrobial resistant Neisseria gonorrhoeae: when, where, and how to use? Curr Opin Infect Dis. 2016 Feb;29(1):45-51. doi: 10.1097/QCO.0000000000000230.
- Results publication: PubMed 29950339Dona V, Smid JH, Kasraian S, Egli-Gany D, Dost F, Imeri F, Unemo M, Low N, Endimiani A. Mismatch Amplification Mutation Assay-Based Real-Time PCR for Rapid Detection of Neisseria gonorrhoeae and Antimicrobial Resistance Determinants in Clinical Specimens. J Clin Microbiol. 2018 Aug 27;56(9):e00365-18. doi: 10.1128/JCM.00365-18. Print 2018 Sep.
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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.
Nicola Low principal investigator
University of Bern, Institute of Social and Preventive Medicine
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 Gonorrhoea, run by University of Bern at 3 sites in Switzerland.
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 1 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: finished, as of the sponsor's last update on 16 Jul 2019. 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 Switzerland. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Presence of N. gonorrhoeae genetic markers for antimicrobial resistance in clinical specimens (time frame: Day of specimen sampling). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02350907, which also lists 5 linked publications.
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 16 Jul 2019.