GonorrheaGONOCEFNCT04902560
Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study
An observational study of Gonorrhea, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea. Patients wanting STI screening can consult either they are symptomatic or not. If they are symptomatic, they can be treated immediately. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gonorrhea
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- 1 May 2021to 1 Aug 2021
- 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: Patient Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier
Who may be able to join
- Aged more than 18 years old
- Non-opposition form given to the subject
- Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier
Who cannot join
- patient's refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study
Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.
Patients wanting STI screening can consult either they are symptomatic or not.
Read more
If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.
Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.
After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.
Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.
Compliance to current recommandation at CeGIDD Montpellier has never been evaluated.
This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.
- Conditions
- Gonorrhea
- Keywords
- Neisseria gonorrhoea, Ceftriaxone, Treatment
- Medical subject headings
- Gonorrhea
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate to Ceftriaxone 1g IM in Gonorrhoea.
Evaluated by a test of cure (TOC) which must be negative 15 days after the subject received the treatment (ceftriaxone).
Measured: day 1
Secondary outcomes (6)
Adverse drug reaction rates
Any adverse effect after treatment will be notified (digestive disorder, headache, phototoxicity, allergic reaction, local reaction at the site of injection…)
Measured: day 1
Concordance rate with positive PCR
Before getting the treatment, all patients should have been sampled for bacterial culture according to current recommendation. Respect of the recommendation will be assessed by this outcome.
Measured: day 1
Resistance rate to ceftriaxone and AMR description.
This measure will be assessed via bacterial cultures
Measured: day 1
Rate of untreated patient despite having a positive test for gonorrhea (lost to follow-up)
Patient compliance may be lacking in sexual health center and non-compliance participate in STI spreading.
Subject not looking for their results after being tested positive for gonorrhea will be notified by phone call. The necessity of calling the patient will be notified in the study.
If the subject does not attend the medical consultation for treatment, he will be consider as lost to follow-up.
Measured: day 1
Rate of realized TOC
Test of cure (TOC) is a PCR test realized at the previous positive site of contamination, approximately 14 days after treatment, in order to confirm the efficacity of treatment.
Measured: day 1
Rate of time before realizing the TOC.
Sensibility and Specifity may differ depending on the time between treatment and the TOC.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 May 2021
- Primary completion1 Jun 2021
- Study completion1 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonorrheaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Du Thanh Aurelie, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04902560
- Sponsor's protocol ID
- RECHMPL21_0301
- Acronym
- GONOCEF
- Status last verified
- Oct 2021
- First submitted
- 18 May 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study
- ClinicalTrials.gov ID
- NCT04902560
- Acronym / sponsor ID
- GONOCEF / RECHMPL21_0301
- Conditions
- Gonorrhea
- Keywords
- Neisseria gonorrhoea, Ceftriaxone, Treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Aug 2021 (actual)
- First posted
- 26 May 2021 (actual)
- 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.
Sexual health centers (CeGIDD, in France) manage the majority of STI in France, especially gonorrhea.
Patients wanting STI screening can consult either they are symptomatic or not.
If they are symptomatic, they can be treated immediately. If they are not symptomatic, they must come back seven days after in order to get their results and to be treated if necessary.
Before any treatment for gonorrhea, subjects should be sampled for bacterial culture in order to perform AMR surveillance.
After every treatment for gonorrhea, subjects should realized a test of cure (TOC) according to current recommandation.
Response rate to ceftriaxone 1g IM for treating gonorrhea has never been evaluated in France while being used widely over the past months.
Compliance to current recommandation at CeGIDD Montpellier has never been evaluated.
This study will assess the response rate to ceftriaxone 1g IM as gonorrhea treatment by realizing a test of cure 14 days after each treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier
Key inclusion criteria (3 listed)
- Aged more than 18 years old
- Non-opposition form given to the subject
- Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier
Key exclusion criteria (1 listed)
- patient's refusal to participate
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
Response rate to Ceftriaxone 1g IM in Gonorrhoea.
Time frame: day 1
Evaluated by a test of cure (TOC) which must be negative 15 days after the subject received the treatment (ceftriaxone).
6 secondary outcomes
Adverse drug reaction rates
Time frame: day 1
Concordance rate with positive PCR
Time frame: day 1
Resistance rate to ceftriaxone and AMR description.
Time frame: day 1
Rate of untreated patient despite having a positive test for gonorrhea (lost to follow-up)
Time frame: day 1
Rate of realized TOC
Time frame: day 1
Rate of time before realizing the TOC.
Time frame: day 1
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 19 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
Du Thanh Aurelie study director
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gonorrhea, run by University Hospital, Montpellier at 1 site in France.
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 3 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 19 Oct 2021. 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 France. 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?
Response rate to Ceftriaxone 1g IM in Gonorrhoea. (time frame: day 1). 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 19 Oct 2021.