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Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study

Overall Patient Care in a Montpelier Sexual Health Center (CeGIDD). Response Rate to Ceftriaxone 1g IM in Gonorrhoea : a French Retrospective Monocentric Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04902560
Acronym
GONOCEF
Enrollment
120
Registered
2021-05-26
Start date
2021-05-01
Completion date
2021-08-01
Last updated
2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gonorrhea

Keywords

Neisseria gonorrhoea, Ceftriaxone, Treatment

Brief 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. 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.

Interventions

None listed

Sponsors

University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

\- patient's refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Response rate to Ceftriaxone 1g IM in Gonorrhoea.day 1Evaluated by a test of cure (TOC) which must be negative 15 days after the subject received the treatment (ceftriaxone).

Secondary

MeasureTime frameDescription
Concordance rate with positive PCRday 1Before 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.
Resistance rate to ceftriaxone and AMR description.day 1This measure will be assessed via bacterial cultures
Adverse drug reaction ratesday 1Any adverse effect after treatment will be notified (digestive disorder, headache, phototoxicity, allergic reaction, local reaction at the site of injection…)
Rate of realized TOCday 1Test 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.
Rate of time before realizing the TOC.day 1Sensibility and Specifity may differ depending on the time between treatment and the TOC.
Rate of untreated patient despite having a positive test for gonorrhea (lost to follow-up)day 1Patient 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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026