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

Gonorrhea Clinical Trial

— GONOCEF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902560
• Other study ID #: RECHMPL21_0301
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: October 2021
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 1, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gonorrhea

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	day 1
Secondary	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…)	day 1
Secondary	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.	day 1
Secondary	Resistance rate to ceftriaxone and AMR description.	This measure will be assessed via bacterial cultures	day 1
Secondary	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.	day 1
Secondary	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.	day 1
Secondary	Rate of time before realizing the TOC.	Sensibility and Specifity may differ depending on the time between treatment and the TOC.	day 1