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

Completed

• Conditions: Gonorrhea

• Registration Number: NCT04902560
• Lead Sponsor: University Hospital, Montpellier

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2021-05-18
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-26
• Primary Completion: 2021-06-01
• Study Completion: 2021-08-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-18
• Last Update Posted: 2021-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France