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

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.

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 Overview

• Status: Completed
• Conditions: Gonorrhea

• Study Type: Observational
• Enrollment (Actual): 120

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient Having at least one exam positive for Gonorrhoea (PCR or Culture), realised in CeGIDD de Montpellier

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Resistance rate to ceftriaxone and AMR description.	This measure will be assessed via bacterial cultures	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.	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.	day 1
Rate of time before realizing the TOC.	Sensibility and Specifity may differ depending on the time between treatment and the TOC.	day 1

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Study Director: Du Thanh Aurelie, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: May 18, 2021
• First Submitted That Met QC Criteria: May 25, 2021
• First Posted (Actual): May 26, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2021
• Last Update Submitted That Met QC Criteria: October 18, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Treatment; Ceftriaxone; Neisseria gonorrhoea
• Additional Relevant MeSH Terms: Infections; Communicable Diseases; Sexually Transmitted Diseases; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Neisseriaceae Infections; Sexually Transmitted Diseases, Bacterial; Gonorrhea
• Other Study ID Numbers: RECHMPL21_0301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No