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

NCT04902560 | Completed

• 1 other identifier: RECHMPL21_0301
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonorrhea

Keywords

Neisseria gonorrhoea; Ceftriaxone; Treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Adverse drug reaction rates

  day 1

• Concordance rate with positive PCR

  day 1

• Resistance rate to ceftriaxone and AMR description.

  day 1

• Rate of untreated patient despite having a positive test for gonorrhea (lost to follow-up)

  day 1

• Rate of realized TOC

  day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- patient's refusal to participate

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Gonorrhea

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Sexually Transmitted Diseases, Bacterial; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases; Urogenital Diseases

Study Officials

• Du Thanh Aurelie

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 26, 2021
• Study Start: May 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: August 1, 2021
• Last Updated: October 19, 2021

Record last verified: 2021-10

Locations

FR (1)