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Completed

NCT Number: NCT04902560

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Response rate to Ceftriaxone 1g IM in Gonorrhoea.

    Time frame: day 1

    Evaluated by a test of cure (TOC) which must be negative 15 days after the subject received the treatment (ceftriaxone).

Secondary outcomes

  1. Adverse drug reaction rates

    Time frame: day 1

    Any adverse effect after treatment will be notified (digestive disorder, headache, phototoxicity, allergic reaction, local reaction at the site of injection…)

  2. Concordance rate with positive PCR

    Time frame: 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.

  3. Resistance rate to ceftriaxone and AMR description.

    Time frame: day 1

    This measure will be assessed via bacterial cultures

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

    Time frame: 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.

  5. Rate of realized TOC

    Time frame: 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.

  6. Rate of time before realizing the TOC.

    Time frame: day 1

    Sensibility and Specifity may differ depending on the time between treatment and the TOC.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: GONOCEF

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 26, 2021
Registry last updated
Oct 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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