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Temocillin Compared with Ceftriaxone for Gonorrhea Infection in Adults

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying Neisseria gonorrhoeae infection, which is a gonorrhea infection. The study compares temocillin given by intravenous injection or intramuscular injection with the usual treatment, ceftriaxone given by intramuscular injection. The purpose of the study is to see whether temocillin works as well as the standard treatment for this infection.

People in the study receive one of the study treatments and are followed over time. After treatment, there are checkups during the study to see how the infection is responding and to watch for any side effects. The study also looks at how well the treatment is tolerated and how people feel about the treatment after receiving it. Some samples may be tested during the study to check for signs of the infection in the body.

The trial is designed to compare the results of temocillin with the usual treatment in different body sites where gonorrhea can be found, such as the urine, vagina, throat, or anus. It also monitors safety, including unwanted effects and serious health problems, during the follow-up period.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Day 1: treatment and first study checks

    You receive one study treatment on day 1. The treatment is either temocillin or ceftriaxone.

    If you receive temocillin, the dose is 2 g given as an intramuscular injection or as an intravenous administration. Intramuscular injection means an injection into a muscle. Intravenous administration means the medicine is given into a vein.

    If you receive ceftriaxone, the dose is 1 g given as an intramuscular injection. This medicine contains ceftriaxone sodium and lidocaine hydrochloride.

    After the injection, you answer 5 questions during the consultation about your satisfaction and perception of the treatment.

    On day 1, samples are taken to check the infection and to study the bacteria. These checks include samples from the urine or vagina, throat, and anus, depending on the infected sites.

    On day 1, the study also checks the presence of esbl-e in the rectum. Esbl-e means certain bacteria that can resist some antibiotics.

    On day 1, the study may also examine the bacteria causing the infection, including their type and any signs of resistance to treatment.

  2. Step 2

    Day 21: follow-up visit and main outcome check

    On day 21, you return for the main follow-up check.

    A sample is taken from each infected site to see whether the infection is cleared. The sites are urine or vagina, throat, and anus.

    The main result of the study is based on whether the test for Ng is negative at day 21. Ng means Neisseria gonorrhoeae, the bacteria that cause the infection.

    The study checks whether treatment was successful at each infected site separately.

    You again answer 5 questions during the consultation about your satisfaction and perception of the treatment.

    On day 21, the study again checks esbl-e rectal colonization and may examine the bacteria present in the throat, anus, urine, or vagina.

    On day 21, the study may also repeat the analysis of the infection bacteria and any resistance markers.

  3. Step 3

    Month 3: later follow-up check

    At m3, which means 3 months after treatment, another follow-up check is performed.

    The study checks for adverse effects, which means unwanted medical problems that happen during or after treatment.

    The study also checks for serious adverse events, which are more severe unwanted medical problems.

    At m3, the study again checks esbl-e rectal colonization.

    At m3, the study may also examine the bacteria in the throat, anus, urine, or vagina.

Who can join the trial?

8 criteria

  • Be 18 years old or older.
  • Have a positive PCR test for Neisseria gonorrhoeae from urine, vagina, throat, and/or anus. A PCR test is a laboratory test that looks for the germ’s genetic material.
  • Have an asymptomatic infection, meaning no symptoms are present.
  • Have understood the entire study and agree to follow its rules and restrictions.
  • If the patient is a woman who can become pregnant and is sexually active, use an effective birth control method during the study and for 90 days after the last dose of the study treatment.
  • Sign the informed consent form, which means giving written permission to take part in the study after receiving the study information.
  • Be covered by a Social Security scheme or State Medical Aid, unless an exemption applies.
  • Speak French, English, or Spanish.

Who cannot join the trial?

16 criteria

  • You cannot take part if you have a known allergy to penicillin, temocillin, ceftriaxone, or other beta-lactam antibiotics (a family of antibiotics that includes penicillins and cephalosporins), if the allergy is severe, or if you are allergic to lidocaine (a local numbing medicine).
  • You cannot take part if you have known complete heart block, which is a serious problem where the electrical signals in the heart do not pass normally.
  • You cannot take part if you have a known hypersensitivity to lidocaine or to other amide-type anesthetics (a group of medicines used to numb an area).
  • You cannot take part if there is a clinical suspicion of hypovolemia, which means a low amount of fluid or blood in the body.
  • You cannot take part if you are already taking, or need to start, antibiotic treatment for another bacterial infection, except for doxycycline used as post-exposure prevention after possible infection exposure.
  • You cannot take part if your body mass index (BMI) is greater than 35 kg/m². BMI is a measure based on height and weight.
  • You cannot take part if you have had another antibiotic treatment within the last month, except for doxycycline used as post-exposure prevention.
  • You cannot take part if you have a complicated upper genital infection, meaning a more serious infection in the upper part of the reproductive organs.
  • You cannot take part if you are pregnant or breastfeeding.
  • You cannot take part if you have known kidney problems or liver problems, because these are called renal and hepatic dysfunction.
  • You cannot take part if you are receiving curative anticoagulation, which is blood-thinning treatment used to treat a clot, or if you have a known hemostasis disorder, which is a problem with blood clotting, because this may not allow the medicine to be given by injection into the muscle.
  • You cannot take part if you have taken part in this study before.
  • You cannot take part if you are under legal guardianship, meaning another person has been legally appointed to make decisions for you.
  • You cannot take part if you are currently in another randomized trial or have been in another trial of a medicine or a medical device within the last 3 months.
  • You cannot take part if you are deprived of liberty by a judicial or administrative decision, meaning you are not free to leave because of a legal or administrative order.
  • You cannot take part if you are the investigator, a member of the study team, or a close relative of someone involved in the study.
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Investigated drugs

  • Ceftriaxone

    is the standard treatment used as the comparison in this trial. It is given by injection into a muscle and is used to treat gonorrhea infection. The study compares this usual treatment with temocillin to see whether temocillin works just as well.

  • Temocillin

    is the main study medicine being tested. It is an antibiotic given by injection into a muscle or into a vein. The trial is checking whether temocillin can treat gonorrhea as effectively as the standard treatment.

  • Negaban

    is a brand name for temocillin used in the study. It is given by injection or infusion into a vein. It serves the same role as temocillin in the trial, which is to test whether this antibiotic can clear the infection.

What is already known about the treatment

  • Ceftriaxone

    Ceftriaxone is an antibiotic given by intramuscular injection, and in this trial it is used as the standard comparison treatment; lidocaine hydrochloride is added to make the injection less painful. It is still widely used in medicine and is well described in medical literature as a trusted treatment for many serious bacterial infections, including gonorrhea. It works by blocking the bacterial cell wall from forming properly, which causes the bacteria to break apart and die. Ceftriaxone belongs to the cephalosporin class of antibiotics, which are part of the broader group of beta-lactam antibiotics.

  • Temocillin

    Temocillin is an antibiotic that can be given by intramuscular injection or by intravenous injection or infusion, depending on the product used. It is an established medicine in some countries and is discussed in medical literature mainly for infections caused by certain bacteria, especially some hard-to-treat gram-negative infections and, in this trial, Neisseria gonorrhoeae infection. It works by attaching to proteins that bacteria need to build their cell wall, which stops the wall from forming and leads to bacterial death. Temocillin belongs to the penicillin class of antibiotics and is a beta-lactam antibiotic.

  • Negaban 2 g poudre pour solution injectable/pour perfusion

    Negaban is a brand name of temocillin, given either by intravenous injection or infusion after being prepared from powder. Its medical status and use are the same as temocillin, which is an antibiotic known in the medical literature for treating certain bacterial infections, especially some difficult gram-negative infections and, in this study, gonorrhea. It acts by blocking key bacterial proteins needed to build the cell wall, which weakens and kills the bacteria. Pharmacologically, it is a penicillin-type beta-lactam antibiotic.

Investigated diseases

Neisseria gonorrhoeae infection - A bacterial infection caused by Neisseria gonorrhoeae, a germ that can infect the urethra, cervix, throat, or rectum. It often begins with local irritation, pain, or discharge, but some infections cause few or no symptoms. The infection can remain limited to one site or involve several body sites at the same time. Without effective clearance, it may continue to spread within the infected area and persist over time.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-524475-23-00Protocol codeAPHP251262Estimated enrolment360 patientsSponsorAssistance Publique Hopitaux De Paris

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