Temocillin Non-Inferiority Trial Versus Ceftriaxone for Neisseria gonorrhoeae Infections in Adults

The primary objective is to demonstrate the non-inferiority of temocillin 2 g administered intravenously or intramuscularly versus the reference treatment with 1 g intramuscular ceftriaxone in Neisseria gonorrhoeae infection, based on a negative PCR at day 21 in urine, vagina, throat, and/or anus. This outcome is clinically relevant because it assesses microbiological eradication at the infected site. The secondary objectives are to compare treatment efficacy at day 21 according to the infected site, evaluate safety, assess patient satisfaction and perception, examine the impact of the antimicrobial therapies on rectal ESBL-E carriage at day 1, day 21, and month 3, assess changes in throat/anal and urine/vagina microbiota at day 1, day 21, and month 3, and characterize the selected Neisseria gonorrhoeae population through MIC determination to ceftriaxone and temocillin, genotype, clonality, and resistance determinants.

The sponsor did not provide the total number of participants. The trial population included adult male and female patients aged 18 years or older with asymptomatic Neisseria gonorrhoeae infection confirmed by positive PCR from urine, vagina, throat, and/or anus. Selection was based on infection status and the ability to understand the study and provide consent. Relevant lifestyle-related considerations included the requirement for sexually active women of child-bearing potential to use an effective method of birth control throughout the study period and for 90 days after the last dose. The sponsor did not provide additional information on general health status or other population characteristics.

The trial is a multicenter, randomized, controlled, open-label, non-inferiority study with three parallel arms in Neisseria gonorrhoeae infections. The planned study period extends from June 2026 to July 2028. Participants are expected to be involved from screening through the end-of-study assessment at day 21, with additional follow-up to month 3 for selected outcomes. The screening visit is used to confirm eligibility, including age, positive PCR, asymptomatic infection, consent, and other protocol requirements. Treatment is then assigned to compare 2 g temocillin administered intravenously or intramuscularly with 1 g intramuscular ceftriaxone as standard of care. A baseline assessment is performed at day 1 after injection, followed by the day 21 visit to assess therapeutic success by PCR at urine/vagina, throat, and anus, and to collect safety, satisfaction, microbiological, and resistance data. A month 3 follow-up visit is included for adverse events and selected microbiological endpoints. The end-of-study visit occurs at day 21, with additional follow-up procedures continuing to month 3 as specified. Early termination may occur for study discontinuation due to adverse events or other protocol-defined conditions leading to withdrawal from participation.

Temocillin was administered as a 2 g dose by intramuscular injection or by intravenous administration, using a solution for injection/infusion. The study evaluated temocillin sodium as the investigational treatment for gonorrhea infections. The dosing regimen consisted of a single 2 g administration according to the assigned route.

Ceftriaxone was used as the comparator treatment and was administered as a 1 g intramuscular injection. The formulation contained ceftriaxone sodium and lidocaine hydrochloride. This treatment represented the standard-of-care reference in the trial and was used for comparison with temocillin.

Efficacy will be assessed by the proportion of participants with therapeutic success at D21. Therapeutic success is defined as a negative PCR for Neisseria gonorrhoeae at all three sites: urine/vagina, throat, and anus. The primary analysis will compare 2 g intravenous or intramuscular temocillin with 1 g intramuscular ceftriaxone.

Secondary efficacy assessments will include the proportion of participants with therapeutic success at D21 according to each infected site, with therapeutic success defined as a negative PCR at the relevant infection site. Additional assessments include satisfaction/perception evaluated at baseline (D1, after injection) and D21 through five questions asked during consultation. Ng populations, clonality, and resistance determinants, including MIC, ST, and resistance genes, will be analyzed at D1 and D21.