Efficacy of Temocillin compared to standard of care in the Treatment of Neisseria gonorrhoeae Infections: A Multicenter Randomized Controlled Non-Inferiority Trial (TEMtoGo).

Conditions

Neisseria gonorrhoeae Infections

Brief summary

Proportion of participants with therapeutic success at D21. Therapeutic success is defined by a negative PCR for Ng at all three sites (urine/vagina, throat and anus) at D21 of treatment.

Detailed description

- Proportion of participants with therapeutic success at D21 according to each infected site urine/vagina, throat or anus). Therapeutic success is defined by a negative PCR for the infection site at day 21 of treatment., - Incidence of clinical and biological adverse effects (AEs), grade 3 or 4 AEs, all-grade AEs, treatment-related adverse events (all grades), study discontinuations due to AEs, and serious adverse events at M3., - Satisfaction/perception evaluated by the patient at baseline (D1, after injection) and D21 (5 questions asked during consultation), - Proportion of ESBL-E rectal colonization at baseline (D1), D21, and M3, - Composition of the throat/anal and urine/vagina microbiota at D1, D21 and M3, - Ng populations, clonality, and analysis of resistance determinants (MIC, ST, resistance genes) at day 1 and D21.

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGCEFTRIAXONE

DRUGTEMOCILLIN

DRUGNegaban 2 g poudre pour solution injectable/pour perfusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of participants with therapeutic success at D21. Therapeutic success is defined by a negative PCR for Ng at all three sites (urine/vagina, throat and anus) at D21 of treatment.	—

Secondary

Measure	Time frame
- Proportion of participants with therapeutic success at D21 according to each infected site urine/vagina, throat or anus). Therapeutic success is defined by a negative PCR for the infection site at day 21 of treatment., - Incidence of clinical and biological adverse effects (AEs), grade 3 or 4 AEs, all-grade AEs, treatment-related adverse events (all grades), study discontinuations due to AEs, and serious adverse events at M3., - Satisfaction/perception evaluated by the patient at baseline (D1, after injection) and D21 (5 questions asked during consultation), - Proportion of ESBL-E rectal colonization at baseline (D1), D21, and M3, - Composition of the throat/anal and urine/vagina microbiota at D1, D21 and M3, - Ng populations, clonality, and analysis of resistance determinants (MIC, ST, resistance genes) at day 1 and D21.	—

Measure

Time frame

- Proportion of participants with therapeutic success at D21 according to each infected site urine/vagina, throat or anus). Therapeutic success is defined by a negative PCR for the infection site at day 21 of treatment., - Incidence of clinical and biological adverse effects (AEs), grade 3 or 4 AEs, all-grade AEs, treatment-related adverse events (all grades), study discontinuations due to AEs, and serious adverse events at M3., - Satisfaction/perception evaluated by the patient at baseline (D1, after injection) and D21 (5 questions asked during consultation), - Proportion of ESBL-E rectal colonization at baseline (D1), D21, and M3, - Composition of the throat/anal and urine/vagina microbiota at D1, D21 and M3, - Ng populations, clonality, and analysis of resistance determinants (MIC, ST, resistance genes) at day 1 and D21.

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Outcome results

None listed