COTRIM-HIGH - Efficacy of daily prophylaxis with Cotrimoxazole 800/160mg on the occurrence of bacterial infections at six months after renal transplantation

Conditions

bacterial infection, kidney transplant

Brief summary

The occurrence of any type of bacterial infection between M1 and M6 after kidney transplantation.

Detailed description

Number of any type of bacterial infections between M1 and M6 after renal transplantation., Hospitalized for bacterial infectious cause between M1 and M6, Occurrence of serious bacterial infections between M1 and M6, Occurrence of non-bacterial infection between M1 and M6, Occurrence of graft loss and death and its cause(s) until M6, Occurrence of severe and non-severe adverse reaction., Analyses of the TTV PCR at day of randomization (DR) and M1, Individual pharmacokinetic parameters for cotrimoxazole (minimum (Cmin) and maximum (Cmax) concentrations, area under curve (AUC))., Analysis of impact of implementing antimicrobial prophylaxis on gut microbiota in kidney transplantation, Analysis of bacterial susceptibility of cotrimoxazole among pathogens isolated during each treated bacterial infection

Related papers

No related papers found yet.

Interventions

DRUGBACTRIM

DRUGcomprimé sécable

DRUGCOTRIMOXAZOLE TEVA 800 mg/160 mg

DRUGcomprimé

DRUGBACTRIM FORTE

DRUGSULFAMETHOXAZOLE AND TRIMETHOPRIM

DRUGBactrim 400 mg/80 mg tabletter

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The occurrence of any type of bacterial infection between M1 and M6 after kidney transplantation.	—

Secondary

Measure	Time frame
Number of any type of bacterial infections between M1 and M6 after renal transplantation., Hospitalized for bacterial infectious cause between M1 and M6, Occurrence of serious bacterial infections between M1 and M6, Occurrence of non-bacterial infection between M1 and M6, Occurrence of graft loss and death and its cause(s) until M6, Occurrence of severe and non-severe adverse reaction., Analyses of the TTV PCR at day of randomization (DR) and M1, Individual pharmacokinetic parameters for cotrimoxazole (minimum (Cmin) and maximum (Cmax) concentrations, area under curve (AUC))., Analysis of impact of implementing antimicrobial prophylaxis on gut microbiota in kidney transplantation, Analysis of bacterial susceptibility of cotrimoxazole among pathogens isolated during each treated bacterial infection	—

Measure

Time frame

Number of any type of bacterial infections between M1 and M6 after renal transplantation., Hospitalized for bacterial infectious cause between M1 and M6, Occurrence of serious bacterial infections between M1 and M6, Occurrence of non-bacterial infection between M1 and M6, Occurrence of graft loss and death and its cause(s) until M6, Occurrence of severe and non-severe adverse reaction., Analyses of the TTV PCR at day of randomization (DR) and M1, Individual pharmacokinetic parameters for cotrimoxazole (minimum (Cmin) and maximum (Cmax) concentrations, area under curve (AUC))., Analysis of impact of implementing antimicrobial prophylaxis on gut microbiota in kidney transplantation, Analysis of bacterial susceptibility of cotrimoxazole among pathogens isolated during each treated bacterial infection

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Outcome results

None listed