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Clinical Trials in the EU / 2026-526183-20-00
Authorised, not yet recruiting Phase III

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

2026-526183-20-00 · tracked via the Priya Life Science EU tracker
Sponsor
Assistance Publique Hopitaux De Paris
Sponsor type
Hospital/Clinic/Other health care facility
Therapeutic area
Bacterial Infections and Mycoses
Decision date
08/10/2026
Enrollment target
1400
Sites
France

Condition studied

bacterial infection, kidney transplant

Investigational medicinal product(s)

BACTRIMcomprimé sécableCOTRIMOXAZOLE TEVA 800 mg/160 mgcompriméBACTRIM FORTESULFAMETHOXAZOLE AND TRIMETHOPRIMBactrim 400 mg/80 mg tabletter

Every trial of Trimethoprim-sulfamethoxazole across our registers →

Eligibility

Age group
65+ years, 18-64 years
Sex
Female, Male

Primary endpoint

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

Endpoint detail

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

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2026-526183-20-00 on CTIS ↗ ← All trials in the EU