WithdrawnPhase 1

Shiga Toxin Producing Escherichia Coli (STEC) Volume Expansion

Stopped: Funding not obtained.

Canada0Started 2020-05

Plain-language summary

This study will provide feasibility data regarding the conduct of a clinical trail evaluating the use of early aggressive inpatient intravenous rehydration in children with Shiga Toxin producing E. coli infection.

Who can participate

Age range6 Months – 18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age \<18.0 years;
✓. STEC infection \[positive culture OR antigen OR polymerase chain reaction test for Stx/gene\];
✓. Day of illness 1-10: Children who develop HUS will do so by day #14 of illness;8 restricting enrolment to the first 10 days will ensure all participants are at risk of HUS.

Exclusion criteria

✕. Evidence of evolving HUS: A) Hematocrit \<30% OR B) Platelet count \<150 x 109/L;
✕. Responsible physician desires patient admission (therefore unable to randomize);
✕. Unable to contact family within 48 hours of positive stool test;
✕. Patient with history of atypical HUS;
✕. Chronic disease limiting fluid volumes administered (e.g. impaired cardiac function)

What they're measuring

Number of children enrolled in the study protocol

Timeframe: at the end of the 24 month study recruiting period

Trial details

NCT IDNCT03275792

SponsorUniversity of Calgary

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04

View on ClinicalTrials.gov More Hemolytic-Uremic Syndrome trials