Patients with STEC Infections - The HIKO STEC Study

November 4th, 2024 was the official intervention arm “crossover” date for the NIH-funded HIKO STEC trial being conducted at Cincinnati Children’s. As such, we wanted to send out some reminders about Shiga toxin producing E. coli (STEC) and the new “Hyperhydration” arm of the study.

Please see the Clinical Practice Support Tool (CPST) on bloody diarrhea caused by STEC infections, including fast facts, assessment information, outpatient management tips, and recommendations on when to refer to the emergency department. 

HIKO STEC is a phase III, multinational, multicenter, embedded, cluster-randomized, crossover trial to compare early aggressive intravenous fluid administration (hyperhydration) with conservative fluid management as treatment for STEC-infected children. Patients with confirmed high-risk STEC or early HUS may be eligible for participation in this study, which also involves data collection and optional biospecimen collection. We are finishing up the traditional/conservative fluid management arm of the trial, which emphasizes a traditional amount of IV fluids, close monitoring (at home or in hospital), and providing supportive care for HUS complications as early as possible. Switching to the Hyperhydration arm will involve treating all children with high-risk STEC (presence of bloody diarrhea and/or Shiga toxin 2 positive) with rapid reversal of dehydration, 2x maintenance fluid administration, daily labs, and close monitoring while admitted to the hospital. In general, we recommend sending your patients with positive STEC stools to the ED for a clinical and laboratory evaluation (preferably within 24 hours), particularly if they are having grossly blood stools.  

If you have a patient with STEC and would like to seek guidance on how to treat them, please feel free to contact Dr. David Schnadower (study principal investigator) at (314) 780-8378 or david.schnadower@cchmc.org. If you have any questions about the HIKO STEC trial, the study coordinator, McKayla Schloemer, can be reached at (513) 803-9134 or mckayla.schloemer@cchmc.org