Clinical trial for Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection
Official title Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection
ClinicalTrials.gov ID: NCT05219110
What this study is testing
- What it's testing
- This study aims to find out if giving large amounts of IV fluids early on can prevent or reduce serious complications from the infection.
- Who it's for
- The study is looking for children and teenagers who have been diagnosed with a Shiga toxin-producing E. coli infection.
- What's involved
- Participants will receive high-volume IV fluids instead of the standard amount of fluids usually given for this condition.
- Time commitment
- The source text does not specify the total duration of the study or the number of required visits.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 9 to 21
You may be able to join if
- Aged 9.0 months to \<21 years at the time of informed consent.
- Bloody diarrhea within the preceding 7 days
- Positive STEC culture OR
- Positive antigen/polymerase chain reaction test for toxin/gene type not otherwise specified OR
- Bloody or Non-bloody diarrhea within the preceding 7 days Presumptive diagnosis of HUS
You likely can't join if
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Hematocrit \<30% AND
- Platelet count \<150 x 103/mm3 AND
- Creatinine \> 2.0 mg/dL (177 µmol/L)
- The presence of only 1 or 2 of these criteria will not result in patient exclusion, regardless of how close the 3rd criterion is to meeting the...
- Prior episode of HUS or diagnosis of atypical HUS.
See the full eligibility criteria
- Aged 9.0 months to \<21 years at the time of informed consent.
- Bloody diarrhea within the preceding 7 days
- Positive STEC culture OR
- Positive antigen/polymerase chain reaction test for toxin/gene type not otherwise specified OR
- Bloody or Non-bloody diarrhea within the preceding 7 days Presumptive diagnosis of HUS
- (meeting all 3 HUS criteria - anemia, thrombocytopenia, and renal insufficiency) OR
- Non-bloody or no diarrhea
- Positive STEC culture for high-risk strain (i.e., O103, O104, O111, O113, O121, O145 or O157) OR
- Positive antigen/polymerase chain reaction test Stx2 toxin/gene
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Hematocrit \<30% AND
- Platelet count \<150 x 103/mm3 AND
- Creatinine \> 2.0 mg/dL (177 µmol/L)
- The presence of only 1 or 2 of these criteria will not result in patient exclusion, regardless of how close the 3rd criterion is to meeting the exclusion criteria.
- Prior episode of HUS or diagnosis of atypical HUS.
- Chronic disease limiting fluid volumes administered (e.g. impaired renal, liver, or cardiac function, chronic lung disease).
- Evidence of anuria (i.e., no urine output for \> 24 hours).
- Hypoxemia requiring oxygen therapy
- Hypertensive emergency
- Greater than or equal to 10 days since onset of diarrhea or if no diarrhea then the onset of other symptoms.
- Patients with known pregnancy
- Patients or caregivers with language barriers impairing appropriate conduct of the study protocol.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Little Rock, Arkansas, United States
- La Jolla, California, United States
- Sacramento, California, United States
- Denver, Colorado, United States
- Washington D.C., District of Columbia, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Charleston, South Carolina, United States
- Nashville, Tennessee, United States
- Houston, Texas, United States
+ 6 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 9 months to 21 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Little Rock, Arkansas, United States; La Jolla, California, United States; Sacramento, California, United States; Denver, Colorado, United States; Washington D.C., District of Columbia, United States and 20 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.