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New treatment option 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
- The objective of this study is to determine if early high volume intravenous fluid administration (hyperhydration) may be effective in mitigating or preventing complications of shiga toxin-producing E. coli (STEC) infection in children and adolescents when compared with traditional approaches (conservative fluid management).
- 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
- In order to be eligible to participate in this study (i.e., to be enrolled in the relevant institutional clinical care pathway), an individual must...
- Aged 9.0 months to \<21 years at the time of informed consent.
- Evidence of high-risk STEC infecting pathogen defined by any of the following:
- Bloody diarrhea within the preceding 7 days
- Positive STEC culture OR
You likely can't join if
- All individuals meeting any of the exclusion criteria at baseline will be excluded from study participation.
- Presence of Advanced HUS defined by:
- 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...
See the full eligibility criteria
- In order to be eligible to participate in this study (i.e., to be enrolled in the relevant institutional clinical care pathway), an individual must meet all of the following criteria:
- Aged 9.0 months to \<21 years at the time of informed consent.
- Evidence of high-risk STEC infecting pathogen defined by any of the following:
- 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.
- Presence of Advanced HUS defined by:
- 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's taking place
- 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 - 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?
Study sites include 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 location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.