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Compares treatment options for Diarrhea
Official title Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
ClinicalTrials.gov ID: NCT07285785
What this study is testing
What is Rifaximin 200 mg Tablet?
Rifaximin 200 mg Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diarrhea.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria. It will also learn about the safety and effectiveness of rifaximin when given with oral rehydration therapy (ORT) compared with ORT alone.
- Phase 4: studies an already-approved treatment
- 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 6 to 12
You may be able to join if
- Consent and assent are appropriately obtained prior to any study related activities, including discontinuation of any prohibited medications (people...
- Subject is between 6 to 11 (and 11 months) years of age, inclusive, and weighs at least 15 kg (33 lbs) at Screening.
- Females of childbearing (reproductive) potential must have a negative urine and serum pregnancy test at Screening and agree to use a highly effective...
- Subject has diarrhea of suspected bacterial etiology defined by:
- At least 3 unformed stools in the last 24 hours prior to Screening.
You likely can't join if
- Subject has a history of chronic diarrhea.
- Subject is unable to eat or drink.
- Subject has at least one of the following signs or symptoms:
- Presence of fever \>39°C (\>102.2°F).
- Presence of frank blood in stool.
- Subject has taken \>2 doses of anti-diarrheal therapies in the 24 hours prior to randomization.
See the full eligibility criteria
- Consent and assent are appropriately obtained prior to any study related activities, including discontinuation of any prohibited medications (people must sign an assent for the study and a parent or a legal guardian...
- Subject is between 6 to 11 (and 11 months) years of age, inclusive, and weighs at least 15 kg (33 lbs) at Screening.
- Females of childbearing (reproductive) potential must have a negative urine and serum pregnancy test at Screening and agree to use a highly effective method of contraception throughout their participation in the study...
- Subject has diarrhea of suspected bacterial etiology defined by:
- At least 3 unformed stools in the last 24 hours prior to Screening.
- A fever ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) or has had a fever of ≥ 100.4°F (38°C) and ≤ 102.2°F (39°C) at any time since the development of abdominal pain or diarrhea.
- Illness for less than 96 hours at Screening.
- Parent or legal guardian and subject, when applicable based on aged, are capable of understanding the requirements of the study and willing to comply with all study procedures and visits.
- Subject has a history of chronic diarrhea.
- Subject is unable to eat or drink.
- Subject has at least one of the following signs or symptoms:
- Presence of fever \>39°C (\>102.2°F).
- Presence of frank blood in stool.
- Subject has taken \>2 doses of anti-diarrheal therapies in the 24 hours prior to randomization.
- Subject has taken any oral antimicrobial drug within 14 days of randomization.
- Subject has an unstable medical condition, in the opinion of the Investigator, (including, but not limited to, evidence of severe dehydration noted by tachycardia, abnormal blood pressure, or decreased skin turgor) at...
- Subject has known, clinically significant hepatic disease manifested by twice the age and sex-adjusted upper limit of normal (2 × ULN) for any of the following liver function tests: alanine aminotransferase, aspartate...
- Subject has known, clinically significant renal disease (eg, 1.5 × ULN of serum creatinine or 2 × ULN of blood urea nitrogen levels).
- Subject has serum sodium of ≥150 mEq/L and serum potassium ≤3.0 mEq/L.
- Subject has a known hypersensitivity or allergy to Xifaxan®, rifampin, rifamycin-derived antibiotics, or any of the components of the rifaximin (Xifaxan®) formulations used in this study.
- Subject is pregnant or lactating or plans to become pregnant during the study.
- Subject has had a previous history of malignancy.
- Subject has a history of tuberculosis infection and/or has received treatment for tuberculosis infection.
- Subject has any concurrent illness, disability or circumstance that may affect the interpretation of clinical data, could cause noncompliance with treatment or visits or otherwise contraindicates participation in this...
- Subject has had significant blood loss within the 30 days prior to the Screening visit which prevents the collection of the blood volume required for this study.
- Subject has participated in an investigational drug or device study within the 30 days prior to randomization.
- Subject's parent or legal guardian, or an immediate family member is an employee of the site that is directly involved in the management, administration, or support of this study.
- Subject and/or legal guardian is unwilling or unable to comply with the study protocol for any other reason.
- Subject has a serum glucose level at screening that deviates from the reference range established by the central laboratory.
- Subject is taking a concomitant medication that is a P-glycoprotein (P-gp) inhibitor.
- Subject is taking warfarin for a pre-existing condition.
The study team makes the final eligibility decision.
Where it's taking place
- Hialeah, Florida, United States
- Miami, Florida, United States
- Rosharon, Texas, United States
- Richmond, Virginia, United States
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, 6 years to 12 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hialeah, Florida, United States; Miami, Florida, United States; Rosharon, Texas, United States; Richmond, Virginia, United States. 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.