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Compares treatment options for Diarrhoea;Acute
Official title Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
ClinicalTrials.gov ID: NCT05677282
What this study is testing
What is Rifaximin 550 MG?
Rifaximin 550 MG is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for diarrhoea;acute.
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 purpose of this study is to compare a single dose of rifaximin with loperamide to the current standard approach of single dose azithromycin with loperamide for the treatment of acute watery traveler's diarrhea (TD). The study requires 1) taking a single dose antibiotic plus loperamide to treat TD, 2) providing blood and stool samples at different time points to evaluate infection and immune responses, 3) completing a daily symptom diary following treatment, 4) being seen by the study doctor to monitor illness and recovery, and 5) completing a brief electronic questionnaire at 3 months.
- 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 18 to 60
You may be able to join if
- Active duty military, 18-60 years old
- Presence of acute watery diarrhea (3 or more loose/liquid stools in 24 hours or 2 loose/liquid stools in 24 hours and associated symptoms such as...
- Eligible for ambulatory management. (Note: Ambulatory management in this study means that the patient can be treated on an outpatient basis to...
- Able to comply with follow-up procedures.
- Will remain in country for at least 7 days or an assurance that follow-up can be arranged elsewhere.
You likely can't join if
- Allergy to rifamycins, macrolides, or loperamide (not including mild gastrointestinal upset).
- Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil...
- Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, warfarin, chloroquine and...
- Current or history of liver disease or other serious health conditions based on review by study physician.
- Acute dysentery and/or febrile illness (temperature \> 100.4°F [38.1°C]).
- Presence of symptoms \>96 hours prior to initiating treatment.
See the full eligibility criteria
- Active duty military, 18-60 years old
- Presence of acute watery diarrhea (3 or more loose/liquid stools in 24 hours or 2 loose/liquid stools in 24 hours and associated symptoms such as nausea, vomiting, abdominal cramps or tenesmus) lasting \<96 hours in...
- Eligible for ambulatory management. (Note: Ambulatory management in this study means that the patient can be treated on an outpatient basis to include up to 23 hours of medical observation and IV therapies.)
- Able to comply with follow-up procedures.
- Will remain in country for at least 7 days or an assurance that follow-up can be arranged elsewhere.
- Allergy to rifamycins, macrolides, or loperamide (not including mild gastrointestinal upset).
- Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil, tafenoquine, or doxycycline).
- Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, warfarin, chloroquine and hydroxychloroquine).
- Current or history of liver disease or other serious health conditions based on review by study physician.
- Acute dysentery and/or febrile illness (temperature \> 100.4°F [38.1°C]).
- Presence of symptoms \>96 hours prior to initiating treatment.
- Use of \>4 mg loperamide or use of any amount of loperamide for greater than 24 hours prior to enrollment. Prior use of bismuth subsalicylate or other anti-diarrheal, non-antibiotic therapy in the 48 hours prior to...
- Positive pregnancy test at presentation (unknown effects with rifaximin). All female participants will be administered a urine pregnancy test prior to enrollment.
- Previously screened or assigned by chance in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Djibouti, Djibouti
- Comayagua, Honduras
- Nanyuki, Kenya
- Santa Rosa, Nueva Ecija, Philippines
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, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Djibouti, Djibouti; Comayagua, Honduras; Nanyuki, Kenya; Santa Rosa, Nueva Ecija, Philippines. 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.