Single Dose Antibiotic Treatment of Acute Watery Diarrhea, Rifaximin Versus Azithromycin, With Loperamide Adjunct
Diarrhoea;Acute · Diarrhea Travelers
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- Fase 4
- Rango de edad
- 18 años - 60 años
- Sexo admitido
- Todos los sexos
- Voluntarios sanos
- No aceptados
- Participantes
- 128 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
Participants will be randomly assigned to one of the two treatment groups. The two groups are 1) rifaximin 550 mg as a single dose with loperamide or 2) azithromycin 500 mg as a single dose with loperamide. Both groups will take the antibiotic dose with 4 mg of loperamide. Participants are provided additional loperamide with instructions that they may take a 2 mg after continued diarrheal stools up to a maximum of 8 mg per day as needed.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
1. Active duty military, 18-60 years old
2. 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 duration that impacts function in activities and/or performance of primary duties. Refer to recruitment decision tree below.
3. 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.)
4. Able to comply with follow-up procedures.
5. Will remain in country for at least 7 days or an assurance that follow-up can be arranged elsewhere.
Exclusion Criteria:
1. Allergy to rifamycins, macrolides, or loperamide (not including mild gastrointestinal upset).
2. Antibiotic therapy in the 72 hours prior to presentation (excluding malaria prophylaxis with mefloquine, malarone, chloroquine/proguanil, tafenoquine, or doxycycline).
3. Concomitant medications with known drug-drug interactions with any of the study drugs (includes theophylline, digoxin, warfarin, chloroquine and hydroxychloroquine).
4. Current or history of liver disease or other serious health conditions based on review by study physician.
5. Acute dysentery and/or febrile illness (temperature \> 100.4°F \[38.1°C\]).
6. Presence of symptoms \>96 hours prior to initiating treatment.
7. 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 enrollment.
8. Positive pregnancy test at presentation (unknown effects with rifaximin). All female participants will be administered a urine pregnancy test prior to enrollment.
9. Previously screened or randomized in this study.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Asignación al azar
- Enmascaramiento
- Enmascaramiento cuádruple
Rifaximin with loperamide
No informado en este registro.
Drug: Rifaximin 550 MG · Drug: Loperamide
Azithromycin mg with loperamide
No informado en este registro.
Drug: Azithromycin 500 MG · Drug: Loperamide
Rifaximin 550 MG DRUG
Rifaximin 550 mg as a single dose administered orally.
Azithromycin 500 MG DRUG
Azithromycin 500 mg as a single dose administered orally.
Loperamide DRUG
4 mg loperamide administered orally with study antibiotic (rifaximin or azithromycin). Additional loperamide to use as needed, but not to exceed 16 mg/day for 2 days as per licensed use (one 2 mg capsule after each looses stool).
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Therapeutic Efficacy: Time to Last Unformed Stool (TLUS)
Plazo: Up to 1 week (up to 168 hours)
The primary efficacy endpoint is the time to last unformed stool (TLUS). TLUS is calculated from the time of antibiotic dose to last unformed stool meeting the pre-defined traveler's diarrhea definition.
Medidas secundarias
Clinical Cure Rate
Plazo: 24, 48, and 72 hours
The clinical efficacy cure rate is the percentage of participants that met criteria for both diarrhea resolution and symptom resolution within the specified window, at 24, 48, and 72 hours following initial study treatment. To meet criteria for symptom resolution, there must be no traveler's diarrhea (TD) associated symptoms reported as moderate or greater and no impact on activities for last 24 hour period.
Return to Normal Activities
Plazo: 24, 48, and 72 hours
The percentage of participants that reported activities were not impacted at the end of the specified window, at 24, 48, and 72 hours following initial study treatment.
Number of Participants With Recurrence of Traveler's Diarrhea
Plazo: 7 days
Participants that experienced a recurrence of traveler's diarrhea after previously meeting criteria for clinical cure resolution.
Number of Participants Requiring Rescue Treatment
Plazo: 3 days
The number of participants whose illness worsened or continued to impact functional capacity at the 72-hour time point requiring their treatment code to be broken so appropriate rescue treatment could be prescribed.
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (4)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
4 centros
Camp Lemonnier DjiboutiDjibouti, DjiboutiEstado desconocido
JTF-Bravo, Soto Cano ABComayagua, HondurasEstado desconocido
British Army Training Site UKNanyuki, KenyaEstado desconocido
Fort Magsaysay & Camp AguinaldoSanta Rosa, Nueva Ecija, PhilippinesEstado desconocido
Equipo y fechas
- Patrocinador principal
- Henry M. Jackson Foundation for the Advancement of Military Medicine
- Inicio del estudio
- 28 oct 2022 Real
- Finalización primaria
- 29 jun 2025 Real
- Finalización del estudio
- 2026-12 Estimado
- Primera publicación
- 10 ene 2023 Real
- Última actualización
- 10 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
A Randomized Controlled Trial Evaluating Single-dose Rifaximin Versus Azithromycin With Loperamide Adjunct for Treatment of Acute Watery Diarrhea
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 10 nov 2026