Single Daily Dose Rifaximin for the Treatment of Traveler... | NCT00875875

Studies
Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea

NCT00875875

Sponsor

The University of Texas Health Science Center, Houston

Status

Withdrawn

Last Update Posted

Jun 10, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Travelers' Diarrhea

Interventions

Rifaximin

Countries

Mexico

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No study population in Mexico (H1N1). Study withdrawn from IRB consideration.

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2009Actual

Completion Date

Jun 2009Estimated

First Submitted Date

Apr 3, 2009

First Submission Date that Met QC Criteria

Apr 3, 2009

First Posted Date

Apr 6, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2015

Last Update Posted Date

Jun 10, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Charles D Ericsson, ◦Professor and Dr. and Mrs. Carl V. Vartian Professor in Infectious Diseases, The University of Texas Health Science Center, HoustonPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center, HoustonOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either:

standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR
a single 600 mg dose of rifaximin daily for 3 days.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	This is the approved treatment regimen for travelers' diarrhea (600 mg)	Drug: Rifaximin
2	Active Comparator	This is the same dose as the standard dose, given once daily (200 mg)	Drug: Rifaximin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Rifaximin	Drug	Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days	1 2

Measure	Description	Time Frame
Time from beginning therapy to passage of last unformed stool		5 days

Measure	Description	Time Frame
Side effects as reported by the subjects on diaries		5 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

passage of 3 or more unformed stools in 24 hours plus an additional symptom of enteric disease such as abdominal cramps, nausea, vomiting, or fever; and investigator verification that an unformed stool has been submitted.
is > 18 years of age
has diarrhea (at least three unformed stools in 24 hrs) plus at least one additional sign or symptom of enteric illness
has acute diarrhea less than 1 week's duration
willingness to provide a diarrhea stool sample
willingness to keep a daily diary for 5 days
signed informed consent

Exclusion Criteria:

fever or bloody diarrhea
has taken predictably effective antibiotics in the past week (e.g. quinolones, TMP/SMX, azalide or doxycycline)
is pregnant now, likely to become pregnant, or breast-feeding
has duration of diarrhea of greater than 1 weeks
is allergic to Rifampin or Rifaximin
has a history of significant underlying enteric, pulmonary, cardiac, renal disease, or any CNS disorder
is more than moderately dehydrated

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charles D Ericsson, MD	University of Texas Medical School at Houston	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Enteric Disease Clinic		Guadalajara	Jalisco		Mexico

Condition Browse Module

MeSH Terms

ID	Term
D003967	Diarrhea

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000078262	Rifaximin

Ancestor Terms

ID	Term
D012294	Rifamycins
D006576	Heterocyclic Compounds, 4 or More Rings
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided