Travelers' DiarrheaPhase 4Rifaximin 600NCT00875875
Single Daily Dose Rifaximin for the Treatment of Travelers' Diarrhea
A Phase 4 study testing Rifaximin in people with Travelers' Diarrhea, run by The University of Texas Health Science Center, Houston at 1 site in Mexico.
Trial summary
The study will compare durations of diarrhea among subjects who report to clinic for treatment and who receive either: 1. standard rifaximin therapy at a dose of 200 mg three times a day for 3 days, OR 2. a single 600 mg dose of rifaximin daily for 3 days. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Travelers' Diarrhea
- What is being tested?
- Rifaximin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteMexico
- Study dates
- Jun 2009to Jun 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea
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.
- Conditions
- Travelers' Diarrhea
- Being tested
- Rifaximin
- Keywords
- Diarrhea, travelers, Acute travelers' diarrhea
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RifaximinDrug
Also called Xifaxin
Rifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | This is the approved treatment regimen for travelers' diarrhea (600 mg) Receives: Drug: Rifaximin |
| 2 | Active comparator | This is the same dose as the standard dose, given once daily (200 mg) Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time from beginning therapy to passage of last unformed stool
Measured: 5 days
Secondary outcomes (1)
Side effects as reported by the subjects on diaries
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2009
- Study completionJun 2009 (estimated)
Why it stopped: No study population in Mexico (H1N1). Study withdrawn from IRB consideration.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Travelers' DiarrheaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Charles D Ericsson, The University of Texas Health Science Center, Houston
- Investigators
- Charles D Ericsson, MD, Principal investigator, University of Texas Medical School at Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875875
- Sponsor's protocol ID
- Ericsson-001
- Acronym
- Rifaximin 600
- Status last verified
- Jun 2015
- First submitted
- 3 Apr 2009
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Daily Dose Rifaximin vs. Standard Thrice Daily Dosing for the 3-Day Treatment of Travelers' Diarrhea
- ClinicalTrials.gov ID
- NCT00875875
- Acronym / sponsor ID
- Rifaximin 600 / Ericsson-001
- Conditions
- Travelers' Diarrhea
- Keywords
- Diarrhea, travelers, Acute travelers' diarrhea
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No study population in Mexico (H1N1). Study withdrawn from IRB consideration.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (estimated)
- First posted
- 6 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: RifaximinThis is the approved treatment regimen for travelers' diarrhea (600 mg) |
| 2 | Active comparator | Drug: RifaximinThis is the same dose as the standard dose, given once daily (200 mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RifaximinAlso: XifaxinRifaximin 200 mg TID for 3 days OR Rifaximin 600 mg Daily for 3 days | Drug | 1, 2 |
Primary outcome
Time from beginning therapy to passage of last unformed stool
Time frame: 5 days
1 secondary outcome
Side effects as reported by the subjects on diaries
Time frame: 5 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charles D Ericsson, MD principal investigator
University of Texas Medical School at Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rifaximin in people with Travelers' Diarrhea, run by The University of Texas Health Science Center, Houston at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time from beginning therapy to passage of last unformed stool (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.