Traveler's DiarrheaPhase 3ERASENCT01208922
Rifamycin SV-MMX® Tablets Versus Ciprofloxacin Capsules in Acute Traveller's Diarrhoea
A Phase 3 study testing Rifamycin SV-MMX® and Ciprofloxacin in people with Traveler's Diarrhea, run by Dr. Falk Pharma GmbH at 19 sites in 3 countries.
Trial summary
The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Traveler's Diarrhea
- What is being tested?
- Rifamycin SV-MMX® and Ciprofloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 835 participants
- Where
- 19 sitesin 3 countries
- Study dates
- Nov 2010to May 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent,
- Men or women between 18 and 85 years of age,
- History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks,
- Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours),
- Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency),
- Women of childbearing potential had to apply during the entire duration of the study a highly effective method of birth control
Who cannot join
- Residency in any country with high incidence rate of TD within the past 6 months,
- Fever (defined as a body (oral) temperature >100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment),
- Known or suspected infection with non-bacterial pathogen,
- Presence of diarrhoea of >72 hours duration,
- Presence of grossly bloody stool,
- Presence of moderate or severe dehydration (i.e. symptoms of hypovolemia such as orthostatic hypotension, dizziness or wrinkling of skin),
- History of inflammatory bowel disease or celiac disease,
Trial locations and contacts
19 sites in 3 countries.
19 sites in 3 countries
India17 sites
Site 124
Ajmer
Site 118
Bardez
Site 120
Calangute
Site 104
Hyderabad
Site 114
Kolkata
Site 116
Lucknow
Site 107
Madgaon
Site 110
Madgaon
Site 101
Mapusa, Karaswada
Site 123
New Delhi
Site 122
Panjim
Site 102
Puducherry
Site 115
Pushkar
Site 119
Salcette
Site 111
Tiswadi
Site 109
Varanasi
Site 103
Vijayawada
About this study
Official title: A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy and Safety of Oral Daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the Treatment of Acute Infectious Diarrhoea in Travellers
The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
- Conditions
- Traveler's Diarrhea
- Being tested
- Rifamycin SV-MMX®, Ciprofloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifamycin SV-MMX®Drug
2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
CiprofloxacinDrug
1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Rifamycin SV-MMX® 200 mg tablets Receives: Drug: Rifamycin SV-MMX® |
| Group B | Active comparator | Ciprofloxacin 500 mg capsules Receives: Drug: Ciprofloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Last Unformed Stool (TLUS)
Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.
Measured: 5 days
Secondary outcomes (1)
Number of Patients With Clinical Cure
Clinical Cure Rate: 24-hour period with no clinical symptoms except mild flatulence, no fever, no watery stools and no more than 2 soft stools OR 48-hour period with no stools or only formed stools, and no fever, with our without symptoms of enteric infection.
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 posted24 Sep 2010 (estimated)
- Study startNov 2010
- Primary completionJan 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Traveler's DiarrheaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 835 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Falk Pharma GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Professor Robert Steffen, M. D., Principal investigator, University of Zurich, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01208922
- Sponsor's protocol ID
- RIT-1/AID
- Acronym
- ERASE
- Status last verified
- Oct 2018
- First submitted
- 23 Sep 2010
- Last updated
- 27 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Double-dummy, Multi-centre, Comparative Parallel-group Study to Evaluate the Efficacy and Safety of Oral Daily Rifamycin SV-MMX® 400 mg b.i.d. vs. Ciprofloxacin 500 mg b.i.d. in the Treatment of Acute Infectious Diarrhoea in Travellers
- ClinicalTrials.gov ID
- NCT01208922
- Acronym / sponsor ID
- ERASE / RIT-1/AID
- Conditions
- Traveler's Diarrhea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 835 participants (actual)
- Lead sponsor
- Dr. Falk Pharma GmbHIndustry (pharma, biotech, devices)
- Study start
- Nov 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 24 Sep 2010 (estimated)
- Results
- Posted 27 Feb 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to prove the non-inferiority of Rifamycin SV-MMX® versus Ciprofloxacin for the treatment of adults with traveller's diarrhoea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Rifamycin SV-MMX®Rifamycin SV-MMX® 200 mg tablets |
| Group B | Active comparator | Drug: CiprofloxacinCiprofloxacin 500 mg capsules |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent,
- Men or women between 18 and 85 years of age,
- History of arriving from their country of residence in the industrialized part of the world within the past 4 weeks,
- Presenting with acute infectious diarrhoea (defined as at least 3 unformed, watery or soft stools accompanied by symptoms within 24 hours preceding randomisation with duration of illness ≤ 72 hours),
- Presence of one or more signs or symptoms of enteric infection (moderate to severe gas/flatulence, nausea, vomiting, abdominal cramps or pain, rectal tenesmus, fecal urgency),
Key exclusion criteria (7 listed)
- Residency in any country with high incidence rate of TD within the past 6 months,
- Fever (defined as a body (oral) temperature >100.4°F or 38.0°C; antipyretic medication should not have been administered in the 6 hours prior to this assessment),
- Known or suspected infection with non-bacterial pathogen,
- Presence of diarrhoea of >72 hours duration,
- Presence of grossly bloody stool,
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 |
|---|---|---|
| Rifamycin SV-MMX®2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d. | Drug | Group A |
| Ciprofloxacin1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d. | Drug | Group B |
Primary outcome
Time to Last Unformed Stool (TLUS)
Time frame: 5 days
Time to Last Unformed Stool (TLUS), defined as the interval in hours between the first dose of study drug and the last unformed stool passed, after which clinical cure was declared.
1 secondary outcome
Number of Patients With Clinical Cure
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Professor Robert Steffen, M. D. principal investigator
University of Zurich, Switzerland
19 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rifamycin SV-MMX® and Ciprofloxacin in people with Traveler's Diarrhea, run by Dr. Falk Pharma GmbH at 19 sites in 3 countries.
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 6 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: finished, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in India, Ecuador, Guatemala. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 to Last Unformed Stool (TLUS) (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 27 Feb 2019.