MRSA InfectionNCT00790972
The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity
A study testing Sinofresh in people with MRSA Infection, run by University of Chicago at 1 site in United States.
Trial summary
This is a study to assess the ability of SinoFresh Nasal \& Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- MRSA Infection
- What is being tested?
- Sinofresh
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jun 2013
- Phase
- Interventional
- 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
- 18 years or older
- The volunteer is able to adhere to the study requirements and study visits.
- Agrees to abstain from use of other nasal sprays for length of study.
- Diagnosis of an MRSA carrier by PCR testing
Who cannot join
- History of chronic nose bleeds.
- History of intranasal steroids in the last 2 months
- Nasal obstruction severe enough to prohibit effective delivery of a nasal spray
- Epistaxis
- Significant excoriation in the opinion of the Investigator.
- Known hypersensitivity to any ingredients
Trial locations and contacts
1 site in 1 country.
About this study
This is a study to assess the ability of SinoFresh Nasal \& Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.
- Conditions
- MRSA Infection
- Being tested
- Sinofresh, Placebo
- Keywords
- MRSA, sinofresh, nasal spray
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SinofreshDrug
two sprays in each nostril three times daily for one week
PlaceboDrug
two sprays in each nostril three times daily for one week
| Study group | Role | What they receive |
|---|---|---|
| 2 | Placebo comparator | Identical-appearing placebo Receives: Drug: Placebo |
| 1 | Active comparator | two sprays in each nostril three times daily for one week Receives: Drug: Sinofresh |
What is being measured
The primary outcome is the main question the study is designed to answer.
This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startJun 2007
- Primary completionJun 2010 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Company went out of business.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MRSA InfectionStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Irsk Anderson, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790972
- Sponsor's protocol ID
- 15419A
- Status last verified
- May 2016
- First submitted
- 13 Nov 2008
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of SinoFresh Nasal and Sinus Care Nasal Spray in Eliminating MRSA From the Nasal Cavity
- ClinicalTrials.gov ID
- NCT00790972
- Acronym / sponsor ID
- 15419A
- Conditions
- MRSA Infection
- Keywords
- MRSA, sinofresh, nasal spray
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Company went out of business.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Jun 2010 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 14 Nov 2008 (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.
This is a study to assess the ability of SinoFresh Nasal \& Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 | Placebo comparator | Drug: PlaceboIdentical-appearing placebo |
| 1 | Active comparator | Drug: Sinofreshtwo sprays in each nostril three times daily for one week |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years or older
- The volunteer is able to adhere to the study requirements and study visits.
- Agrees to abstain from use of other nasal sprays for length of study.
- Diagnosis of an MRSA carrier by PCR testing
Key exclusion criteria (6 listed)
- History of chronic nose bleeds.
- History of intranasal steroids in the last 2 months
- Nasal obstruction severe enough to prohibit effective delivery of a nasal spray
- Epistaxis
- Significant excoriation in the opinion of the Investigator.
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 |
|---|---|---|
| Sinofreshtwo sprays in each nostril three times daily for one week | Drug | 1 |
| Placebotwo sprays in each nostril three times daily for one week | Drug | 2 |
Primary outcome
This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose.
Time frame: 7 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 20 May 2016.
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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.
Irsk Anderson, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinofresh in people with MRSA Infection, run by University of Chicago at 1 site in United States.
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 4 inclusion and 6 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 20 May 2016. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
This is a study to assess the ability of SinoFresh Nasal & Sinus Care, an FDA approved over-the-counter nasal spray, to eliminate the bacteria in your nose. (time frame: 7 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 20 May 2016.