Community-acquired Methicillin-resistant Staphylococcus Aureus InfectionPhase 2NCT01748318
New Mexico Honey Wound Treatment Research Study
A Phase 2 study testing New Mexico Honey and Bactrim DS in people with Community-acquired Methicillin-resistant Staphylococcus Aureus Infection, run by R. Stephen Rankin, M.D. at 1 site in United States.
Trial summary
In a time of emerging bacteria that are resistant to antibiotics, honey offers an alternative that has potential to reduce the heavy reliance on pharmaceutical antibiotics. We will be evaluating the effectiveness of a locally produced New Mexico Honey against the standard of care Bactrim antibiotic on Community… Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Community-acquired Methicillin-resistant Staphylococcus Aureus Infection
- What is being tested?
- New Mexico Honey and Bactrim DS
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Jul 2018
- Phase
- Phase 2
- 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 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients 16 years of age or older
- Abscess less than or equal to 6 cm in diameter on the extremity or trunk requiring incision and drainage
- Patient willing to try honey prepared dressing
- Patient able to return to office each day for 7 days for evaluation
Who cannot join
- Under the age of 16
- Abscess of face, scalp or genitals
- Diagnosed as a diabetic
- Allergic to bee pollen, honey or sulfa antibiotics
- Diagnosed with peripheral vascular disease
- Patient acknowledgement of current drug or alcohol abuse
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Pinon Family Practice
Farmington, New Mexico, 87401
R Stephen Rankin, MD, 505-324-1000
R Stephen Rankin, MD
About this study
In a time of emerging bacteria that are resistant to antibiotics, honey offers an alternative that has potential to reduce the heavy reliance on pharmaceutical antibiotics. We will be evaluating the effectiveness of a locally produced New Mexico Honey against the standard of care Bactrim antibiotic on Community Acquired MRSA.
Read the detailed description
Locally grown New Mexico Honey will be utilized on abscess wounds of the trunk and extremities vs routine (Bactrim) antibiotic care to determine if NM Honey is effective treatment for Community Acquired MRSA 6 cm abscesses.
- Being tested
- New Mexico Honey, Bactrim DS
- Keywords
- Community acquired MRSA, New Mexico Honey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Mexico HoneyDrug
Also called Local New Mexico Honey
Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment
Bactrim DSDrug
Also called sulfamethoxazle-trimethroprim DS
Bactrim DS
| Study group | Role | What they receive |
|---|---|---|
| NM Regional Honey | Experimental | 15 ml of NM Honey applied directly to wound Receives: Drug: New Mexico Honey; Drug: Bactrim DS |
| Bactrim DS | Active comparator | Standard of Care Oral Antibiotic Receives: Drug: New Mexico Honey; Drug: Bactrim DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Size of lesion at day 7
Increase in size will determine failure; Decrease in size will determine success
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 posted12 Dec 2012 (estimated)
- Study startMar 2013
- Primary completionMay 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Community-acquired Methicillin-resistant Staphylococcus Aureus InfectionStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- R. Stephen Rankin, M.D.
- Responsible party
- Sponsor-investigator, R. Stephen Rankin, M.D., Rankin, R. Stephen, M.D.
- Investigators
- R Stephen Rankin, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748318
- Sponsor's protocol ID
- IND 115653
- Status last verified
- May 2016
- First submitted
- 10 Dec 2012
- Last updated
- 10 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Mexico Honey Wound Treatment Research Study
- ClinicalTrials.gov ID
- NCT01748318
- Acronym / sponsor ID
- IND 115653
- Keywords
- Community acquired MRSA, New Mexico Honey
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- R. Stephen Rankin, M.D.
- Study start
- Mar 2013
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 12 Dec 2012 (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.
In a time of emerging bacteria that are resistant to antibiotics, honey offers an alternative that has potential to reduce the heavy reliance on pharmaceutical antibiotics. We will be evaluating the effectiveness of a locally produced New Mexico Honey against the standard of care Bactrim antibiotic on Community Acquired MRSA.
Detailed description
Locally grown New Mexico Honey will be utilized on abscess wounds of the trunk and extremities vs routine (Bactrim) antibiotic care to determine if NM Honey is effective treatment for Community Acquired MRSA 6 cm abscesses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NM Regional Honey | Experimental | Drug: New Mexico Honey, Drug: Bactrim DS15 ml of NM Honey applied directly to wound |
| Bactrim DS | Active comparator | Drug: New Mexico Honey, Drug: Bactrim DSStandard of Care Oral Antibiotic |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients 16 years of age or older
- Abscess less than or equal to 6 cm in diameter on the extremity or trunk requiring incision and drainage
- Patient willing to try honey prepared dressing
- Patient able to return to office each day for 7 days for evaluation
Key exclusion criteria (6 listed)
- Under the age of 16
- Abscess of face, scalp or genitals
- Diagnosed as a diabetic
- Allergic to bee pollen, honey or sulfa antibiotics
- Diagnosed with peripheral vascular disease
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 |
|---|---|---|
| New Mexico HoneyAlso: Local New Mexico HoneyApply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment | Drug | Bactrim DS, NM Regional Honey |
| Bactrim DSAlso: sulfamethoxazle-trimethroprim DSBactrim DS | Drug | Bactrim DS, NM Regional Honey |
Primary outcome
Size of lesion at day 7
Time frame: 7 days
Increase in size will determine failure; Decrease in size will determine success
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2016.
- Individual participant dataSharing planned: Yes
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.
R Stephen Rankin, MD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing New Mexico Honey and Bactrim DS in people with Community-acquired Methicillin-resistant Staphylococcus Aureus Infection, run by R. Stephen Rankin, M.D. 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: status not confirmed, as of the sponsor's last update on 10 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact R Stephen Rankin, MD (505 324 1000, rstephen_rankin@msn.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Size of lesion at day 7 (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 10 May 2016.