PropionibacteriumNCT02688738
Does Preoperative Administration of Oral Doxycycline Decrease the Colonization Rate of Propionibacterium Acnes in the Dermis of the Shoulder?
A study testing Doxycycline in people with Propionibacterium, run by Rothman Institute Orthopaedics.
Trial summary
The purpose of this study is to evaluate the ability of oral doxycycline to decrease the colonization of Propionibacterium acnes in the dermis of the shoulder. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Propionibacterium
- What is being tested?
- Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Mar 2015to Dec 2016
- 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 Any age
- Child, Adult, Older adult
Who may be able to join
- -All male patients (>18 years of age) undergoing shoulder arthroscopy
Who cannot join
- Female patients
- patients with active acne
- patients who have taken antibiotics in the past month
- doxycycline allergy
- benzoyl peroxide allergy
- clindamycin allergy
- patients with psoriatic/eczematous or other lesions on the shoulder girdle.
About this study
The purpose of this study is to evaluate the ability of oral doxycycline to decrease the colonization of Propionibacterium acnes in the dermis of the shoulder.
- Conditions
- Propionibacterium
- Being tested
- Doxycycline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxycyclineDrug
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard of care |
| Treatment | Active comparator | Oral doxycycline Receives: Drug: Doxycycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of P acnes grown from anaerobic or aerobic culture
Measured: within 14 days of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startMar 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PropionibacteriumStudies 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 N/A
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688738
- Sponsor's protocol ID
- 2016SNam
- Status last verified
- Feb 2016
- First submitted
- 11 Feb 2016
- Last updated
- 23 Feb 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preoperative Administration of Oral Doxycycline Decrease the Colonization Rate of Propionibacterium Acnes in the Dermis of the Shoulder?
- ClinicalTrials.gov ID
- NCT02688738
- Acronym / sponsor ID
- 2016SNam
- Conditions
- Propionibacterium
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 23 Feb 2016 (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 purpose of this study is to evaluate the ability of oral doxycycline to decrease the colonization of Propionibacterium acnes in the dermis of the shoulder.
Study design
- Primary purpose
- Prevention
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard of care |
| Treatment | Active comparator | Drug: DoxycyclineOral doxycycline |
Who may qualify
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- -All male patients (>18 years of age) undergoing shoulder arthroscopy
Key exclusion criteria (7 listed)
- Female patients
- patients with active acne
- patients who have taken antibiotics in the past month
- doxycycline allergy
- benzoyl peroxide allergy
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 |
|---|---|---|
| Doxycycline | Drug | Treatment |
Primary outcome
Quantification of P acnes grown from anaerobic or aerobic culture
Time frame: within 14 days of surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
Related trials for Propionibacterium
Recruiting
Antimicrobial Prophylaxis for Skin Colonization With Propionibacterium Acnes in Primary Open Shoulder Surgery
Propionibacterium Infection
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Doxycycline in people with Propionibacterium, run by Rothman Institute Orthopaedics.
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 1 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: status not confirmed, as of the sponsor's last update on 23 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
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?
Quantification of P acnes grown from anaerobic or aerobic culture (time frame: within 14 days of surgery). 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 23 Feb 2016.