S. Aureus Oropharyngeal ColonizationPhase 2NCT02589067
Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
A Phase 2 study testing Chlorhexidine gluconate in people with S. Aureus Oropharyngeal Colonization, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial summary
The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- S. Aureus Oropharyngeal Colonization
- What is being tested?
- Chlorhexidine gluconate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Nov 2017
- Phase
- Phase 2
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- History of skin or soft tissue infection that occurred between 1 month and 5 years ago, regardless of whether antibiotics were given, as per patient report
- Age > 5 years and < 18 years.
- Able to gargle as assessed by verbal question.
- Willing and able to undergo nares and oropharyngeal swabbing.
- Able to come to the research clinic for study follow-up visits for the study period.
Who cannot join
- Current suspected or confirmed infection requiring systemic antibiotics.
- Receipt of systemic antibiotics in the prior 28 days.
- Plans for administration or likely receipt of systemic antibiotics in the next 28 days (e.g., if the patient suffers from recurrent infections such as otitis media or has a planned surgery that requires prophylactic antibiotics).
- Plans for hospitalization or likely hospitalization in the next 28 days (e.g., if the patient suffers from recurrent infections)
- Any of the following in the prior 6 months: hemodialysis, peritoneal dialysis, central venous catheter placement, and systemic chemotherapy for cancer, any immune-compromising condition.
- Previous participation in the study.
- Pregnancy (all female subjects of childbearing age will be given a pregnancy test prior to enrollment).
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles BioMedical Research Institute (LA BioMed)
Torrance, California, 90502
About this study
Official title: Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization.
The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA.
This problem will be studied through a randomized, double-blind, placebo-controlled clinical trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S. aureus in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use in children as its safety has been widely established, and it is readily commercially available. Eligible, consented subjects will be asked to participate in a baseline study visit in which swabs of their oropharynx and nares are obtained, and they are educated on the use of either CHG oral rinse or a placebo oral rinse containing saline. The subjects will be instructed to perform the oral rinse twice daily for seven days. Two follow-up visits will occur at 7 and 28 days post-baseline, where subjects' nares and oropharynx are again swabbed in order to ascertain short- and long-term decolonization of S. aureus. This procedure will serve to 1) determine the efficacy of a CHG oral rinse in decolonization of S. aureus, 2) investigate the safety, tolerability, and compliance of oropharyngeal decolonization among children and their caregivers, and 3) determine the genetic backgrounds of strains of S. aureus associated with continued colonization.
Read the detailed description
Each year, children visit doctors offices and emergency rooms over 2 million times due to skin and soft tissue infections (SSTIs). These SSTIs are usually caused by a bacteria called Staphylococcus aureus (S. aureus), and can result in severe negative consequences such as hospitalization, disability, and even death. Despite treatment with antibiotics, 20-70% of children with an SSTI will develop a recurrent infection within the next year. Additionally, this treatment fails to eradicate S. aureus from children nearly 50% of the time. Of the types of S. aureus that cause these infections, antibiotic-resistant strains such as methicillin-resistant S. aureus (MRSA), which are associated with higher rates of transmission, have become increasingly more common. Thus, the problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA.
- Conditions
- S. Aureus Oropharyngeal Colonization
- Being tested
- Chlorhexidine gluconate, Saline Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine gluconateDrug
Also called Peridex, Periogard
Oral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus.
Saline PlaceboDrug
Placebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days. Receives: Drug: Chlorhexidine gluconate |
| Placebo | Placebo comparator | Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days. Receives: Drug: Saline Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Eradiction of S. Aureus From the Oropharyngeal at 7 Days
The primary endpoint is eradication of S. aureus oropharyngeal colonization at 7 days using an intention to treat (ITT) model.
.
Measured: 7 days
Secondary outcomes (3)
Number of Participants Eradication of S. Aureus Oropharyngeal Colonization at 28 Days
Secondary outcome is eradication of S. aureus oropharyngeal colonization at 28 days using an intention to treat (ITT) model.
Measured: 28 days
Number of Participants With Persistent Same Strain of S. Aureus Genetic Backgrounds at 28 Days
We characterized isolates associated with breakthrough of oropharyngeal colonization. Here we show the breakthrough isolates of the same strain at 28 days.
Measured: 28 days
Number of Participants With Persistent Different Strain of S. Aureus Genetic Backgrounds at 28 Days
We characterized isolates associated with breakthrough of oropharyngeal colonization. Here we show the breakthrough isolates of different strains at 28 days.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2017
- Study completionNov 2017
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 S. Aureus Oropharyngeal ColonizationStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Thrasher Research Fund
- Responsible party
- Sponsor
- Investigators
- Loren G Miller, MD, MPH, Principal investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02589067
- Sponsor's protocol ID
- 30529
- Status last verified
- Jun 2020
- First submitted
- 20 Oct 2015
- Last updated
- 29 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: After publication of trial results, data will be shared with investigators upon request to the Principal Investigator and after signing a Data Use Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization.
- ClinicalTrials.gov ID
- NCT02589067
- Acronym / sponsor ID
- 30529
- Conditions
- S. Aureus Oropharyngeal Colonization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Thrasher Research Fund
- Study start
- Oct 2015 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Posted 29 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA.
This problem will be studied through a randomized, double-blind, placebo-controlled clinical trial of the use of a 0.12% clorhexidine gluconate (CHG) oral rinse in decolonizing S. aureus in the oropharynx in children 5-17 years old. CHG is an excellent candidate for use in children as its safety has been widely established, and it is readily commercially available. Eligible, consented subjects will be asked to participate in a baseline study visit in which swabs of their oropharynx and nares are obtained, and they are educated on the use of either CHG oral rinse or a placebo oral rinse containing saline. The subjects will be instructed to perform the oral rinse twice daily for seven days. Two follow-up visits will occur at 7 and 28 days post-baseline, where subjects' nares and oropharynx are again swabbed in order to ascertain short- and long-term decolonization of S. aureus. This procedure will serve to 1) determine the efficacy of a CHG oral rinse in decolonization of S. aureus, 2) investigate the safety, tolerability, and compliance of oropharyngeal decolonization among children and their caregivers, and 3) determine the genetic backgrounds of strains of S. aureus associated with continued colonization.
Detailed description
Each year, children visit doctors offices and emergency rooms over 2 million times due to skin and soft tissue infections (SSTIs). These SSTIs are usually caused by a bacteria called Staphylococcus aureus (S. aureus), and can result in severe negative consequences such as hospitalization, disability, and even death. Despite treatment with antibiotics, 20-70% of children with an SSTI will develop a recurrent infection within the next year. Additionally, this treatment fails to eradicate S. aureus from children nearly 50% of the time. Of the types of S. aureus that cause these infections, antibiotic-resistant strains such as methicillin-resistant S. aureus (MRSA), which are associated with higher rates of transmission, have become increasingly more common. Thus, the problem of interest is the high rate of recurrent SSTIs in children caused by S. aureus despite the use of systemic antibiotic treatment, due to difficulties in decolonization and the prevalence of antibiotic-resistant strains such as MRSA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Chlorhexidine gluconateRandomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days. |
| Placebo | Placebo comparator | Drug: Saline PlaceboRandomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days. |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- History of skin or soft tissue infection that occurred between 1 month and 5 years ago, regardless of whether antibiotics were given, as per patient report
- Age > 5 years and < 18 years.
- Able to gargle as assessed by verbal question.
- Willing and able to undergo nares and oropharyngeal swabbing.
- Able to come to the research clinic for study follow-up visits for the study period.
Key exclusion criteria (7 listed)
- Current suspected or confirmed infection requiring systemic antibiotics.
- Receipt of systemic antibiotics in the prior 28 days.
- Plans for administration or likely receipt of systemic antibiotics in the next 28 days (e.g., if the patient suffers from recurrent infections such as otitis media or has a planned surgery that requires prophylactic antibiotics).
- Plans for hospitalization or likely hospitalization in the next 28 days (e.g., if the patient suffers from recurrent infections)
- Any of the following in the prior 6 months: hemodialysis, peritoneal dialysis, central venous catheter placement, and systemic chemotherapy for cancer, any immune-compromising condition.
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 |
|---|---|---|
| Chlorhexidine gluconateAlso: Peridex, PeriogardOral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus. | Drug | Experimental |
| Saline PlaceboPlacebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus. | Drug | Placebo |
Primary outcome
Number of Participants With Eradiction of S. Aureus From the Oropharyngeal at 7 Days
Time frame: 7 days
The primary endpoint is eradication of S. aureus oropharyngeal colonization at 7 days using an intention to treat (ITT) model. .
3 secondary outcomes
Number of Participants Eradication of S. Aureus Oropharyngeal Colonization at 28 Days
Time frame: 28 days
Number of Participants With Persistent Same Strain of S. Aureus Genetic Backgrounds at 28 Days
Time frame: 28 days
Number of Participants With Persistent Different Strain of S. Aureus Genetic Backgrounds at 28 Days
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. After publication of trial results, data will be shared with investigators upon request to the Principal Investigator and after signing a Data Use Agreement.
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.
Loren G Miller, MD, MPH principal investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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 Chlorhexidine gluconate in people with S. Aureus Oropharyngeal Colonization, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center 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 5 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 29 Dec 2020. 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.
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?
Yes. Results are posted in the registry (first posted 29 Dec 2020). 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?
Number of Participants With Eradiction of S. Aureus From the Oropharyngeal at 7 Days (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 29 Dec 2020.