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| Name | Class |
|---|---|
| Thrasher Research Fund | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days. |
|
| Placebo | Placebo Comparator | Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chlorhexidine gluconate | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. . | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 28 days |
| Number of Participants With Persistent Same Strain of S. Aureus Genetic Backgrounds at 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Loren G Miller, MD, MPH | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles BioMedical Research Institute (LA BioMed) | Torrance | California | 90502 | United States |
After publication of trial results, data will be shared with investigators upon request to the Principal Investigator and after signing a Data Use Agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.12% Chlorhexidine Gluconate Oral Rinse | Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days. Chlorhexidine gluconate: 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. |
| FG001 | Saline Placebo Oral Rinse | Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days. Saline Placebo: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0.12% Chlorhexidine Gluconate Oral Rinse | Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days. Chlorhexidine gluconate: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. . | Posted | Count of Participants | Participants | 7 days |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.12% Chlorhexidine Gluconate Oral Rinse | Randomized to 15mL 0.12% Chlorhexidine Gluconate oral rinse, to be used twice daily for 60 seconds for 7 days. Chlorhexidine gluconate: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| other | Gastrointestinal disorders | Systematic Assessment | Patient experienced vomiting |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Loren G. Miller | The Lundquist Institute at Harbor-UCLA | 310-222-3775 | lmiller@lundquist.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 30, 2015 | Jun 11, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| C010882 | chlorhexidine gluconate |
| D002710 | Chlorhexidine |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| Saline Placebo | Drug | 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. |
|
We characterized isolates associated with breakthrough of oropharyngeal colonization. Here we show the breakthrough isolates of the same strain at 28 days. |
| 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. | 28 days |
| BG001 | Saline Placebo Oral Rinse | Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days. Saline Placebo: 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days.
Saline Placebo: 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.
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 28 days |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 28 days |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 1 |
| 33 |
| EG001 | Saline Placebo Oral Rinse | Randomized to 15mL saline placebo oral rinse, to be used twice daily for 60 seconds for 7 days. Saline Placebo: 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. | 0 | 34 | 0 | 34 | 1 | 34 |
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