Trial Outcomes & Findings for Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization (NCT NCT02589067)
NCT ID: NCT02589067
Last Updated: 2020-12-29
Results Overview
The primary endpoint is eradication of S. aureus oropharyngeal colonization at 7 days using an intention to treat (ITT) model. .
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
67 participants
Primary outcome timeframe
7 days
Results posted on
2020-12-29
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
34
|
|
Overall Study
COMPLETED
|
28
|
28
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Decolonization of the Oropharynx, an Important and Neglected Reservoir of S. Aureus Colonization
Baseline characteristics by cohort
| Measure |
0.12% Chlorhexidine Gluconate Oral Rinse
n=33 Participants
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.
|
Saline Placebo Oral Rinse
n=34 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.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
33 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
11 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
12.4 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
11 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Hispanic
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Not Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
34 participants
n=7 Participants
|
67 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 7 daysThe primary endpoint is eradication of S. aureus oropharyngeal colonization at 7 days using an intention to treat (ITT) model. .
Outcome measures
| Measure |
0.12% Chlorhexidine Gluconate Oral Rinse
n=33 Participants
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.
|
Saline Placebo Oral Rinse
n=34 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.
|
|---|---|---|
|
Number of Participants With Eradiction of S. Aureus From the Oropharyngeal at 7 Days
|
18 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 28 daysSecondary outcome is eradication of S. aureus oropharyngeal colonization at 28 days using an intention to treat (ITT) model.
Outcome measures
| Measure |
0.12% Chlorhexidine Gluconate Oral Rinse
n=33 Participants
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.
|
Saline Placebo Oral Rinse
n=34 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.
|
|---|---|---|
|
Number of Participants Eradication of S. Aureus Oropharyngeal Colonization at 28 Days
|
13 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 28 daysWe characterized isolates associated with breakthrough of oropharyngeal colonization. Here we show the breakthrough isolates of the same strain at 28 days.
Outcome measures
| Measure |
0.12% Chlorhexidine Gluconate Oral Rinse
n=33 Participants
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.
|
Saline Placebo Oral Rinse
n=34 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.
|
|---|---|---|
|
Number of Participants With Persistent Same Strain of S. Aureus Genetic Backgrounds at 28 Days
|
4 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: 28 daysWe characterized isolates associated with breakthrough of oropharyngeal colonization. Here we show the breakthrough isolates of different strains at 28 days.
Outcome measures
| Measure |
0.12% Chlorhexidine Gluconate Oral Rinse
n=33 Participants
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.
|
Saline Placebo Oral Rinse
n=34 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.
|
|---|---|---|
|
Number of Participants With Persistent Different Strain of S. Aureus Genetic Backgrounds at 28 Days
|
4 Participants
|
7 Participants
|
Adverse Events
0.12% Chlorhexidine Gluconate Oral Rinse
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Saline Placebo Oral Rinse
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
0.12% Chlorhexidine Gluconate Oral Rinse
n=33 participants at risk
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.
|
Saline Placebo Oral Rinse
n=34 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
other
|
3.0%
1/33 • Number of events 1 • 2 years
|
2.9%
1/34 • Number of events 1 • 2 years
|
Additional Information
Dr. Loren G. Miller
The Lundquist Institute at Harbor-UCLA
Phone: 310-222-3775
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place