A Phase 1/2 interventional study of Methylene Blue Only and Chlorhexidine Gluconate Only in Healthcare Associated Infection, Nosocomial Infection and Surgical Site Infection, sponsored by Ondine Biomedical Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-04.
Sponsored by Ondine Biomedical Inc. · Phase 1/2, Interventional, and Basic science
The goal of this clinical trial is to evaluate the potential effects of photobiomodulation when used with topical disinfectants in the anterior nares of healthy adults.
Over a three week period, participants will have their anterior nares swabbed with methylene blue, chlorhexidine gluconate, or a combination of the two followed by 4 minutes of non-thermal red light treatment. The fourth week of consist of only red light treatment. Culture samples of the subjects nasal microbiome will be taken prior to treatment, immediately after treatment, 4-, 8-, 24-, and 48 hours after treatment.
This is an exploratory, single-center, open-label, single-arm study with microbiological endpoint using photobiomodulation (PBM) and topical disinfectants to determine the effect on the nasal microbiota.
The photobiomodulation system distributes about 700mW of light to each nostril using a 2-channel diode laser with non-thermal, red light. The topical disinfectants are methylene blue (0.01%) and chlorhexidine gluconate (0.25%). Following a pretreatment nasal culture, these two disinfectants will be administered into the patient's anterior nares followed by a two-minute light cycle. This process is repeated once more resulting in two treatments cycles (4-minutes total). Following this, nasal cultures are taken immediately and at 4-, 8-, 24-, and 48- hours. Broad spectrum and Staphylococcus spp. culturing of nasal swabs will be conducted. Swabs will also be submitted for Next Generation Sequencing to characterize the effect of light and disinfectants on the nasal microbiome.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 28 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Ondine Biomedical Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Exclusion Criteria:
All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.01% methylene blue solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.
Device: Methylene Blue Only
All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.25% chlorhexidine solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.
Device: Chlorhexidine Gluconate Only
All subjects will have an initial baseline culture done of their nasal microbiome followed by an administration of 0.01% methylene blue and 0.25% chlorhexidine gluconate solution. Next, subjects will undergo two minute of non-thermal red light exposure. A second round of solution administration and light exposure will be repeated resulting in 4 minutes of red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.
Device: Methylene Blue + Chlorhexidine Gluconate
All subjects will have an initial baseline culture done of their nasal microbiome followed by 4 minutes of non-thermal red light exposure. Once the treatment has been completed, a new culture will be taken from the subjects nares followed by one at 4-, 8-, 24-, and 48-hours after treatment.
Device: Light Only
All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: - Methylene Blue (0.01%) + 4 minutes of light treatment
All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: - Chlorhexidine gluconate (0.25%) + 4 minutes of light treatment
All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: - Methylene blue (0.01%) + chlorhexidine gluconate (0.25%) + 4 minutes of light treatment
All subjects will have a baseline sample taken of their nasal microbiome and undergo the administration of the following: - 4 minutes of light treatment only
Effect of PBM with Topical Disinfectants (Quantitative)
The Quantitative outcome measure is the change from baseline in nasal bacterial bioburden (measured in CFU/mL) by the effects of red light photobiomodulation on nasal bacteria when used with and without topical disinfectants. Each subject's baseline nasal bacterial level is determined prior to the weekly intervention. There are no subject reported outcome measures.
Time frame: The change in bacterial bioburden during the week of each of the four weeks respective intervention.
Effect of PBM with Topical Disinfectants (Semi-Quantitative)
The Semi-quantitative outcome measure is the change in bacterial growth between different time points measured by the number of quadrants with bacterial growth on a culture plate. Photographs of each culture plate will allow visual comparisons between time points. Each subject's baseline nasal bacterial level is determined prior to the weekly intervention.
Time frame: The change in bacterial bioburden during the week of each of the four weeks respective intervention.
Effect of PBM with Topical Disinfectants (NGS)
Nasal culture responses over several days will be evaluated using Next Generation Sequencing (NGS) to determine how long it takes for the nasal microbiome to return to its previous non-treated level. NGS allows for determining what percentage of the total microbiome a certain species of bacteria is.
Time frame: The change in bacterial bioburden during the week of each of the four weeks respective intervention.
Plan to share: No
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This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Ondine Biomedical Inc.