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| Name | Class |
|---|---|
| University of Houston | OTHER |
| High Point University | OTHER |
| Paratek Pharmaceuticals Inc | INDUSTRY |
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Given the clinical need to improve upon current antibiotic regimens for the treatment of C. difficile infection with a particular focus on the impact of therapies on gut microbiome, this study proposes to characterize the impact of Intravenous (IV) omadacycline on gut microbiome of healthy volunteers.
The plan to enroll eight healthy volunteers between the ages of 18 and 40 years and without history of cardiovascular, gastrointestinal, hepatic, or renal disease to receive 5 days of intravenous omadacycline followed by 5 days of oral omadacycline. Stool and saliva samples will be collected at pre-specified times and analyzed to characterize the impact of IV omadacycline on gut microbiome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous (IV) Omadacycline | Experimental | All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Omadacycline Injection | Drug | All participants will receive Intravenous (IV) omadacycline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phylum Level Mean Proportional Relative Abundance | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Day 30 |
| Phylum Level Mean Proportional Relative Abundance | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Baseline |
| Phylum Level Mean Proportional Relative Abundance | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Day 5 |
| Phylum Level Mean Proportional Relative Abundance | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Day 10 |
| Bacterial DNA Per Gram of Stool | nanograms (ng) per gram of stool for bacterial DNA | Baseline |
| Bacterial DNA Per Gram of Stool | nanograms (ng) per gram of stool for bacterial DNA | During Therapy up to Day 6 |
| Bacterial DNA Per Gram of Stool | nanograms (ng) per gram of stool for bacterial DNA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John C Williamson, PharmD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
IPD that underlie the results reported in this article, after deidentification
Beginning 6 months following article publication and ending 36 months following article publication
Researchers who provide a methodologically sound proposal
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous (IV) Omadacycline | All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline Omadacycline Injection: All participants will receive Intravenous (IV) omadacycline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous (IV) Omadacycline | All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline Omadacycline Injection: All participants will receive Intravenous (IV) omadacycline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Phylum Level Mean Proportional Relative Abundance | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Posted | Mean | Standard Deviation | % gram positive (+) for phylum | Day 30 |
|
|
31 days
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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 | Intravenous (IV) Omadacycline | All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline Omadacycline Injection: All participants will receive Intravenous (IV) omadacycline |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Williamson, PharmD | Wake Forest University Health Sciences | 336.713.3431 | johnwill@wakehealth.edu |
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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 | Apr 24, 2023 | Nov 27, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 8, 2023 | Nov 27, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003141 | Communicable Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000591640 | omadacycline |
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| End of Therapy up to Day 10 |
| Order Level Mean Proportional Relative Abundance | Order Level Mean Proportional Relative Abundance - Relative abundance % for order | Baseline |
| Order Level Mean Proportional Relative Abundance | Order Level Mean Proportional Relative Abundance - Relative abundance % for order | Day 5 |
| Order Level Mean Proportional Relative Abundance | Order Level Mean Proportional Relative Abundance - Relative abundance % for order | Day 10 |
| Order Level Mean Proportional Relative Abundance | Order Level Mean Proportional Relative Abundance - Relative abundance % for order | Day 30 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | Phylum Level Mean Proportional Relative Abundance | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Posted | Mean | Standard Deviation | % gram positive (+) for phylum | Baseline |
|
|
|
| Primary | Phylum Level Mean Proportional Relative Abundance | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Posted | Mean | Standard Deviation | % gram positive (+) for phylum | Day 5 |
|
|
|
| Primary | Phylum Level Mean Proportional Relative Abundance | In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity. | Posted | Mean | Standard Deviation | % gram positive (+) for phylum | Day 10 |
|
|
|
| Primary | Bacterial DNA Per Gram of Stool | nanograms (ng) per gram of stool for bacterial DNA | Posted | Mean | Standard Deviation | 10^7 ng/g | Baseline |
|
|
|
| Primary | Bacterial DNA Per Gram of Stool | nanograms (ng) per gram of stool for bacterial DNA | Posted | Mean | Standard Deviation | 10^7 ng/g | During Therapy up to Day 6 |
|
|
|
| Primary | Bacterial DNA Per Gram of Stool | nanograms (ng) per gram of stool for bacterial DNA | Posted | Mean | Standard Deviation | 10^7 ng/g | End of Therapy up to Day 10 |
|
|
|
| Primary | Order Level Mean Proportional Relative Abundance | Order Level Mean Proportional Relative Abundance - Relative abundance % for order | Posted | Mean | Standard Deviation | Relative abundance % for order | Baseline |
|
|
|
| Primary | Order Level Mean Proportional Relative Abundance | Order Level Mean Proportional Relative Abundance - Relative abundance % for order | Posted | Mean | Standard Deviation | Relative abundance % for order | Day 5 |
|
|
|
| Primary | Order Level Mean Proportional Relative Abundance | Order Level Mean Proportional Relative Abundance - Relative abundance % for order | Posted | Mean | Standard Deviation | Relative abundance % for order | Day 10 |
|
|
|
| Primary | Order Level Mean Proportional Relative Abundance | Order Level Mean Proportional Relative Abundance - Relative abundance % for order | Posted | Mean | Standard Deviation | Relative abundance % for order | Day 30 |
|
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 7 |
| 8 |
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Infusion arm discomfort | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Injection site reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| Title | Measurements |
|---|---|
|
| Euryarchaeota |
|
| Verrucomicrobiota |
|
| Proteobacteria |
|
| Other Phyla <2% |
|
| Title | Measurements |
|---|---|
|
| Euryarchaeota |
|
| Verrucomicrobiota |
|
| Proteobacteria |
|
| Other Phyla <2% |
|
| Title | Measurements |
|---|---|
|
| Euryarchaeota |
|
| Verrucomicrobiota |
|
| Proteobacteria |
|
| Other Phyla <2% |
|
|
| Prevotella |
|
| Eubacteria |
|
| Enterobacteriaceae |
|
|
| Prevotella |
|
| Eubacteria |
|
| Enterobacteriaceae |
|
|
| Prevotella |
|
| Eubacteria |
|
| Enterobacteriaceae |
|
|
| p_Euryarchaeota o_Methanobacteriales |
|
| p_Bacillota o_Erysipelotrichales |
|
| p_Bacillota o_Lachnospirales |
|
| p_Bacillota o_Lactobacillales |
|
| p_Bacillota o_Oscillospirales |
|
| p_Bacillota o_Peptostreptococcales- Tissierellales |
|
| p_Bacillota o_Veillonellales- Selenomonadales |
|
| p_Verrucomicrobiota o_Verrucomicrobiales |
|
| p_Proteobacteria o_Enterobacterales |
|
| Other Orders <2% |
|
|
| p_Euryarchaeota o_Methanobacteriales |
|
| p_Bacillota o_Erysipelotrichales |
|
| p_Bacillota o_Lachnospirales |
|
| p_Bacillota o_Lactobacillales |
|
| p_Bacillota o_Oscillospirales |
|
| p_Bacillota o_Peptostreptococcales- Tissierellales |
|
| p_Bacillota o_Veillonellales- Selenomonadales |
|
| p_Verrucomicrobiota o_Verrucomicrobiales |
|
| p_Proteobacteria o_Enterobacterales |
|
| Other Orders <2% |
|
|
| p_Euryarchaeota o_Methanobacteriales |
|
| p_Bacillota o_Erysipelotrichales |
|
| p_Bacillota o_Lachnospirales |
|
| p_Bacillota o_Lactobacillales |
|
| p_Bacillota o_Oscillospirales |
|
| p_Bacillota o_Peptostreptococcales- Tissierellales |
|
| p_Bacillota o_Veillonellales- Selenomonadales |
|
| p_Verrucomicrobiota o_Verrucomicrobiales |
|
| p_Proteobacteria o_Enterobacterales |
|
| Other Orders <2% |
|
|
| p_Euryarchaeota o_Methanobacteriales |
|
| p_Bacillota o_Erysipelotrichales |
|
| p_Bacillota o_Lachnospirales |
|
| p_Bacillota o_Lactobacillales |
|
| p_Bacillota o_Oscillospirales |
|
| p_Bacillota o_Peptostreptococcales- Tissierellales |
|
| p_Bacillota o_Veillonellales- Selenomonadales |
|
| p_Verrucomicrobiota o_Verrucomicrobiales |
|
| p_Proteobacteria o_Enterobacterales |
|
| Other Orders <2% |
|