Trial Outcomes & Findings for Effects of Intravenous (IV) Omadacycline on Gut Microbiome (NCT NCT05515562)
NCT ID: NCT05515562
Last Updated: 2025-03-17
Results Overview
In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
8 participants
Primary outcome timeframe
Day 30
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Intravenous (IV) Omadacycline on Gut Microbiome
Baseline characteristics by cohort
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Age, Continuous
|
29.875 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 30In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Phylum Level Mean Proportional Relative Abundance
Actinobacteriota
|
0.167 % gram positive (+) for phylum
Standard Deviation 0.0622
|
|
Phylum Level Mean Proportional Relative Abundance
Bacteroidota
|
0.0271 % gram positive (+) for phylum
Standard Deviation 0.0314
|
|
Phylum Level Mean Proportional Relative Abundance
Bacillota
|
0.686 % gram positive (+) for phylum
Standard Deviation 0.114
|
|
Phylum Level Mean Proportional Relative Abundance
Euryarchaeota
|
0.0391 % gram positive (+) for phylum
Standard Deviation 0.103
|
|
Phylum Level Mean Proportional Relative Abundance
Verrucomicrobiota
|
0.0371 % gram positive (+) for phylum
Standard Deviation 0.0750
|
|
Phylum Level Mean Proportional Relative Abundance
Proteobacteria
|
0.0399 % gram positive (+) for phylum
Standard Deviation 0.0610
|
|
Phylum Level Mean Proportional Relative Abundance
Other Phyla <2%
|
0.00324 % gram positive (+) for phylum
Standard Deviation 0.00809
|
PRIMARY outcome
Timeframe: BaselineIn general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Phylum Level Mean Proportional Relative Abundance
Actinobacteriota
|
0.130 % gram positive (+) for phylum
Standard Deviation 0.0390
|
|
Phylum Level Mean Proportional Relative Abundance
Bacteroidota
|
0.0135 % gram positive (+) for phylum
Standard Deviation 0.0152
|
|
Phylum Level Mean Proportional Relative Abundance
Bacillota
|
0.779 % gram positive (+) for phylum
Standard Deviation 0.0879
|
|
Phylum Level Mean Proportional Relative Abundance
Euryarchaeota
|
0.0388 % gram positive (+) for phylum
Standard Deviation 0.0933
|
|
Phylum Level Mean Proportional Relative Abundance
Verrucomicrobiota
|
0.0173 % gram positive (+) for phylum
Standard Deviation 0.0227
|
|
Phylum Level Mean Proportional Relative Abundance
Proteobacteria
|
0.0205 % gram positive (+) for phylum
Standard Deviation 0.0342
|
|
Phylum Level Mean Proportional Relative Abundance
Other Phyla <2%
|
0.00110 % gram positive (+) for phylum
Standard Deviation 0.00190
|
PRIMARY outcome
Timeframe: Day 5In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Phylum Level Mean Proportional Relative Abundance
Actinobacteriota
|
0.225 % gram positive (+) for phylum
Standard Deviation 0.0469
|
|
Phylum Level Mean Proportional Relative Abundance
Bacteroidota
|
0.0507 % gram positive (+) for phylum
Standard Deviation 0.0812
|
|
Phylum Level Mean Proportional Relative Abundance
Bacillota
|
0.432 % gram positive (+) for phylum
Standard Deviation 0.0814
|
|
Phylum Level Mean Proportional Relative Abundance
Euryarchaeota
|
0 % gram positive (+) for phylum
Standard Deviation 0.0001
|
|
Phylum Level Mean Proportional Relative Abundance
Verrucomicrobiota
|
0.131 % gram positive (+) for phylum
Standard Deviation 0.106
|
|
Phylum Level Mean Proportional Relative Abundance
Proteobacteria
|
0.158 % gram positive (+) for phylum
Standard Deviation 0.141
|
|
Phylum Level Mean Proportional Relative Abundance
Other Phyla <2%
|
0.00310 % gram positive (+) for phylum
Standard Deviation 0.00407
|
PRIMARY outcome
Timeframe: Day 10In general, the healthy volunteer analyses will assess changes in total and species-specific microbiota over time as well as changes in microbial diversity.
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Phylum Level Mean Proportional Relative Abundance
Actinobacteriota
|
0.198 % gram positive (+) for phylum
Standard Deviation 0.101
|
|
Phylum Level Mean Proportional Relative Abundance
Bacteroidota
|
0.0459 % gram positive (+) for phylum
Standard Deviation 0.0848
|
|
Phylum Level Mean Proportional Relative Abundance
Bacillota
|
0.246 % gram positive (+) for phylum
Standard Deviation 0.191
|
|
Phylum Level Mean Proportional Relative Abundance
Euryarchaeota
|
0.152 % gram positive (+) for phylum
Standard Deviation 0.262
|
|
Phylum Level Mean Proportional Relative Abundance
Verrucomicrobiota
|
0.210 % gram positive (+) for phylum
Standard Deviation 0.203
|
|
Phylum Level Mean Proportional Relative Abundance
Proteobacteria
|
0.147 % gram positive (+) for phylum
Standard Deviation 0.112
|
|
Phylum Level Mean Proportional Relative Abundance
Other Phyla <2%
|
0.00105 % gram positive (+) for phylum
Standard Deviation 0.00144
|
PRIMARY outcome
Timeframe: Baselinenanograms (ng) per gram of stool for bacterial DNA
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Bacterial DNA Per Gram of Stool
Bacteroides thetaiotaomicron
|
2.74 10^7 ng/g
Standard Deviation 6.11
|
|
Bacterial DNA Per Gram of Stool
Blautia coccoides
|
608 10^7 ng/g
Standard Deviation 2.39
|
|
Bacterial DNA Per Gram of Stool
Clostridium leptum
|
3.84 10^7 ng/g
Standard Deviation 1.73
|
|
Bacterial DNA Per Gram of Stool
Prevotella
|
14.9 10^7 ng/g
Standard Deviation 46.6
|
|
Bacterial DNA Per Gram of Stool
Eubacteria
|
2220 10^7 ng/g
Standard Deviation 953
|
|
Bacterial DNA Per Gram of Stool
Enterobacteriaceae
|
1.42 10^7 ng/g
Standard Deviation 5.57
|
PRIMARY outcome
Timeframe: During Therapy up to Day 6nanograms (ng) per gram of stool for bacterial DNA
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Bacterial DNA Per Gram of Stool
Bacteroides thetaiotaomicron
|
.954 10^7 ng/g
Standard Deviation 3.05
|
|
Bacterial DNA Per Gram of Stool
Blautia coccoides
|
30.0 10^7 ng/g
Standard Deviation 22.9
|
|
Bacterial DNA Per Gram of Stool
Clostridium leptum
|
.0488 10^7 ng/g
Standard Deviation .0553
|
|
Bacterial DNA Per Gram of Stool
Prevotella
|
2.41 10^7 ng/g
Standard Deviation 22.8
|
|
Bacterial DNA Per Gram of Stool
Eubacteria
|
197 10^7 ng/g
Standard Deviation 157
|
|
Bacterial DNA Per Gram of Stool
Enterobacteriaceae
|
9.77 10^7 ng/g
Standard Deviation 31.5
|
PRIMARY outcome
Timeframe: End of Therapy up to Day 10nanograms (ng) per gram of stool for bacterial DNA
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Bacterial DNA Per Gram of Stool
Blautia coccoides
|
9.97 10^7 ng/g
Standard Deviation 14.7
|
|
Bacterial DNA Per Gram of Stool
Bacteroides thetaiotaomicron
|
0.849 10^7 ng/g
Standard Deviation 1.43
|
|
Bacterial DNA Per Gram of Stool
Clostridium leptum
|
.0148 10^7 ng/g
Standard Deviation .0130
|
|
Bacterial DNA Per Gram of Stool
Prevotella
|
4.25 10^7 ng/g
Standard Deviation 7.30
|
|
Bacterial DNA Per Gram of Stool
Eubacteria
|
103 10^7 ng/g
Standard Deviation 113
|
|
Bacterial DNA Per Gram of Stool
Enterobacteriaceae
|
21.9 10^7 ng/g
Standard Deviation 37.4
|
PRIMARY outcome
Timeframe: BaselineOrder Level Mean Proportional Relative Abundance - Relative abundance % for order
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Order Level Mean Proportional Relative Abundance
p_Actinobacteriota o_Bifidobacteriales
|
0.0349 Relative abundance % for order
Standard Deviation 0.0265
|
|
Order Level Mean Proportional Relative Abundance
p_Actinobacteriota o_Coriobacteriales
|
0.0925 Relative abundance % for order
Standard Deviation 0.0389
|
|
Order Level Mean Proportional Relative Abundance
p_Bacteroidota o_Bacteroidales
|
0.0135 Relative abundance % for order
Standard Deviation 0.0152
|
|
Order Level Mean Proportional Relative Abundance
p_Euryarchaeota o_Methanobacteriales
|
0.0388 Relative abundance % for order
Standard Deviation 0.0933
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Erysipelotrichales
|
0.0693 Relative abundance % for order
Standard Deviation 00622
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Lachnospirales
|
0.417 Relative abundance % for order
Standard Deviation 0.157
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Lactobacillales
|
0.0429 Relative abundance % for order
Standard Deviation 0.0273
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Oscillospirales
|
0.188 Relative abundance % for order
Standard Deviation 0.0883
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Peptostreptococcales- Tissierellales
|
0.0213 Relative abundance % for order
Standard Deviation 0.0109
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Veillonellales- Selenomonadales
|
0.0107 Relative abundance % for order
Standard Deviation 0.00754
|
|
Order Level Mean Proportional Relative Abundance
p_Verrucomicrobiota o_Verrucomicrobiales
|
0.0173 Relative abundance % for order
Standard Deviation 0.0227
|
|
Order Level Mean Proportional Relative Abundance
p_Proteobacteria o_Enterobacterales
|
0.0204 Relative abundance % for order
Standard Deviation 0.0342
|
|
Order Level Mean Proportional Relative Abundance
Other Orders <2%
|
0.0336 Relative abundance % for order
Standard Deviation 0.0320
|
PRIMARY outcome
Timeframe: Day 5Order Level Mean Proportional Relative Abundance - Relative abundance % for order
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Order Level Mean Proportional Relative Abundance
p_Actinobacteriota o_Bifidobacteriales
|
0.105 Relative abundance % for order
Standard Deviation 0.0358
|
|
Order Level Mean Proportional Relative Abundance
p_Actinobacteriota o_Coriobacteriales
|
0.120 Relative abundance % for order
Standard Deviation 0.0314
|
|
Order Level Mean Proportional Relative Abundance
p_Bacteroidota o_Bacteroidales
|
0.0507 Relative abundance % for order
Standard Deviation 0.0812
|
|
Order Level Mean Proportional Relative Abundance
p_Euryarchaeota o_Methanobacteriales
|
0.000447 Relative abundance % for order
Standard Deviation 0.0001
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Erysipelotrichales
|
0.0148 Relative abundance % for order
Standard Deviation 0.0143
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Lachnospirales
|
0.204 Relative abundance % for order
Standard Deviation 0.0845
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Lactobacillales
|
0.0505 Relative abundance % for order
Standard Deviation 0.0632
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Oscillospirales
|
0.0653 Relative abundance % for order
Standard Deviation 0.0507
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Peptostreptococcales- Tissierellales
|
0.0163 Relative abundance % for order
Standard Deviation 0.0161
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Veillonellales- Selenomonadales
|
0.0685 Relative abundance % for order
Standard Deviation 0.0881
|
|
Order Level Mean Proportional Relative Abundance
p_Verrucomicrobiota o_Verrucomicrobiales
|
0.131 Relative abundance % for order
Standard Deviation 0.106
|
|
Order Level Mean Proportional Relative Abundance
p_Proteobacteria o_Enterobacterales
|
0.158 Relative abundance % for order
Standard Deviation 0.141
|
|
Order Level Mean Proportional Relative Abundance
Other Orders <2%
|
0.0175 Relative abundance % for order
Standard Deviation 0.0168
|
PRIMARY outcome
Timeframe: Day 10Order Level Mean Proportional Relative Abundance - Relative abundance % for order
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Order Level Mean Proportional Relative Abundance
p_Actinobacteriota o_Bifidobacteriales
|
0.164 Relative abundance % for order
Standard Deviation 0.0979
|
|
Order Level Mean Proportional Relative Abundance
p_Actinobacteriota o_Coriobacteriales
|
0.0324 Relative abundance % for order
Standard Deviation 0.0368
|
|
Order Level Mean Proportional Relative Abundance
p_Bacteroidota o_Bacteroidales
|
0.0459 Relative abundance % for order
Standard Deviation 0.0848
|
|
Order Level Mean Proportional Relative Abundance
p_Euryarchaeota o_Methanobacteriales
|
0.152 Relative abundance % for order
Standard Deviation 0.262
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Erysipelotrichales
|
0.229 Relative abundance % for order
Standard Deviation 0.0546
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Lachnospirales
|
0.0616 Relative abundance % for order
Standard Deviation 0.0473
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Lactobacillales
|
0.0128 Relative abundance % for order
Standard Deviation 0.0104
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Oscillospirales
|
0.0363 Relative abundance % for order
Standard Deviation 0.0725
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Peptostreptococcales- Tissierellales
|
0.0156 Relative abundance % for order
Standard Deviation 0.0238
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Veillonellales- Selenomonadales
|
0.0915 Relative abundance % for order
Standard Deviation 0.142
|
|
Order Level Mean Proportional Relative Abundance
p_Verrucomicrobiota o_Verrucomicrobiales
|
0.210 Relative abundance % for order
Standard Deviation 0.203
|
|
Order Level Mean Proportional Relative Abundance
p_Proteobacteria o_Enterobacterales
|
0.147 Relative abundance % for order
Standard Deviation 0.112
|
|
Order Level Mean Proportional Relative Abundance
Other Orders <2%
|
0.00783 Relative abundance % for order
Standard Deviation 0.00772
|
PRIMARY outcome
Timeframe: Day 30Order Level Mean Proportional Relative Abundance - Relative abundance % for order
Outcome measures
| Measure |
Intravenous (IV) Omadacycline
n=8 Participants
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
|
|---|---|
|
Order Level Mean Proportional Relative Abundance
p_Bacteroidota o_Bacteroidales
|
0.0270 Relative abundance % for order
Standard Deviation 0.0313
|
|
Order Level Mean Proportional Relative Abundance
p_Actinobacteriota o_Bifidobacteriales
|
0.0880 Relative abundance % for order
Standard Deviation 0.0515
|
|
Order Level Mean Proportional Relative Abundance
p_Actinobacteriota o_Coriobacteriales
|
0.0779 Relative abundance % for order
Standard Deviation 0.0530
|
|
Order Level Mean Proportional Relative Abundance
p_Euryarchaeota o_Methanobacteriales
|
0.0391 Relative abundance % for order
Standard Deviation 0.103
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Erysipelotrichales
|
0.0356 Relative abundance % for order
Standard Deviation 0.0365
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Lachnospirales
|
0.416 Relative abundance % for order
Standard Deviation 0.169
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Lactobacillales
|
0.0306 Relative abundance % for order
Standard Deviation 0.0265
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Oscillospirales
|
0.0971 Relative abundance % for order
Standard Deviation 0.0941
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Peptostreptococcales- Tissierellales
|
0.0271 Relative abundance % for order
Standard Deviation 0.0197
|
|
Order Level Mean Proportional Relative Abundance
p_Bacillota o_Veillonellales- Selenomonadales
|
0.0657 Relative abundance % for order
Standard Deviation 0.119
|
|
Order Level Mean Proportional Relative Abundance
p_Verrucomicrobiota o_Verrucomicrobiales
|
0.0371 Relative abundance % for order
Standard Deviation 0.0750
|
|
Order Level Mean Proportional Relative Abundance
p_Proteobacteria o_Enterobacterales
|
0.0400 Relative abundance % for order
Standard Deviation 0.0611
|
|
Order Level Mean Proportional Relative Abundance
Other Orders <2%
|
0.0186 Relative abundance % for order
Standard Deviation 0.0198
|
Adverse Events
Intravenous (IV) Omadacycline
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intravenous (IV) Omadacycline
n=8 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
87.5%
7/8 • Number of events 7 • 31 days
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
25.0%
2/8 • Number of events 2 • 31 days
|
|
Skin and subcutaneous tissue disorders
Infusion arm discomfort
|
37.5%
3/8 • Number of events 3 • 31 days
|
|
Skin and subcutaneous tissue disorders
Injection site reaction
|
12.5%
1/8 • Number of events 1 • 31 days
|
Additional Information
John Williamson, PharmD
Wake Forest University Health Sciences
Phone: 336.713.3431
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place