Trial Outcomes & Findings for Healthy Patients & Effect of Antibiotics (NCT NCT03098485)
NCT ID: NCT03098485
Last Updated: 2022-11-10
Results Overview
The degree of microbial disruption will be defined by recovery of bacterial species richness (number of species) after antibiotics.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Decrease from baseline (7 days prior to antibiotics) in microbial diversity at 185 days post-antibiotics
Results posted on
2022-11-10
Participant Flow
Participant milestones
| Measure |
Levofloxacin
1 750mg tab of levofloxacin by mouth for 5 days
Levofloxacin: 5 days of levofloxacin administration
|
Azithromycin
1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Azithromycin: 5 days of azithromycin administration
|
Cefpodoxime
200mg tab by mouth twice per day for 5 days
Cefpodoxime: 5 days of cefpodoxime administration
|
Azithromycin and Cefpodoxime
Azithromycin: 1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Cefpodoxime: 200mg tab by mouth twice per day for 5 days
Azithromycin: 5 days of azithromycin administration
Cefpodoxime: 5 days of cefpodoxime administration
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
5
|
5
|
|
Overall Study
COMPLETED
|
5
|
5
|
5
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Healthy Patients & Effect of Antibiotics
Baseline characteristics by cohort
| Measure |
Levofloxacin
n=5 Participants
1 750mg tab of levofloxacin by mouth for 5 days
Levofloxacin: 5 days of levofloxacin administration
|
Azithromycin
n=5 Participants
1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Azithromycin: 5 days of azithromycin administration
|
Cefpodoxime
n=5 Participants
200mg tab by mouth twice per day for 5 days
Cefpodoxime: 5 days of cefpodoxime administration
|
Azithromycin and Cefpodoxime
n=5 Participants
Azithromycin: 1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Cefpodoxime: 200mg tab by mouth twice per day for 5 days
Azithromycin: 5 days of azithromycin administration
Cefpodoxime: 5 days of cefpodoxime administration
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
Age (years)
|
41 years
n=5 Participants
|
27 years
n=7 Participants
|
39 years
n=5 Participants
|
34 years
n=4 Participants
|
37 years
n=21 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
5 participants
n=5 Participants
|
5 participants
n=7 Participants
|
5 participants
n=5 Participants
|
5 participants
n=4 Participants
|
20 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Decrease from baseline (7 days prior to antibiotics) in microbial diversity at 185 days post-antibioticsThe degree of microbial disruption will be defined by recovery of bacterial species richness (number of species) after antibiotics.
Outcome measures
| Measure |
Levofloxacin
n=5 Participants
1 750mg tab of levofloxacin by mouth for 5 days
Levofloxacin: 5 days of levofloxacin administration
|
Azithromycin
n=5 Participants
1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Azithromycin: 5 days of azithromycin administration
|
Cefpodoxime
n=5 Participants
200mg tab by mouth twice per day for 5 days
Cefpodoxime: 5 days of cefpodoxime administration
|
Azithromycin and Cefpodoxime
n=5 Participants
Azithromycin: 1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Cefpodoxime: 200mg tab by mouth twice per day for 5 days
Azithromycin: 5 days of azithromycin administration
Cefpodoxime: 5 days of cefpodoxime administration
|
|---|---|---|---|---|
|
Degree of Microbial Disruption: Number of Patients With Recovery of Bacterial Species Richness at 185 Days Post-antibiotics
|
3 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Increase from baseline (7 days prior to antibiotics) in antibiotic resistance genes at 185 days post-antibioticsThe degree of microbiome disruptions will be defined by an increase in the number of antibiotic resistance genes after antibiotics compared to baseline.
Outcome measures
| Measure |
Levofloxacin
n=5 Participants
1 750mg tab of levofloxacin by mouth for 5 days
Levofloxacin: 5 days of levofloxacin administration
|
Azithromycin
n=5 Participants
1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Azithromycin: 5 days of azithromycin administration
|
Cefpodoxime
n=5 Participants
200mg tab by mouth twice per day for 5 days
Cefpodoxime: 5 days of cefpodoxime administration
|
Azithromycin and Cefpodoxime
n=5 Participants
Azithromycin: 1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Cefpodoxime: 200mg tab by mouth twice per day for 5 days
Azithromycin: 5 days of azithromycin administration
Cefpodoxime: 5 days of cefpodoxime administration
|
|---|---|---|---|---|
|
Degree of Microbial Disruption: Number of Patients With Increase in Antibiotic Resistance Genes at 185 Days Post-antibiotics
|
4 Participants
|
5 Participants
|
5 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Persistent disruption from baseline (7 days prior to antibiotics) in microbial composition at 185 days post-antibioticsThe degree of microbiome disruptions will be defined by continuing microbial disruption, as measured by Bray-Curtis dissimilarity, post-antibiotics compared to baseline.
Outcome measures
| Measure |
Levofloxacin
n=5 Participants
1 750mg tab of levofloxacin by mouth for 5 days
Levofloxacin: 5 days of levofloxacin administration
|
Azithromycin
n=5 Participants
1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Azithromycin: 5 days of azithromycin administration
|
Cefpodoxime
n=5 Participants
200mg tab by mouth twice per day for 5 days
Cefpodoxime: 5 days of cefpodoxime administration
|
Azithromycin and Cefpodoxime
n=5 Participants
Azithromycin: 1 500mg tab by mouth on day 1, then 1 250 mg tab per day by mouth for 4 days (total 5 days)
Cefpodoxime: 200mg tab by mouth twice per day for 5 days
Azithromycin: 5 days of azithromycin administration
Cefpodoxime: 5 days of cefpodoxime administration
|
|---|---|---|---|---|
|
Degree of Microbial Disruption: Number of Patients With Continued Microbial Disruption at 185 Days Post-antibiotics
|
4 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
Adverse Events
Levofloxacin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azithromycin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cefpodoxime
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Azithromycin and Cefpodoxime
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kimberly Reske, MPH
Washington University in St. Louis School of Medicine
Phone: 3147474041
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place