Effects of Intravenous (IV) Omadacycline on Gut Microbiome

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-20

Study Completion Date

2023-07-11

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Microbial Colonization

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intravenous (IV) Omadacycline

All participants will receive 5 days of IV omadacycline followed by 5 days of oral omadacycline

Group Type EXPERIMENTAL

Omadacycline Injection

Intervention Type DRUG

All participants will receive Intravenous (IV) omadacycline

Interventions

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Omadacycline Injection

All participants will receive Intravenous (IV) omadacycline

Intervention Type DRUG

Other Intervention Names

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Omadacycline oral

Eligibility Criteria

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Inclusion Criteria

* 18-40 years of age
* Willing and able to comply with all study procedures
* Considered healthy without history of cardiovascular, gastrointestinal, hepatic, or renal disease
* males or females - females of child bearing potential must agree to use a highly effective contraception during the study and for at least 7 days after the last dose of omadacycline

Exclusion Criteria

* Consumed probiotics within 30 days before enrollment
* Consumed antibiotics within 90 days prior to enrollment
* Known hypersensitivity to omadacycline or tetracycline-class antibiotics
* pregnant or breastfeeding
* in the opinion of the investigator is experiencing signs or symptoms of acute illness that increase the risk of adverse effects from participating in the study
* previously participated in the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes