Omadacycline for Bacterial Infections

Phase 1

Recruiting

Research Sponsored by Paratek Pharmaceuticals Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Currently hospitalized with a suspected or confirmed bacterial infection and receiving or planned to receive systemic antibiotic therapy other than omadacycline

Weight within the 5th and 95th percentile for age and sex

Must not have

Confirmed or suspected SARS-CoV-2 infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well omadacycline works in children with bacterial infections.

Who is the study for?

This trial is for hospitalized children and teens aged 8 to under 18 with suspected or confirmed bacterial infections. They must not be pregnant, agree to birth control if applicable, and fall within the normal weight range for their age and sex. They can't join if they have COVID-19, took experimental drugs recently, have a risky health condition, or are allergic to tetracycline antibiotics.

What is being tested?

The study tests how a single dose of Omadacycline (either as an oral tablet or injection) behaves in the bodies of young patients with bacterial infections. It aims to understand the correct dosage by observing how the drug is absorbed and processed.

What are the potential side effects?

Omadacycline may cause side effects similar to other antibiotics in its class which include nausea, vomiting, diarrhea, sun sensitivity, yeast infections in females, and possible tooth discoloration in younger children.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am in the hospital for a bacterial infection and will be treated with antibiotics, not including omadacycline.

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My weight is within the normal range for my age and sex.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have or might have COVID-19.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-dose, and 0.5, 1, 2, 8, and 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Characterize the PK of a single IV dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections

Characterize the PK of a single PO dose of omadacycline in children and adolescents 8 to < 18 years of age with suspected or confirmed bacterial infections

Secondary study objectives

Adverse events and serious adverse events

Clinical laboratory tests

Physical examination

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