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NCT02268279 Clinical Trial

Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

Bacterial Infection Clinical Trial

Official title:
A Phase 1, Open-label, Multi-center Study to Determine the Pharmacokinetics and Safety of Solithromycin as Add-on Therapy in Adolescents and Children With Suspected or Confirmed Bacterial Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02268279
Other study ID # CE01-120
Secondary ID
Status Completed
Phase Phase 1
First received October 15, 2014
Last updated June 7, 2017
Start date January 2015
Est. completion date October 2016

Study information
Verified date June 2017
Source Cempra Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Pediatric study to evaluate the safety and pharmacokinetics of solithromycin (oral and intravenous) in children ages 0 to 17

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active.

Exclusion Criteria:

- Serum creatinine >2 mg/dL

- Positive pregnancy test in females of childbearing potential

- History of intolerance or hypersensitivity to macrolide antibiotics

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• solithromycin

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Cempra Inc Department of Health and Human Services

Countries where clinical trial is conducted

United States,  Bulgaria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents 5 to 7 days
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