Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacterial Infection Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Plovdiv, Bulgaria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Solithromycin

Drug

Other names: CEM-101

Primary outcomes

Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents

Time frame: 5 to 7 days

Sponsors and collaborators

Lead sponsor

Melinta Therapeutics, Inc.

Industry

Collaborators

Department of Health and Human Services

Registry information

Official study 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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Oct 20, 2014
Registry last updated: Jun 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed