Pharmacokinetics and Safety of Solithromycin in Adolescents and Children

June 7, 2017 updated by: Melinta Therapeutics, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Plovdiv, Bulgaria, 4002
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1606
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
    • California
      • Orange, California, United States, 92868
      • Palo Alto, California, United States, 94305
      • San Diego, California, United States, 92123
    • Florida
      • Jacksonville, Florida, United States, 32209
      • Tampa, Florida, United States, 33606
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Kansas
      • Wichita, Kansas, United States, 67214
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
    • Maryland
      • Baltimore, Maryland, United States, 21201
    • Missouri
      • Saint Louis, Missouri, United States, 63110
    • Nebraska
      • Omaha, Nebraska, United States, 68198
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • Albany, New York, United States, 12208
      • Brooklyn, New York, United States, 11203
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
    • Ohio
      • Cleveland, Ohio, United States, 44103
      • Toledo, Ohio, United States, 43606
    • Oregon
      • Portland, Oregon, United States, 97239
    • Tennessee
      • Memphis, Tennessee, United States, 38105-3678
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Austin, Texas, United States, 78723
      • Houston, Texas, United States, 77030
      • Splendora, Texas, United States, 77372
    • Virginia
      • Richmond, Virginia, United States, 23298
    • Washington
      • Seattle, Washington, United States, 98105
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: solithromycin
oral dosing (capsules and powder for suspension) by weight once per day intravenous dosing by weight once per day
Drug: solithromycin
Other Names:
  • CEM-101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration versus time curve (AUC) of solithromycin in children and adolescents
Time Frame: 5 to 7 days
5 to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Melinta Therapeutics, Inc.

Collaborators

Department of Health and Human Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

October 15, 2014

First Submitted That Met QC Criteria

October 15, 2014

First Posted (Estimate)

October 20, 2014

Study Record Updates

Last Update Posted (Actual)

June 9, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE01-120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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