Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia

December 12, 2018 updated by: Melinta Therapeutics, Inc.

A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents and Children With Suspected or Confirmed Community-Acquired Bacterial Pneumonia

This is a phase 2/3, randomized, open-label, active control, multi-center study to assess the safety and efficacy of solithromycin in children and adolescents with community-acquired bacterial pneumonia (CABP).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Subjects who meet all inclusion/exclusion criteria and sign the informed consent/assent were enrolled. Subjects were randomized to receive solithromycin or a comparator antibiotic, administered IV and/or by mouth (PO) based on weight and age. Subjects were treated daily for 5 to 7 days with oral solithromycin and 5 to 7 days with IV or IV-to-oral solithromycin. Subjects were treated for 5 to 10 days with comparator antibiotics. Subjects received safety and efficacy assessments during and after treatment.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
97

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

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
      • Pleven, Bulgaria, 5800
      • Plovdiv, Bulgaria, 4000
      • Ruse, Bulgaria, 7002
      • Sofia, Bulgaria, 1233
      • Sofia, Bulgaria, 1431
      • Sofia, Bulgaria, 1407
      • Vratsa, Bulgaria, 3001
  • Hungary
      • Budapest, Hungary, 1125
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1097
      • Budapest, Hungary, 1089
      • Cegléd, Hungary, 2700
      • Debrecen, Hungary, 4031
      • Gyor, Hungary, 9024
      • Gyula, Hungary, 5700
      • Mosdós, Hungary, 7257
      • Nagykanizsa, Hungary, 8800
      • Nyiregyhaza, Hungary, 4400
      • Szeged, Hungary, 6720
      • Szekesfehervar, Hungary, 8000
      • Torokbalint, Hungary, 2045
      • Veszprém, Hungary, 8200
  • Philippines
      • Caloocan City, Philippines, 1400
      • Cebu City, Philippines, 6000
      • Davao City, Philippines, 8000
      • Iloilo, Philippines, 5000
      • Manila, Philippines, 1000
      • Muntinlupa, Philippines, 1781
      • Quezon City, Philippines, 1100
      • Quezon City, Philippines, 1104
  • Spain
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08916
      • Madrid, Spain, 28046
    • Barcelona
      • Esplugues de Llobregat, Barcelona, Spain, 08950
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20014
  • United Kingdom
      • London, United Kingdom, SW17 0RE
      • London, United Kingdom, N18 1QX
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72202
    • California
      • Los Angeles, California, United States, 90095
      • Sacramento, California, United States, 95817
      • San Diego, California, United States, 92123
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • Florida
      • Tampa, Florida, United States, 33606
    • Kentucky
      • Louisville, Kentucky, United States, 40202
    • Nebraska
      • Omaha, Nebraska, United States, 68198-2162
    • Nevada
      • Las Vegas, Nevada, United States, 89102
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Greenville, North Carolina, United States, 27834
    • Ohio
      • Toledo, Ohio, United States, 43606
    • Oregon
      • Portland, Oregon, United States, 97239
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
    • Tennessee
      • Memphis, Tennessee, United States, 38105
    • Texas
      • Amarillo, Texas, United States, 79106
      • Houston, Texas, United States, 77030
      • Splendora, Texas, United States, 77372
    • Virginia
      • Charlottesville, Virginia, United States, 22905
      • Richmond, Virginia, United States, 29298
      • Roanoke, Virginia, United States, 24013

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 months to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • History of and/or documented fever (rectal, ear, or oral temperature ≥38°C or axillary temperature ≥37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C or axillary temperature <34.5°C)
  • Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia caused by atypical bacterial agents); if a subject is outpatient and starting on oral therapy, a radiograph is not required.
  • Presence of at least 2 of the following signs or symptoms:
  • Cough
  • Difficulty breathing
  • Production of purulent sputum
  • Chest pain
  • Grunting
  • Hypotension

  • Tachycardia, defined as follows:

    2 months to <24 months: ≥160 beats/min 24 months to <10 years: ≥140 beats/min

    • 10 years: ≥100 beats/min

  • Tachypnea, defined as follows:

    2 months to <12 months: ≥50 breaths/min 12 months to <5 years: ≥40 breaths/min

    • 5 years: ≥20 breaths/min
  • Physical exam consistent with pulmonary consolidation
  • Presence of at least 1 of the following:
  • Leukocytosis (≥12,000 white blood cells [WBC]/mm3)
  • Leukopenia (<5000 WBC/mm3)
  • ≥10% immature neutrophils (bands) regardless of total peripheral WBC
  • Elevated inflammatory markers (C-reactive protein or procalcitonin)
  • Oxygen saturation <97% on room air
  • Organism consistent with a typical respiratory pathogen identified

Exclusion Criteria:

  • Ventilator-associated or hospital-acquired pneumonia
  • >48 hours of systemic antibacterial therapy
  • confirmed or suspected bacterial meningitis
  • breast-feeding females
  • positive pregnancy test

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Solithromycin
Solithromycin will be administered orally, as capsules or as a suspension, or intravenously. Patients may receive intravenous therapy initially and switch to an oral formulation. Dosage is weight based and age based.
Drug: Solithromycin
Other Names:
  • CEM-101
Active Comparator: Standard of Care
Comparators will be selected according to subject age and are consistent with current recommendations for treatment of CABP in children. These include intravenous ceftriaxone, ampicillin, and amoxicillin and oral amoxicillin and amoxicillin-clavulanic acid. Azithromycin or erythromycin may be added as well.
Drug: Standard of Care
Age- and weight-based dosing as appropriate per sites standard of care.
Other Names:
  • Erythromycin
  • ampicillin
  • amoxicillin
  • Azithromycin
  • ceftriaxone
  • amoxicillin-clavulanic acid
  • Erythromycin lactobionate

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overview of Adverse Events By Treatment Arm
Time Frame: Up to 28 days post-treatment
Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization)
Up to 28 days post-treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Summary of Early Clinical Response
Time Frame: During Treatment Days 3 to 4
Early clinical response (ECR) was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic.
During Treatment Days 3 to 4
Summary of Clinical Improvement
Time Frame: Last day of Treatment (+48 hours)
Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+48 hours), and was defined identically to the early clinical response.
Last day of Treatment (+48 hours)
Summary of Clinical Cure
Time Frame: Short-term follow-up at 16 days (+/- 4 days)
Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (+/- 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic.
Short-term follow-up at 16 days (+/- 4 days)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Melinta Therapeutics, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biomedical Advanced Research and Development Authority

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Cohen-Wolkowiez, MD, PhD, Duke Clinical Research Institute

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 21, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 21, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 10, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 16, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 3, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE01-203

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

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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