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

Last updated: December 12, 2018
Sponsor: Melinta Therapeutics, Inc.
Overall Status: Terminated

Phase

2/3

Condition

Pneumonia

Treatment

N/A

Clinical Study ID

NCT02605122
CE01-203
  • Ages 2-17
  • All Genders

Study Summary

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • History of and/or documented fever (rectal, ear, or oral temperature ≥38°C or axillarytemperature ≥37.5°C) or hypothermia (rectal, ear, or oral temperature <35°C oraxillary temperature <34.5°C)

  • Chest radiograph infiltrates consistent with bacterial pneumonia (or pneumonia causedby atypical bacterial agents); if a subject is outpatient and starting on oraltherapy, 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

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 Design

Total Participants: 97
Study Start date:
April 01, 2016
Estimated Completion Date:
March 21, 2018

Study 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.

Connect with a study center

  • Pleven, 5800
    Bulgaria

    Site Not Available

  • Plovdiv, 4000
    Bulgaria

    Site Not Available

  • Ruse, 7002
    Bulgaria

    Site Not Available

  • Sofia, 1407
    Bulgaria

    Site Not Available

  • Vratsa, 3001
    Bulgaria

    Site Not Available

  • Budapest, 1083
    Hungary

    Site Not Available

  • Cegléd, 2700
    Hungary

    Site Not Available

  • Debrecen, 4031
    Hungary

    Site Not Available

  • Gyor, 9024
    Hungary

    Site Not Available

  • Gyula, 5700
    Hungary

    Site Not Available

  • Mosdós, 7257
    Hungary

    Site Not Available

  • Nagykanizsa, 8800
    Hungary

    Site Not Available

  • Nyiregyhaza, 4400
    Hungary

    Site Not Available

  • Szeged, 6720
    Hungary

    Site Not Available

  • Szekesfehervar, 8000
    Hungary

    Site Not Available

  • Torokbalint, 2045
    Hungary

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  • Veszprém, 8200
    Hungary

    Site Not Available

  • empty

    Caloo City, Metro Manila 1400
    Philippines

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  • empty

    Muntinlupa City, Metro Manila 1781
    Philippines

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  • Caloocan City, 1400
    Philippines

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  • Cebu City, 6000
    Philippines

    Site Not Available

  • Davao City, 8000
    Philippines

    Site Not Available

  • Iloilo, 5000
    Philippines

    Site Not Available

  • Manila, 1000
    Philippines

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  • Muntinlupa, 1781
    Philippines

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  • Quezon City, 1100
    Philippines

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    Esplugas de Llobregat, Barcelona 08950
    Spain

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  • Esplugues de Llobregat, Barcelona 08950
    Spain

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  • San Sebastian, Guipuzcoa 20014
    Spain

    Site Not Available

  • Barcelona, 08035
    Spain

    Site Not Available

  • Madrid, 28046
    Spain

    Site Not Available

  • London, N18 1QX
    United Kingdom

    Site Not Available

  • Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Los Angeles, California 90095
    United States

    Site Not Available

  • Sacramento, California 95817
    United States

    Site Not Available

  • San Diego, California 92123
    United States

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  • Washington, District of Columbia 20010
    United States

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  • Tampa, Florida 33606
    United States

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  • Louisville, Kentucky 40202
    United States

    Site Not Available

  • Omaha, Nebraska 68198-2162
    United States

    Site Not Available

  • Las Vegas, Nevada 89102
    United States

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  • Durham, North Carolina 27710
    United States

    Site Not Available

  • Greenville, North Carolina 27834
    United States

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  • empty

    Cleveland, Ohio 44106
    United States

    Site Not Available

  • Toledo, Ohio 43606
    United States

    Site Not Available

  • Portland, Oregon 97239
    United States

    Site Not Available

  • Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Memphis, Tennessee 38105
    United States

    Site Not Available

  • Amarillo, Texas 79106
    United States

    Site Not Available

  • Houston, Texas 77030
    United States

    Site Not Available

  • Splendora, Texas 77372
    United States

    Site Not Available

  • Charlottesville, Virginia 22905
    United States

    Site Not Available

  • Richmond, Virginia 29298
    United States

    Site Not Available

  • Roanoke, Virginia 24013
    United States

    Site Not Available

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