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Trial record 90 of 180 for:    ERYTHROMYCIN

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

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ClinicalTrials.gov Identifier: NCT02605122
Recruitment Status : Terminated (Development not proceeding)
First Posted : November 16, 2015
Results First Posted : January 3, 2019
Last Update Posted : January 3, 2019
Sponsor:
Collaborator:
Biomedical Advanced Research and Development Authority
Information provided by (Responsible Party):
Melinta Therapeutics, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Community-acquired Bacterial Pneumonia Drug: Solithromycin Drug: Standard of Care Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: A healthcare provider designated as a sub-investigator blinded to treatment allocation at the site documented clinical response at specified time points during the study.
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : April 2016
Actual Primary Completion Date : March 21, 2018
Actual Study Completion Date : March 21, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
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 Name: 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:
  • ceftriaxone
  • ampicillin
  • amoxicillin
  • amoxicillin-clavulanic acid
  • Azithromycin
  • Erythromycin
  • Erythromycin lactobionate




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02605122


  Show 58 Study Locations
Sponsors and Collaborators
Melinta Therapeutics, Inc.
Biomedical Advanced Research and Development Authority
Investigators
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Principal Investigator: Michael Cohen-Wolkowiez, MD, PhD Duke Clinical Research Institute
  Study Documents (Full-Text)

Documents provided by Melinta Therapeutics, Inc.:
Study Protocol  [PDF] November 29, 2017
Statistical Analysis Plan  [PDF] May 14, 2018


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Responsible Party: Melinta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02605122     History of Changes
Other Study ID Numbers: CE01-203
First Posted: November 16, 2015    Key Record Dates
Results First Posted: January 3, 2019
Last Update Posted: January 3, 2019
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Melinta Therapeutics, Inc.:
pneumonia
macrolide
pediatric
Additional relevant MeSH terms:
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Erythromycin
Erythromycin Estolate
Erythromycin Ethylsuccinate
Erythromycin stearate
Erythromycin lactobionate
Pneumonia, Bacterial
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Bacterial Infections
Amoxicillin
Ceftriaxone
Clavulanic Acids
Clavulanic Acid
Ampicillin
Amoxicillin-Potassium Clavulanate Combination
Solithromycin
Anti-Bacterial Agents
Anti-Infective Agents
Gastrointestinal Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
beta-Lactamase Inhibitors