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

NCT ID: NCT02605122

Last Updated: 2019-01-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 97 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2018-03-21

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).

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.

Conditions

Community-acquired Bacterial Pneumonia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Solithromycin

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

Age- and weight-based dosing as appropriate per sites standard of care.

Interventions

Solithromycin

Intervention Type: DRUG

Standard of Care

Age- and weight-based dosing as appropriate per sites standard of care.

Intervention Type: DRUG

Other Intervention Names

CEM-101; ceftriaxone; ampicillin; amoxicillin; amoxicillin-clavulanic acid; Azithromycin; Erythromycin; Erythromycin lactobionate

Eligibility 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

• Minimum Eligible Age: 2 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomedical Advanced Research and Development Authority

FED

Sponsor Role: collaborator

Melinta Therapeutics, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Cohen-Wolkowiez, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Clinical Research Institute

Locations

Little Rock, Arkansas, United States

Los Angeles, California, United States

Sacramento, California, United States

San Diego, California, United States

Washington D.C., District of Columbia, United States

Tampa, Florida, United States

Louisville, Kentucky, United States

Omaha, Nebraska, United States

Las Vegas, Nevada, United States

Durham, North Carolina, United States

Greenville, North Carolina, United States

Toledo, Ohio, United States

Portland, Oregon, United States

Hershey, Pennsylvania, United States

Memphis, Tennessee, United States

Amarillo, Texas, United States

Houston, Texas, United States

Splendora, Texas, United States

Charlottesville, Virginia, United States

Richmond, Virginia, United States

Roanoke, Virginia, United States

Pleven, , Bulgaria

Plovdiv, , Bulgaria

Rousse, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Sofia, , Bulgaria

Vratsa, , Bulgaria

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Budapest, , Hungary

Cegléd, , Hungary

Debrecen, , Hungary

Győr, , Hungary

Gyula, , Hungary

Mosdós, , Hungary

Nagykanizsa, , Hungary

Nyíregyháza, , Hungary

Szeged, , Hungary

Székesfehérvár, , Hungary

Törökbálint, , Hungary

Veszprém, , Hungary

Caloocan City, , Philippines

Cebu City, , Philippines

City of Muntinlupa, , Philippines

Davao City, , Philippines

Iloilo City, , Philippines

Manila, , Philippines

Quezon City, , Philippines

Quezon City, , Philippines

Esplugues de Llobregat, Barcelona, Spain

Donostia / San Sebastian, Guipuzcoa, Spain

Barcelona, , Spain

Barcelona, , Spain

Madrid, , Spain

London, , United Kingdom

London, , United Kingdom

Countries

United States; Bulgaria; Hungary; Philippines; Spain; United Kingdom

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CE01-203

Identifier Type: -

Identifier Source: org_study_id