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

Melinta Therapeutics

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Community-acquired Bacterial Pneumonia

Treatments: Drug: Standard of Care; Drug: Solithromycin

Study type: Interventional

Funder types: Industry; Other U.S. Federal agency

Identifiers

NCT02605122

CE01-203

Details and patient eligibility

About

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).

Full 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.

Enrollment: 97 patients

Sex: All

Ages: 2 months to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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97 participants in 2 patient groups

Solithromycin

Experimental group

Description:

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.

Treatment:

Drug: Solithromycin

Standard of Care

Active Comparator group

Description:

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.

Treatment:

Drug: Standard of Care