Clinical trial NCT02605122: Safety and Efficacy of Solithromycin in Adolescents and Children With Community-Acquired Bacterial Pneumonia
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Community-acquired Bacterial Pneumonia
Keywords: pneumonia
macrolide
pediatric
Lead sponsor: Melinta Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biomedical Advanced Research and Development Authority
First posted: 2015-11-16
Enrollment: 97
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Overview of Adverse Events By Treatment Arm
timeFrame: Up to 28 days post-treatment
Secondary outcomes:
measure: Summary of Early Clinical Response
timeFrame: During Treatment Days 3 to 4
measure: Summary of Clinical Improvement
timeFrame: Last day of Treatment (+48 hours)
measure: Summary of Clinical Cure
timeFrame: Short-term follow-up at 16 days (+/- 4 days)
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Los Angeles
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Tampa
country: United States
state: Florida
city: Louisville
country: United States
state: Kentucky
city: Omaha
country: United States
state: Nebraska
city: Las Vegas
country: United States
state: Nevada
city: Durham
country: United States
state: North Carolina
city: Greenville
country: United States
state: North Carolina
city: Toledo
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Hershey
country: United States
state: Pennsylvania
city: Memphis
country: United States
state: Tennessee
city: Amarillo
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Splendora
country: United States
state: Texas
city: Charlottesville
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Roanoke
country: United States
state: Virginia
city: Pleven
country: Bulgaria
city: Plovdiv
country: Bulgaria
city: Ruse
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Sofia
country: Bulgaria
city: Vratsa
country: Bulgaria
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Budapest
country: Hungary
city: Cegléd
country: Hungary
city: Debrecen
country: Hungary
city: Gyor
country: Hungary
city: Gyula
country: Hungary
city: Mosdós
country: Hungary
city: Nagykanizsa
country: Hungary
city: Nyiregyhaza
country: Hungary
city: Szeged
country: Hungary
city: Szekesfehervar
country: Hungary
city: Torokbalint
country: Hungary
city: Veszprém
country: Hungary
city: Caloocan City
country: Philippines
city: Cebu City
country: Philippines
city: Davao City
country: Philippines
city: Iloilo
country: Philippines
city: Manila
country: Philippines
city: Muntinlupa
country: Philippines
city: Quezon City
country: Philippines
city: Quezon City
country: Philippines
city: Esplugues de Llobregat
country: Spain
state: Barcelona
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: London
country: United Kingdom
city: London
country: United Kingdom
Study officials:
affiliation: Duke Clinical Research Institute
name: Michael Cohen-Wolkowiez, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: