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



Status:Terminated
Conditions:Pneumonia
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 17
Updated:1/5/2019
Start Date:April 2016
End Date:March 21, 2018

Use our guide to learn which trials are right for you!

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

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).

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.

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
We found this trial at
22
sites
?
mi
from
Splendora, TX
Click here to add this to my saved trials
?
mi
from
Amarillo, TX
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Durham, NC
Click here to add this to my saved trials
Greenville, North Carolina 27834
?
mi
from
Greenville, NC
Click here to add this to my saved trials
?
mi
from
Hershey, PA
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Omaha, NE
Click here to add this to my saved trials
?
mi
from
Pleven,
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Roanoke, VA
Click here to add this to my saved trials
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
?
mi
from
Toledo, OH
Click here to add this to my saved trials
?
mi
from
Washington,
Click here to add this to my saved trials