A study to assess the safety and activity of an antibiotic (solithromycin) in approximately 400 children and adolescents with bacterial pneumonia.

Phase 1

• Conditions: Suspected or confirmed Community- Acquired Bacterial Pneumonia (CABP); MedDRA version: 18.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862; MedDRA version: 18.1 Level: LLT Classification code 10004051 Term: Bacterial pneumonia, unspecified System Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004039-37-GB
• Lead Sponsor: Cempra Pharmaceuticals, Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-12
• Study Completion: 2018-04-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 97

Inclusion Criteria

1. Written informed consent from parents or other legally acceptable representatives and informed assent from subject (if age appropriate according to local requirements)
2. =2 months to 17 years of age, inclusive
3. Requiring hospitalization, emergency room, or urgent care visit
4. Presence of CABP based on the following criteria within 72 hours prior to randomization:
• 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)
AND
• 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.
AND
• Presence of at least 2 of the following signs or symptoms:
a. Cough
b. Difficulty breathing
c. Production of purulent sputum
d. Chest pain
e. Grunting
f. Hypotension
g. 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
h. 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
i. Physical exam consistent with pulmonary consolidation
AND
• Presence of at least 1 of the following:
a. Leukocytosis (=12,000 white blood cells [WBC]/mm3)
b. Leukopenia (<5000 WBC/mm3)
c. =10% immature neutrophils (bands) regardless of total peripheral WBC
d. Elevated inflammatory markers (C-reactive protein or procalcitonin)
e. Oxygen saturation <97% on room air

f. Organism consistent with a typical respiratory pathogen identified from a blood culture or
isolated from an appropriate respiratory culture/polymerase chain reaction (sputum in
children old enough to produce an acceptable specimen; sample from the lower
respiratory tract airways, if performed [e.g., bronchoalveolar lavage]; or pleural fluid
culture)
Are the trial subjects under 18? yes
Number of subjects for this age range: 400
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Confirmed or suspected respiratory tract infection attributable to sources other than community acquired bacterial pathogens (e.g., ventilator-associated pneumonia; hospital-acquired pneumonia).
2. Received >48 hours of potentially effective systemic antibacterial therapy for CABP immediately prior to randomization (exception: clinical or microbiological treatment failure or progression of signs or symptoms of CABP as determined by the investigator).
3. Confirmed or suspected bacterial meningitis.
4. Known active pulmonary tuberculosis.
5. Non-infectious causes of pulmonary infiltrates (e.g., cystic fibrosis, chemical pneumonitis from aspiration, hypersensitivity pneumonia).
6. Evidence or history of clinically significant medical condition that may, in the assessment of the investigator, impair study participation or pose a significant safety risk or diminish the subject’s ability to undergo all study procedures and assessments.
7. Hepatic dysfunction evidenced by alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >3 times upper limit of normal (ULN) or direct bilirubin greater than 2 times ULN (If direct bilirubin values are not available in a timeframe consistent with enrolment requirements, total bilirubin must be <2 times ULN).
8. Treatment with the following drugs within 72 hours prior to first dose of study drug or expected to receive these drugs during the treatment phase: drugs that potently inhibit CYP3A4 (nefazodone, fluconazole, ketoconazole, conivaptan, diltiazem, verapamil, aprepitant, imatinib, protease inhibitors, clarithromycin, ciprofloxacin, erythromycin, itraconazole, mibefradil, posaconazole, telithromycin, and voriconazole); CYP3A4 inducers (rifampin, rifabutin, phenytoin, fosphenytoin, carbamazepine, phenobarbital, rufinamide, modafinil, armodafinil, etravirine, efavirenz, nevirapine, rilpivirine, bosentan, troglitazone, pioglitazone, and St. John’s wort). In addition, the following drugs may not be
co-administered with solithromycin in this trial due to the potential for adverse drug-drug interaction: digoxin, colchicine, midazolam, quinidine, ergotamine, dihydroergotamine, cisapride, cyclosporine, sildenafil, astemizole, and alfentanil.
9. Breast-feeding females.
10. Positive pregnancy test in females of childbearing potential.
11. History of anaphylaxis to macrolide antibiotics.
12. Previous participation in this study.
13. Subject has received any investigational drug studied under an Investigational New Drug application in the U.S. or under a Clinical Trial Application in the relevant country outside of the U.S. where the subject is being enrolled, taken within 4 weeks before administration of the first dose of study drug.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified