Suspected or confirmed Community- Acquired Bacterial Pneumonia (CABP) MedDRA version: 18.1 Level: LLT Classification code 10004051 Term: Bacterial pneumonia, unspecified System Organ Class: 100000004862 MedDRA version: 18.1 Level: LLT Classification code 10010120 Term: Community acquired pneumonia System Organ Class: 100000004862
Conditions
Interventions
Product Name: Solithromycin
Product Code: CEM-101
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: SOLITHROMYCIN
Sponsors
Cempra Pharmaceuticals, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the safety and tolerability of solithromycin in adolescents and children with Community Acquired Bacterial Pneumonia (CABP) ; Secondary Objective: • Evaluate the efficacy of solithromycin in adolescents and children with CABP • Evaluate the population pharmacokinetics (PK) of solithromycin in adolescents and children with CABP ;Primary end point(s): Primary safety endpoints will be the proportion of subjects experiencing an AE and the proportion of subjects discontinuing study drug due to a related AE.;Timepoint(s) of evaluation of this end point: The primary efficacy endpoint is defined as clinical improvement on the last day of treatment (end of treatment response). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include efficacy of solithromycin or active comparator as evidenced by clinical response and population PK of solithromycin. ;Timepoint(s) of evaluation of this end point: The secondary efficacy endpoints are defined as early clinical response at Days 24 and clinical success (i.e., cure) at the short-term follow-up visit (10 days [+/– 4 days] after the last dose of treatment). | — |
Countries
Brazil, Hungary, Philippines, Spain, United Kingdom
Contacts
Public ContactRegulatory Department
Chiltern International Ltd
Outcome results
None listed