Pharmacokinetics and Safety of Solithromycin Capsules in paediatric subjects.

• Conditions: suspected or confirm bacterial infection; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2014-004041-26-Outside-EU/EEA
• Lead Sponsor: Cempra Pharmaceuticals , Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-10
• Last Update Posted: 27 October 2014

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

1. <18 years of age
2. Suspected or confirmed bacterial infection with organisms against which solithromycin is expected to be active

Are the trial subjects under 18? yes
Number of subjects for this age range: 64
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. Serum creatinine >2 mg/dL
2. Hepatic dysfunction – ALT or AST >3x ULN or direct bilirubin >ULN

Study & Design

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