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Activity and safety of solithromycin in paediatric patients with pneumonia.

A Phase 2/3, Randomised, Partly blinded (blinded investigator), Multi-center, Comparative Study to Determine the Safety and activity of Solithromycin (Intravenous and oral) in paediatric patients with suspected or confirmed community acquire bacterial pnaumonia (CABP).

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2014-004039-37-Outside-EU/EEA
Enrollment
300
Registered
2014-10-10
Start date
Unknown
Completion date
Unknown
Last updated
2014-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

suspected or confirmed community acquired bacterial pneuumonia (CABP)

Interventions

Product Name: solithromycin Product Code: CEM-101 Pharmaceutical Form: Capsule INN or Proposed INN: solithromycin Other descriptive name: SOLITHROMYCIN Concentration unit: mg milligram(s) Concentratio

Sponsors

Cempra Pharmaceuticals, Inc.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patient is >2 months to 17 years (inclusive) of age 2. Patient requires 2 days of initial hospitalization with a minimum total of 5 days of antibiotic therapy, but no more than 14 days total of study therapy (IV and PO combined) 3. Presence of CABP based on the following criteria: 3.1 Fever (temperature >38.0°C) or hypothermia (temperature 15,000 white blood cells [WBC]/mm3) o >15% immature neutrophils (bands) regardless of total peripheral WBC o Leukopenia (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Serum creatinine >2 mg/dL 2. Hepatic dysfunction – ALT or AST >3x ULN or direct bilirubin >ULN

Design outcomes

Primary

MeasureTime frame
Main Objective: Determine the safety and tolerability of solithromycin;Secondary Objective: Activity of solithromycin (clinical and microbiological responses) Population pharmacokinetics;Primary end point(s): Proportion of children with AEs or therapy not tolerated.;Timepoint(s) of evaluation of this end point: end of study—

Secondary

MeasureTime frame
Secondary end point(s): Clinical response Microbiological response Population Pharmacokinetic ;Timepoint(s) of evaluation of this end point: At Test of Cure, i.e. 5-10 days after the end of treatment, for clinical response Microbiological response for each baseline pathogen—

Countries

United States

Contacts

Public ContactClinical Trials Info

Cempra Pharmaceuticals, Inc.

Clinicaltrials@cempra.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026