Open-label, Multiple-dose, Phase III Study of the Population Pharmacokinetics of I.V. Synercid in 75 Pediatric Patients

Pfizer

Status and phase: Terminated; Phase 3

Conditions: Gram-Positive Bacterial Infections

Treatments: Drug: Synercid

Study type: Interventional

Funder types: Industry

Identifiers

NCT00240747

RP59500V-324

Details and patient eligibility

About

Open-label, multicenter, multiple-dose, study of population pharmacokinetics of I.V. Synercid (7.5 mg/kg every 8 hours) in 75 pediatric patients. The purpose is to assess the population pharmacokinetics of Synercid in pediatric patients and to collect additional safety and efficacy data in pediatric patients.

Sex: All

Ages: 27 weeks to 16 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Serious, suspected or documented gram-positive infection

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)