drugset / Trial / NCT01019395

Pharmacokinetics (PK) and Safety Evaluation of Daptomycin in Children Ages 3-24 Months With Proven or Suspected Gram-positive Infections or Peri-Operative Subjects Receiving Prophylactic Antibiotics

NCT01019395

Phase 1 Completed 23 enrolled Merck & Co., Inc.
Non-randomizedSingle-groupOpen-labelBasic science

Summary

This is a research study designed to look at the pharmacokinetics (distribution, breakdown, and removal) and tolerability of a single dose of daptomycin in patients aged 3 months to 24 months who have proven or suspected infections that are caused by a specific group of bacteria (called Gram-positive bacteria)or perioperative subjects that are receiving prophylactic antibiotics .

Timeline

Start
2010-01-05
Primary completion
2012-03-20
Completion
2012-03-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Daptomycin Other / unclassified 4 mg/kg Intravenous
Subject Daptomycin Other / unclassified 6 mg/kg Intravenous