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Completed Phase 1 Interventional

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

ClinicalTrials.gov ID: NCT01019395

Public ClinicalTrials.gov record NCT01019395. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Jul 22, 2026, 8:36 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

An Evaluation of the Pharmacokinetic Profile and Safety of a Single Dose of Daptomycin in Pediatric Subjects Aged 3 Months to Twenty-Four Months Who Are Concurrently Receiving Standard Antibiotic Therapy for Proven or Suspected Bacterial Infection Including Peri-Operative Prophylactic Use of Antibiotics

Study identification

NCT ID
NCT01019395
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Industry
Enrollment
23 participants

Conditions and interventions

Interventions

  • Daptomycin Drug

Drug

Eligibility (public fields only)

Age range
3 Months to 24 Months
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jan 4, 2010
Primary completion
Mar 19, 2012
Completion
Mar 19, 2012
Last update posted
Nov 12, 2019

2010 – 2012

United States locations

U.S. sites
8
U.S. states
6
U.S. cities
8
Facility City State ZIP Site status
Arkansas Children's Hospital Little Rock Arkansas 72202
Children's Hospital of Orange County Orange California 92868
Rady Children's Hospital-San Diego San Diego California 92123
University of Louisiana at Monroe Shreveport Louisiana 71103
Children's Mercy Hospital and Clinics Kansas City Missouri 64108
University Hospitals Case Medical Center Cleveland Ohio 44106
Toledo Children's Hospital Toledo Ohio 43606
Cook Children's Medical Center Fort Worth Texas 76104

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01019395, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Nov 12, 2019 · Synced Jul 22, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01019395 live on ClinicalTrials.gov.

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