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NCT01019395 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study of Gram Positive Bacterial Infection, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- Completed
- Registry status
- Phase 1
- Development phase
- 23
- Enrollment target
- 8
- Study locations
NCT01019395 is a Phase 1 study of Gram Positive Bacterial Infection that has completed, run by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA). The registered enrollment target is 23 participants. The trial reports 8 study locations across 6 states.
The verdict
NCT01019395, a Phase 1 study of Gram Positive Bacterial Infection, has completed, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 23 participants
- Enrollment target
- 8
- Study locations
Study 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 .
Conditions Studied
Interventions
- DRUG Daptomycin
Study Locations (8)
California
- Children's Hospital of Orange County - Orange
- Rady Children's Hospital-San Diego - San Diego
Ohio
- University Hospitals Case Medical Center - Cleveland
- Toledo Children's Hospital - Toledo
Arkansas
- Arkansas Children's Hospital - Little Rock
Louisiana
- University of Louisiana at Monroe - Shreveport
Missouri
- Children's Mercy Hospital and Clinics - Kansas City
Texas
- Cook Children's Medical Center - Fort Worth
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2010-01-05 |
| Est. Completion | 2012-03-20 |
| Phase | Phase 1 |
Sponsor
Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)42 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01019395
The ClinicalTrials.gov registry entry for NCT01019395 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Gram Positive Bacterial Infection appearing as the primary indexed condition, and to 1 intervention - of which Daptomycin is the first listed.
NCT01019395 reports 8 study locations spanning 6 distinct geographic areas - top geographies include California, Ohio, Arkansas.
Frequently Asked Questions
What is clinical trial NCT01019395 about?
NCT01019395 is a clinical study titled "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". 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-positiv...
What is the current status of trial NCT01019395?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2010-01-05. Estimated completion is 2012-03-20.
What conditions does trial NCT01019395 study?
This clinical trial studies the following conditions: Gram Positive Bacterial Infection.
What interventions are being tested in trial NCT01019395?
The interventions under investigation include: Daptomycin (DRUG).
Who is sponsoring clinical trial NCT01019395?
This trial is sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA), which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01019395 being conducted?
This trial has 8 study locations across Arkansas, California, Louisiana, Missouri, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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