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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: Completed Phase 1 study of Gram Positive Bacterial Infection, sponsored by Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower). The trial reports 8 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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
What the finished NCT01019395 record still lists
NCT01019395 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 23 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (62% lower).
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 lists 8 locations in 6 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01019395's enrollment target sits among peer trials
23 1596th of 2000 higher than 400 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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