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NCT01021436 · ClinicalTrials.gov registry record · Phase 2
Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia
A Phase 2 study of Pneumonia, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 6
- Study locations
NCT01021436: Completed Phase 2 study of Pneumonia, sponsored by Bayer.
NCT01021436 is a Phase 2 study of Pneumonia that has completed, run by Bayer. The registered enrollment target is 30 participants, below the 4,519-participant average among 47 other Pneumonia trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01021436, a Phase 2 study of Pneumonia, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 6
- Study locations
Study Summary
This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated
Primary Outcome
Maximum serum amikacin concentration observed from time 0 to 12 h
Conditions Studied
Interventions
- DRUG Amikacin inhalation solution (BAY41-6551)
Study Locations (6)
Alabama
- - Birminghan
Ohio
- - Cincinnati
Tennessee
- - Memphis
Texas
- - Houston
Cedex 13
- - Paris
Cedex
- - Limoges
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2007-03 |
| Est. Completion | 2007-08 |
| Phase | Phase 2 |
What the finished NCT01021436 record still lists
NCT01021436 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 4,519-participant average among 47 other Pneumonia trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Pneumonia appearing as the primary indexed condition, and to 1 intervention - of which Amikacin inhalation solution (BAY41-6551) is the first listed.
NCT01021436 lists 6 locations in 6 states (Alabama, Ohio, Tennessee).
Frequently Asked Questions
What is clinical trial NCT01021436 about?
NCT01021436 is a clinical study titled "Safety, Tolerability and Pharmacokinetics of Aerosolized Amikacin in Intubated and Mechanically-ventilated Patients With Nosocomial Pneumonia". This study is to understand how the inhaled form of amikacin is spread throughout the human body and how it is eliminated from the body and to make sure that giving an inhaled form of Amikacin to patients is safe and well tolerated
What is the current status of trial NCT01021436?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2007-03. Estimated completion is 2007-08.
What conditions does trial NCT01021436 study?
This clinical trial studies the following conditions: Pneumonia.
What interventions are being tested in trial NCT01021436?
The interventions under investigation include: Amikacin inhalation solution (BAY41-6551) (DRUG).
Who is sponsoring clinical trial NCT01021436?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01021436 being conducted?
This trial has 6 study locations across Alabama, Ohio, Tennessee, Texas, Cedex 13. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pneumonia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01021436's enrollment target sits among peer trials
30 40th of 47 higher than 6 of 47 other Pneumonia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pneumonia 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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