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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 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.

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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

Conditions Studied

Pneumonia

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

FieldValue
Enrollment Target 30 participants
Start Date 2007-03
Est. Completion 2007-08
Phase Phase 2

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT01021436

The ClinicalTrials.gov registry entry for NCT01021436 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,519-participant average among 47 other Pneumonia trials with a reported enrollment target (99% lower). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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 reports 6 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.