Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00198601
Status:
COMPLETED
Last Update Posted:
2018-04-20
First Post:
2005-09-12
Brief Title:
Determination of Gentamicin Dosing in Neonatal Patients
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Determination of Gentamicin Dosing in Neonatal Patients for Use in the Uniject Pre-filled Syringe A Three-site Study at 1 Dhaka Shishu Hospital Dhaka Bangladesh 2 Christain Medical Center Vellore India and 3 Aga Khan University Medical Center Karachi Pakistan
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device Uniject is appropriate
Detailed Description:
This study aims to verify dosages of gentamicin for use in Uniject chosen based on a consideration of gentamicin pharmacokinetics safety efficacy target population body weight cost feasibility and acceptability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None