Determination of Gentamicin Dosing in Neonatal Patients - Tabular View

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

September 12, 2005

Start Date ^ICMJE

August 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Patients 2.0-2.24 kg high peak>12.0: 2/6 patients
Low peak<4.0: none
High trough > 2.0: 1/6 patients

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Patients 2.5-3.0 kg
High peak>12.0: 2/14 patients
Low peak <4.0: none
High trough>2.0:2/14 patients

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Determination of Gentamicin Dosing in Neonatal Patients

Official Title ^ICMJE

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]

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 Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Infection

Intervention ^ICMJE

Drug: Gentamicin in Uniject Pre-filled syringe

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

Completion Date

July 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

infants with culture proven sepsis
infants 2000-2499 at birth
infants > 2500 gm at birth
infants < 2000 gm at birth
in study site areas: Pakistan, Bangladesh and India

Exclusion Criteria:

infants w/o culture proven sepsis

Gender

Both

Ages

up to 28 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Bangladesh, India, Pakistan

Administrative Information

NCT ID ^ICMJE

NCT00198601

Responsible Party

Study ID Numbers ^ICMJE

H.22.02.08.30.B1

Study Sponsor ^ICMJE

Johns Hopkins Bloomberg School of Public Health

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Gary Darmstadt, MD

Johns Hopkins Bloomberg School of Public Health

Information Provided By

Johns Hopkins Bloomberg School of Public Health

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP