Determination of Gentamicin Dosing in Neonatal Patients

April 18, 2018 updated by: Johns Hopkins Bloomberg School of Public Health

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]

The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • Dhaka Shishu Hospital
  • India
      • Vellore, India
        • Neonatal Intensive Care Unit - Christian Vellore Medical
  • Pakistan
      • Karachi, Pakistan
        • Aga Khan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 4 weeks (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins Bloomberg School of Public Health

Investigators

  • Principal Investigator: Gary Darmstadt, MD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

July 1, 2005

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 18, 2018

Last Verified

September 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H.22.02.08.30.B1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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