Determination of Gentamicin Dosing in Neonatal Patients

This study is ongoing, but not recruiting participants.

First Received: September 12, 2005 No Changes Posted

Sponsor:	Johns Hopkins Bloomberg School of Public Health
Information provided by:	Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00198601

Purpose

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

Condition	Intervention	Phase
Infection	Drug: Gentamicin in Uniject Pre-filled syringe	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Safety/Efficacy Study
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]

Resource links provided by NLM:

Drug Information available for: Gentamicins

U.S. FDA Resources

Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:

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:

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

Study Start Date:	August 2003
Estimated Study Completion Date:	July 2005

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.

Eligibility

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00198601

Locations

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

Sponsors and Collaborators

Johns Hopkins Bloomberg School of Public Health

Investigators

Principal Investigator:

Gary Darmstadt, MD

Johns Hopkins Bloomberg School of Public Health

More Information

No publications provided

Study ID Numbers:	H.22.02.08.30.B1
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00198601 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Johns Hopkins Bloomberg School of Public Health:

meningitis
neonatal deaths
gentamicin
Uniject
aminoglycoside

Additional relevant MeSH terms:

Protein Synthesis Inhibitors
Anti-Infective Agents
Anti-Bacterial Agents
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses

Gentamicins
Enzyme Inhibitors
Infection
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 27, 2009