Determination of Gentamicin Dosing in Neonatal Patients

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2005 by Johns Hopkins Bloomberg School of Public Health. Recruitment status was Active, not recruiting

First Received on 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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
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

ClinicalTrials.gov Identifier:	NCT00198601 History of Changes
Other Study ID Numbers:	H.22.02.08.30.B1
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
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:

Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses

Pharmacologic Actions
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012