Determination of Gentamicin Dosing in Neonatal Patients

Condition(s) targeted: Infection

Intervention: Gentamicin in Uniject Pre-filled syringe (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Johns Hopkins Bloomberg School of Public Health

Official(s) and/or principal investigator(s):
Gary Darmstadt, MD, Principal Investigator, Affiliation: Johns Hopkins Bloomberg School of Public Health

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

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]

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

Primary outcome:

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:

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

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.

Minimum age: N/A. Maximum age: 28 Days. Gender(s): Both.

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

Dhaka Shishu Hospital, Dhaka, Bangladesh

Neonatal Intensive Care Unit - Christian Vellore Medical, Vellore, India

Aga Khan, Karachi, Pakistan

Starting date: August 2003
Ending date: July 2005
Last updated: September 12, 2005