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]

NCT00198601 Phase 4 COMPLETED

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

Details

Lead sponsor	Johns Hopkins Bloomberg School of Public Health
Phase	Phase 4
Status	COMPLETED
Start date	2003-08
Completion	2005-07

Conditions

• Infection

Interventions

• Gentamicin in Uniject Pre-filled syringe

Primary outcomes

• 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

Countries

Bangladesh, India, Pakistan