Determination of Gentamicin Dosing in Neonatal Patients

Phase 4CompletedNCT00198601

Johns Hopkins Bloomberg School of Public Health

Overview

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

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

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Infection

Interventions

Gentamicin in Uniject Pre-filled syringeDRUG

Eligibility

Sex: ALLMin age: 1 MinuteMax age: 28 Days

Medical Language ↔ Plain English

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

Locations (3)

Dhaka Shishu Hospital

Dhaka, Bangladesh

Neonatal Intensive Care Unit - Christian Vellore Medical

Vellore, India

Aga Khan

Karachi, Pakistan

Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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