Determination of Gentamicin Dosing in Neonatal Patients

Johns Hopkins Bloomberg School of Public Health

Status and phase: Completed; Phase 4

Conditions: Infection

Treatments: Drug: Gentamicin in Uniject Pre-filled syringe

Study type: Interventional

Funder types: Other

Identifiers

NCT00198601

H.22.02.08.30.B1

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: 1 minute to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)