Determination of Gentamicin Dosing in Neonatal Patients

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]

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198601

Enrollment

Unknown

Registered

2005-09-20

Start date

2003-08-31

Completion date

2005-07-31

Last updated

2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

meningitis, neonatal deaths, gentamicin, Uniject, aminoglycoside

Brief summary

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

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.

Interventions

DRUGGentamicin in Uniject Pre-filled syringe

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Minutes to 28 Days

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Patients 2.5-3.0 kg	—
High trough>2.0:2/14 patients	—
High peak>12.0: 2/14 patients	—
Low peak <4.0: none	—

Countries

Bangladesh, India, Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026