Determination of Gentamicin Dosing in Neonatal Patients

NCT ID: NCT00198601

Last Updated: 2018-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Infection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Gentamicin in Uniject Pre-filled syringe

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

1 Minute

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role lead

Principal Investigators

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Gary Darmstadt, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health

Locations

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Dhaka Shishu Hospital

Dhaka, , Bangladesh

Site Status

Neonatal Intensive Care Unit - Christian Vellore Medical

Vellore, , India

Site Status

Aga Khan

Karachi, , Pakistan

Site Status

Countries

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Bangladesh India Pakistan

Other Identifiers

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H.22.02.08.30.B1

Identifier Type: -

Identifier Source: org_study_id

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