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NCT00198601 Clinical Trial

Determination of Gentamicin Dosing in Neonatal Patients

Infection Clinical Trial

Official title:
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]

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00198601
Other study ID # H.22.02.08.30.B1
Secondary ID
Status Completed
Phase Phase 4
First received September 12, 2005
Last updated April 18, 2018
Start date August 2003
Est. completion date July 2005

Study information
Verified date September 2005
Source Johns Hopkins Bloomberg School of Public Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date July 2005
Est. primary completion date July 2005
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Gentamicin in Uniject Pre-filled syringe

Locations
Country Name City State
Bangladesh Dhaka Shishu Hospital Dhaka
India Neonatal Intensive Care Unit - Christian Vellore Medical Vellore
Pakistan Aga Khan Karachi

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins Bloomberg School of Public Health

Countries where clinical trial is conducted

Bangladesh,  India,  Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patients 2.0-2.24 kg high peak>12.0: 2/6 patients
Primary Low peak<4.0: none
Primary High trough > 2.0: 1/6 patients
Secondary Patients 2.5-3.0 kg
Secondary High peak>12.0: 2/14 patients
Secondary Low peak <4.0: none
Secondary High trough>2.0:2/14 patients
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