Status:
COMPLETED
Determination of Gentamicin Dosing in Neonatal Patients
Lead Sponsor:
Johns Hopkins Bloomberg School of Public Health
Conditions:
Infection
Eligibility:
All Genders
1-28 years
Phase:
PHASE4
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 a...
Eligibility Criteria
Inclusion
- 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
- infants w/o culture proven sepsis
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00198601
Start Date
August 1 2003
End Date
July 1 2005
Last Update
April 20 2018
Active Locations (3)
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1
Dhaka Shishu Hospital
Dhaka, Bangladesh
2
Neonatal Intensive Care Unit - Christian Vellore Medical
Vellore, India
3
Aga Khan
Karachi, Pakistan