Determination of Gentamicin Dosing in Neonatal Patients
Phase 4
Completed
- Conditions
- Infection
- Registration Number
- NCT00198601
- Lead Sponsor
- Johns Hopkins Bloomberg School of Public Health
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method High peak>12.0: 2/14 patients Low peak <4.0: none High trough>2.0:2/14 patients Patients 2.5-3.0 kg
Trial Locations
- Locations (3)
Dhaka Shishu Hospital
🇧🇩Dhaka, Bangladesh
Neonatal Intensive Care Unit - Christian Vellore Medical
🇮🇳Vellore, India
Aga Khan
🇵🇰Karachi, Pakistan