Trials / Completed
CompletedNCT00198601
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
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Johns Hopkins Bloomberg School of Public Health · Academic / Other
- Sex
- All
- Age
- 1 Minute – 28 Days
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gentamicin in Uniject Pre-filled syringe |
Timeline
- Start date
- 2003-08-01
- Primary completion
- 2005-07-01
- Completion
- 2005-07-01
- First posted
- 2005-09-20
- Last updated
- 2018-04-20
Locations
3 sites across 3 countries: Bangladesh, India, Pakistan
Source: ClinicalTrials.gov record NCT00198601. Inclusion in this directory is not an endorsement.