This trial is active, not recruiting.

Condition infection
Treatment gentamicin in uniject pre-filled syringe
Phase phase 4
Sponsor Johns Hopkins Bloomberg School of Public Health
Start date August 2003
End date July 2005
Trial identifier NCT00198601, H.


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Patients 2.0-2.24 kg high peak>12.0: 2/6 patients
time frame:
Low peak<4.0: none
time frame:
High trough > 2.0: 1/6 patients
time frame:

Secondary Outcomes

Patients 2.5-3.0 kg
time frame:
High peak>12.0: 2/14 patients
time frame:
Low peak <4.0: none
time frame:
High trough>2.0:2/14 patients
time frame:

Eligibility Criteria

Male or female participants up to 28 days old.

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

Additional Information

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]
Principal investigator Gary Darmstadt, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Johns Hopkins Bloomberg School of Public Health.