NCT00198601

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2003

Geographic Reach
3 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

April 20, 2018

Status Verified

September 1, 2005

Enrollment Period

1.9 years

First QC Date

September 12, 2005

Last Update Submit

April 18, 2018

Conditions

Infection

Keywords

meningitisneonatal deathsgentamicinUnijectaminoglycoside

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Patients 2.5-3.0 kg

  • High peak>12.0: 2/14 patients

  • Low peak <4.0: none

  • High trough>2.0:2/14 patients

Interventions

Gentamicin in Uniject Pre-filled syringeDRUG

Eligibility Criteria

Age1 Minute - 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • infants w/o culture proven sepsis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dhaka Shishu Hospital

Dhaka, Bangladesh

Location

Neonatal Intensive Care Unit - Christian Vellore Medical

Vellore, India

Location

Aga Khan

Karachi, Pakistan

Location

MeSH Terms

Conditions

InfectionsMeningitisPerinatal Death

Interventions

Gentamicins

Condition Hierarchy (Ancestors)

Neuroinflammatory DiseasesNervous System DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminoglycosidesGlycosidesCarbohydrates

Study Officials

  • Gary Darmstadt, MD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2003

Primary Completion

July 1, 2005

Study Completion

July 1, 2005

Last Updated

April 20, 2018

Record last verified: 2005-09

Locations

BA(1)IN(1)PA(1)