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Determination of Gentamicin Dosing in Neonatal Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00198601
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : April 20, 2018
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Infection Drug: Gentamicin in Uniject Pre-filled syringe Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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]
Study Start Date : August 2003
Actual Primary Completion Date : July 2005
Actual Study Completion Date : July 2005

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Patients 2.0-2.24 kg high peak>12.0: 2/6 patients
  2. Low peak<4.0: none
  3. High trough > 2.0: 1/6 patients

Secondary Outcome Measures :
  1. Patients 2.5-3.0 kg
  2. High peak>12.0: 2/14 patients
  3. Low peak <4.0: none
  4. High trough>2.0:2/14 patients


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00198601


Locations
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Bangladesh
Dhaka Shishu Hospital
Dhaka, Bangladesh
India
Neonatal Intensive Care Unit - Christian Vellore Medical
Vellore, India
Pakistan
Aga Khan
Karachi, Pakistan
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Investigators
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Principal Investigator: Gary Darmstadt, MD Johns Hopkins Bloomberg School of Public Health

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ClinicalTrials.gov Identifier: NCT00198601    
Other Study ID Numbers: H.22.02.08.30.B1
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: September 2005
Keywords provided by Johns Hopkins Bloomberg School of Public Health:
meningitis
neonatal deaths
gentamicin
Uniject
aminoglycoside
Additional relevant MeSH terms:
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Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action