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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

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 20, 2005
Last Update Posted Date April 20, 2018
Study Start Date  ICMJE August 2003
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Determination of Gentamicin Dosing in Neonatal Patients
Official Title  ICMJE 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]
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Infection
Intervention  ICMJE Drug: Gentamicin in Uniject Pre-filled syringe
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2005
Actual Primary Completion Date July 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 28 Days   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bangladesh,   India,   Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00198601
Other Study ID Numbers  ICMJE H.22.02.08.30.B1
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Johns Hopkins Bloomberg School of Public Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gary Darmstadt, MD Johns Hopkins Bloomberg School of Public Health
PRS Account Johns Hopkins Bloomberg School of Public Health
Verification Date September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP