Determination of Gentamicin Dosing in Neonatal Patients | NCT00198601

Studies
Determination of Gentamicin Dosing in Neonatal Patients

NCT00198601

Sponsor

Johns Hopkins Bloomberg School of Public Health

Status

Completed

Last Update Posted

Apr 20, 2018Actual

Enrollment

Not provided

Phase

Phase 4

Conditions

Infection

Interventions

Gentamicin in Uniject Pre-filled syringe

Countries

Bangladesh
India
Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

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]

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Jul 2005Actual

Completion Date

Jul 2005Actual

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2018

Last Update Posted Date

Apr 20, 2018Actual

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Gentamicin in Uniject Pre-filled syringe	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Patients 2.5-3.0 kg
High peak>12.0: 2/14 patients
Low peak <4.0: none

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

28 Days

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gary Darmstadt, MD	Johns Hopkins Bloomberg School of Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dhaka Shishu Hospital		Dhaka			Bangladesh
Neonatal Intensive Care Unit - Christian Vellore Medical

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D008581	Meningitis
D066087	Perinatal Death

Ancestor Terms

ID	Term
D000090862	Neuroinflammatory Diseases
D009422	Nervous System Diseases
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D005839	Gentamicins

Ancestor Terms

ID	Term
D000617	Aminoglycosides
D006027	Glycosides
D002241	Carbohydrates

Browse Leaves

Not provided

Browse Branches

Not provided