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Determination of Gentamicin Dosing in Neonatal Patients

Johns Hopkins Bloomberg School of Public Health logo

Johns Hopkins Bloomberg School of Public Health

Status and phase

Completed
Phase 4

Conditions

Infection

Treatments

Drug: Gentamicin in Uniject Pre-filled syringe

Study type

Interventional

Funder types

Other

Identifiers

NCT00198601
H.22.02.08.30.B1

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

1 minute to 28 days old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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