InfectionPhase 4NCT00198601
Determination of Gentamicin Dosing in Neonatal Patients
A Phase 4 study testing Gentamicin in Uniject Pre-filled syringe in people with Infection, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in 3 countries.
Trial summary
The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate. Read more about this study
- Who is it for?
- Ages 1 minute to 28 days
- Conditions the study is for
- Infection
- What is being tested?
- Gentamicin in Uniject Pre-filled syringe
- Type of treatment
- Injection or infusion
- How many people
- Not given
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2003to Jul 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- infants w/o culture proven sepsis
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
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]
The purpose of this study is to determine what dosage of gentamicin for use in one-time administration device (Uniject) is appropriate.
Read the 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.
- Conditions
- Infection
- Being tested
- Gentamicin in Uniject Pre-filled syringe
- Keywords
- meningitis, neonatal deaths, gentamicin, Uniject, aminoglycoside
- Medical subject headings
- Infections, Meningitis, Perinatal Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gentamicin in Uniject Pre-filled syringeDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startAug 2003
- Primary completionJul 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Investigators
- Gary Darmstadt, MD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00198601
- Sponsor's protocol ID
- H.22.02.08.30.B1
- Status last verified
- Sep 2005
- First submitted
- 12 Sep 2005
- Last updated
- 20 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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]
- ClinicalTrials.gov ID
- NCT00198601
- Acronym / sponsor ID
- H.22.02.08.30.B1
- Conditions
- Infection
- Keywords
- meningitis, neonatal deaths, gentamicin, Uniject, aminoglycoside
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 20 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 minute to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- infants w/o culture proven sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gentamicin in Uniject Pre-filled syringe | Drug | – |
Primary outcome
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
4 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Darmstadt, MD principal investigator
Johns Hopkins Bloomberg School of Public Health
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gentamicin in Uniject Pre-filled syringe in people with Infection, run by Johns Hopkins Bloomberg School of Public Health at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Bangladesh, India, Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients 2.0-2.24 kg high peak>12.0: 2/6 patients. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.