NCT01600768

Brief Summary

The purpose of this study is to evaluate the PK/PD parameters, safety and efficacy of extended infusion of beta-lactams in intensive care patients who are infected with Gram-negative bacteremia or pneumonia at National Taiwan University Hospital (NTUH).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 16, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

May 17, 2012

Status Verified

February 1, 2012

Enrollment Period

3.8 years

First QC Date

May 16, 2012

Last Update Submit

May 16, 2012

Conditions

Gram-Negative Bacterial Infections

Keywords

focus of study

Outcome Measures

Primary Outcomes (1)

  • serum concentrations of beta-lactams

    Determination of serum concentrations of beta-lactams

    6 hours

Study Arms (2)

intermittent infusion

ACTIVE COMPARATOR
Drug: Beta-Lactams

extended infusion

EXPERIMENTAL
Drug: Beta-Lactams

Interventions

Beta-LactamsDRUG

infusion time: 30 mins or 1 hr

intermittent infusion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (\> 18 years)
  • Admitted on the intensive care unit
  • Starting a treatment with beta-lactams antibiotics
  • Signed informed consent
  • Expected to live \> 3 days

You may not qualify if:

  • renal insufficiency (estimated clearance \< 20 ML /MIN)
  • renal replacement therapy
  • ANC \< 1000 103 µl
  • pregnancy
  • drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, 100, Taiwan

RECRUITING

MeSH Terms

Conditions

Gram-Negative Bacterial Infections

Interventions

beta-Lactams

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

LactamsAmidesOrganic ChemicalsSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Shu-Wen Lin, Pharm D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shu-Wen Lin, Pharm D.

CONTACT

(02)2312-3456shuwenlin@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2012

First Posted

May 17, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

May 17, 2012

Record last verified: 2012-02

Locations

TW(1)