CClinicalTrials.gg
Sign In
Status unknownNCT01600768Updated May 17, 2012

Evaluation of Extended Intravenous of Beta-lactams in the Treatment of Serious Gram-negative Infections in Critically Ill Patients

An interventional study of Beta-Lactams and Beta-Lactams in Gram-Negative Bacterial Infections, sponsored by National Taiwan University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-05-17.

Sponsored by National Taiwan University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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).

02

Conditions studied

  • Gram-Negative Bacterial Infections

Keywords

  • focus of study
03

In context

Infections

6,687 studies on the registry are indexed under Infections; 807 are open to participants now.

This study's planned enrollment of 100 is below the median of 120 across 4,200 interventional studies indexed under Infections.

Browse Infections studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,563 studies on the registry; 569 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • renal insufficiency (estimated clearance \< 20 ML /MIN)
  • renal replacement therapy
  • ANC \< 1000 103 µl
  • pregnancy
  • drug abuse
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    intermittent infusion

    Drug: Beta-Lactams

  • Experimental
    extended infusion

    Drug: Beta-Lactams

Interventions

  • DrugBeta-Lactams

    infusion time: 30 mins or 1 hr

  • DrugBeta-Lactams

    infusion time 4 hrs

06

What researchers measure

Primary outcomes

  1. serum concentrations of beta-lactams

    Determination of serum concentrations of beta-lactams

    Time frame: 6 hours

07

Study locations

1 of 1 sites recruiting
  • NTUH
    Taipei City, 100, Taiwan
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01600768
Lead sponsor
National Taiwan University Hospital
Responsible party
Sponsor
First posted
May 17, 2012
Start date
Feb 2012
Primary completion
Dec 2015 (estimated)
Completion
Dec 2015 (estimated)
Last update
May 17, 2012

Study contacts

Shu-Wen Lin, Pharm D.
Contact
shuwenlin@ntu.edu.tw
(02)2312-3456 ext. 88372
Shu-Wen Lin, Pharm D.
principal investigator · National Taiwan University Hospital
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2012. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Infections→

Other studies from this sponsor

National Taiwan University Hospital

Start the discussion