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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01600768
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 46
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Gram-Negative Bacterial Infections	Drug: Beta-Lactams; Drug: Beta-Lactams	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Feb 1, 2012
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: intermittent infusion	Drug: Beta-Lactams; infusion time: 30 mins or 1 hr
Experimental: extended infusion	Drug: Beta-Lactams; infusion time 4 hrs

Outcome Measures

Primary Outcome Measures

1. serum concentrations of beta-lactams [6 hours]

   Determination of serum concentrations of beta-lactams

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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:

• renal insufficiency (estimated clearance < 20 ML /MIN)

• renal replacement therapy

• ANC < 1000 103 µl

• pregnancy

• drug abuse

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NTUH	Taipei City		Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

• Principal Investigator: Shu-Wen Lin, Pharm D., National Taiwan University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT01600768
• Other Study ID Numbers: 200912104M
• First Posted: May 17, 2012
• Last Update Posted: May 17, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by National Taiwan University Hospital: focus of study
• Additional relevant MeSH terms: Infections; Bacterial Infections; Gram-Negative Bacterial Infections; Lactams; beta-Lactams

Study Results

No Results Posted as of May 17, 2012