Reducing Nephrotoxicity of Vancomycin: A Prospective Study of Continuous Versus Intermittent Infusion of Vancomycin

NCT ID: NCT01720940

Last Updated: 2012-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-09-30

Brief Summary

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This study is being carried out to find out whether there is reduction in vancomycin-induced kidney injury (nephrotoxicity) when vancomycin is given as intermittent versus continuous infusion.

This study will recruit 220 subjects from 2 hospitals over a period of 3 years.

Participants are invited if they have an infection that requires prolonged vancomycin therapy (\> more than 10 days).

Detailed Description

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Conditions

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Infections Requiring Prolonged Duration (>10 Days) of Vancomycin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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continuous vancomycin infusion

Group Type EXPERIMENTAL

continuous vancomycin infusion

Intervention Type DRUG

24-hour continuous infusion of vancomycin

intermittent vancomycin infusion

vancomycin in this arm will be administered as intermittent infusion

Group Type ACTIVE_COMPARATOR

intermittent vancomycin infusion

Intervention Type DRUG

Interventions

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continuous vancomycin infusion

24-hour continuous infusion of vancomycin

Intervention Type DRUG

intermittent vancomycin infusion

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adults aged 21-80 years
* Documented infection requiring prolonged (\> 10 days) of vancomycin therapy
* Creatinine clearance \> 50 ml/min (using Cockroft-Gault equation)

Exclusion Criteria

* Patient already received 7 days or more of vancomycin therapy
* Pregnancy
* Severe burns \> 40% body surface area
* Spinal cord injuries
* Participation in another interventional trial in previous 30 days
* Inability to obtain informed consent
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

National University Hospital, Singapore

OTHER

Sponsor Role lead

Responsible Party

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Medicine

Division of Infectious Diseases

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National University Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Shire Yang Tan

Role: CONTACT

Phone: 97989001

Email: [email protected]

Facility Contacts

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Shire Yang Tan

Role: primary

Other Identifiers

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NUHID-001

Identifier Type: -

Identifier Source: org_study_id