Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections

Skin and Soft Tissue Infections Clinical Trial

— VOD  

Official title:

Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01037192
• Other study ID #: VOD
• Status: Completed
• Phase: N/A
• First received: December 18, 2009
• Last updated: August 18, 2015
• Start date: March 2010
• Est. completion date: September 2010

Study information

• Verified date: August 2015
• Source: Fraser Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 19 to 70 years

• Weight 40 - 80 kg

• Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated

• Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician

• Subject able to provide informed consent

Exclusion Criteria:

• Known history of allergy to vancomycin

• Pregnancy

• Granulocytopenia (< 1x109/L)

• Renal impairment (serum creatinine > 177 µmol/L or eGFR < 50 mL/min)

• Known history of vestibular disease or hearing loss

• Subjects treated with vancomycin within the previous month

• Subjects who have received more than 24 hours of vancomycin

• Subjects receiving other antimicrobials that cover MRSA (e.g. cotrimoxazole, rifampin, linezolid)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Skin and Soft Tissue Infections
• Soft Tissue Infections

Intervention

Drug:
• vancomycin
vancomycin 30 mg/kg intravenous administered once daily
• vancomycin
vancomycin 15 mg/kg intravenous administered twice daily (standard dosing)

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital	New Westminster	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Cohen E, Dadashev A, Drucker M, Samra Z, Rubinstein E, Garty M. Once-daily versus twice-daily intravenous administration of vancomycin for infections in hospitalized patients. J Antimicrob Chemother. 2002 Jan;49(1):155-60. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Efficacy	Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (> 15%) in leukocytes.	5 days	No
Secondary	Microbiological Efficacy	Microbiological efficacy is defined as favourable if a repeat culture is negative, if no more materail was obtainable for culture, or if a new microorganism is cultured without clinical signs of infection. It is defined as unfavourable when repeat cultures are positive for the same microorganism, when a new microorganism is cultured with clinical signs of infection or when vancomycin resistance develops. It is defined as indeterminate when the patient is treated with another antibiotic to which the microorganism is susceptible or when no microorganism was cultured at the start of therapy.	5 days	No