Trial Outcomes & Findings for Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections (NCT NCT01037192)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

4 participants

Primary outcome timeframe

5 days

Results posted on

2015-08-27

Participant Flow

Subjects were recruited from March to September 2010 from patients from the Outpatient Antibiotic Intravenous Therapy clinic at the Royal Columbian Hospital, New Westminster, BC, Canada.

Subjects were excluded from the trial based on the inclusion and exclusion criteria. The main reasons for exclusion include age and weight.

Participant milestones

Participant milestones
Measure	Vancomycin Once Daily Subject receives vancomycin 30 mg/kg dose	Vancomycin Twice Daily Subject receives vancomycin 15 mg/kg twice daily
Overall Study STARTED	3	1
Overall Study COMPLETED	3	1
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Vancomycin Once Daily n=3 Participants Subject receives vancomycin 30 mg/kg dose	Vancomycin Twice Daily n=1 Participants Subject receives vancomycin 15 mg/kg twice daily	Total n=4 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	48 years STANDARD_DEVIATION 12 • n=5 Participants	49 years n=7 Participants	48 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment Canada	3 participants n=5 Participants	1 participants n=7 Participants	4 participants n=5 Participants

PRIMARY outcome

Timeframe: 5 days

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.

Outcome measures

Outcome measures
Measure	Vancomycin Once Daily n=3 subjects Vancomycin 30 mg/kg IV daily	Vancomycin Twice Daily n=1 subjects Vancomycin 15 mg/kg IV twice daily
Clinical Efficacy	2 participants	0 participants

SECONDARY outcome

Timeframe: 5 days

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.

Outcome measures

Outcome measures
Measure	Vancomycin Once Daily n=3 Participants Vancomycin 30 mg/kg IV daily	Vancomycin Twice Daily n=1 Participants Vancomycin 15 mg/kg IV twice daily
Microbiological Efficacy Favourable	0 participants	0 participants
Microbiological Efficacy Unfavourable	1 participants	0 participants
Microbiological Efficacy Indeterminate	2 participants	1 participants

Adverse Events

Vancomycin Once Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vancomycin Twice Daily

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anna Yuen, BSc. Pharm

Fraser Health Authority

Phone: 604-520-4005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place