Trial Outcomes & Findings for Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis (NCT NCT00967941)

NCT ID: NCT00967941

Last Updated: 2020-02-28

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 169 participants
• Primary outcome timeframe: 30 days post-operative
• Results posted on: 2020-02-28

Participant Flow

recruitment was done during the period August 2007 through June 2009 at vascular center.

12 patients were excluded from study for being ineligible due to active infection, dialysis, allergy to penicillin,NO procedure, withdrew from surgery.

Participant milestones

Measure	Ancef Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Daptomycin and Cefazolin Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Vancomycin and Cefazolin Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
Overall Study STARTED	67	54	60
Overall Study COMPLETED	62	51	56
Overall Study NOT COMPLETED	5	3	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vancomycin and Daptomycin Plus Cefazolin for Preoperative Vascular Surgery Prophylaxis

Baseline characteristics by cohort

Measure	Ancef n=67 Participants Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Daptomycin and Cefazolin n=54 Participants Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Vancomycin and Cefazolin n=60 Participants Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Total n=181 Participants Total of all reporting groups
Age, Continuous	64.37 years STANDARD_DEVIATION 11.78 • n=93 Participants	66.78 years STANDARD_DEVIATION 11.81 • n=4 Participants	64.36 years STANDARD_DEVIATION 11.12 • n=27 Participants	65.17 years STANDARD_DEVIATION 11.57 • n=483 Participants
Sex: Female, Male Female	26 Participants n=93 Participants	20 Participants n=4 Participants	20 Participants n=27 Participants	66 Participants n=483 Participants
Sex: Female, Male Male	41 Participants n=93 Participants	34 Participants n=4 Participants	40 Participants n=27 Participants	115 Participants n=483 Participants

PRIMARY outcome

Timeframe: 30 days post-operative

Population: Patients with MRSA infections.

Outcome measures

Measure	Ancef n=62 Participants Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Daptomycin and Cefazolin n=51 Participants Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Vancomycin and Cefazolin n=56 Participants Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
Overall Number of Participants With Methicillin-resistant Staphylococcus Aureus (MRSA) Infections.	2 participants	0 participants	4 participants

SECONDARY outcome

Timeframe: 30 days post-operative

Population: Patients with groin procedures.

Outcome measures

Measure	Ancef n=17 Participants Ancef (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Daptomycin and Cefazolin n=152 Participants Daptomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery	Vancomycin and Cefazolin Vancomycin and Cefazolin (Antibiotic Prophylaxis) : Comparing the antibiotic treatment related to surgery
Overall Groin Procedures in Patients With and Without Any Infection.	14 Participants	83 Participants	—

Adverse Events

All Patients

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

Patrick Stone, MD

CAMC Health System

Phone: 304-388-8250

Email: pstone0627@yahoo.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place