Trial Outcomes & Findings for Comparison of Intravenous Cefazolin Plus Oral Probenecid With Oral Cephalexin for the Treatment of Cellulitis (NCT NCT01029782)

NCT ID: NCT01029782

Last Updated: 2018-08-13

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 206 participants
• Primary outcome timeframe: 72 hours
• Results posted on: 2018-08-13

Participant Flow

Patients were included if they presented to the ED with presumed diagnosis of mild-moderate SSTI and were deemed well enough to be treated as outpatients and be able to return to the ED daily.

Participant milestones

Measure	IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.	Oral Cephalexin and Saline IV Plus Probenecid Placebo Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
Overall Study STARTED	102	104
Overall Study COMPLETED	99	96
Overall Study NOT COMPLETED	3	8

Reasons for withdrawal

Measure	IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.	Oral Cephalexin and Saline IV Plus Probenecid Placebo Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
Overall Study Lost to Follow-up	2	2
Overall Study Diagnosis changed	1	1
Overall Study Adverse Event	0	1
Overall Study Physician Decision	0	1
Overall Study Protocol Violation	0	2
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin n=102 Participants IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.	Oral Cephalexin and Saline IV Plus Probenecid Placebo n=101 Participants Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily	Total n=203 Participants Total of all reporting groups
Age, Continuous	55.21 years STANDARD_DEVIATION 17.71 • n=102 Participants	52.01 years STANDARD_DEVIATION 19.64 • n=101 Participants	53.62 years STANDARD_DEVIATION 18.72 • n=203 Participants
Sex: Female, Male Female	36 Participants n=102 Participants	30 Participants n=101 Participants	66 Participants n=203 Participants
Sex: Female, Male Male	66 Participants n=102 Participants	71 Participants n=101 Participants	137 Participants n=203 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	102 participants n=102 Participants	101 participants n=101 Participants	203 participants n=203 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: Per-Protocol Analysis at 72 hours.

Outcome measures

Measure	Oral Cephalexin and Saline IV Plus Probenecid Placebo n=96 Participants Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily	IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin n=99 Participants IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.
The Number of Patients Failing Therapy After 72 Hours of Antibiotic Treatment With Oral Cephalexin or Intravenous Cefazolin Plus Oral Probenecid.	4 Participants	6 Participants

Adverse Events

IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Oral Cephalexin and Saline IV Plus Probenecid Placebo

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	IV Cefazolin Plus Oral Probenecid and Placebo Cephalexin n=102 participants at risk IV cefazolin plus oral probenecid and placebo cephalexin: Intravenous cefazolin 2 g IV plus probenecid 1 g daily plus cephalexin placebo orally four times daily.	Oral Cephalexin and Saline IV Plus Probenecid Placebo n=101 participants at risk Oral cephalexin and saline IV plus probenecid placebo: Cephalexin 500 mg orally four times daily plus saline IV and oral probenecid placebo daily
Gastrointestinal disorders Diarrhoea	0.00% 0/102	2.0% 2/101 • Number of events 2
Gastrointestinal disorders Nausea	0.00% 0/102	0.99% 1/101 • Number of events 1
Gastrointestinal disorders Vomit	2.9% 3/102 • Number of events 3	0.99% 1/101 • Number of events 1
Vascular disorders Infusion Reaction	0.98% 1/102 • Number of events 1	0.00% 0/101
Skin and subcutaneous tissue disorders Rash	0.00% 0/102	0.99% 1/101 • Number of events 1

Additional Information

Dawn Dalen

Interior Health

Phone: 250-862-4449

Email: dawn.dalen@interiorhealth.ca

Results disclosure agreements

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