Trial Outcomes & Findings for Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis. (NCT NCT00401960)

NCT ID: NCT00401960

Last Updated: 2017-05-03

Results Overview

Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 6 participants
• Primary outcome timeframe: weekly
• Results posted on: 2017-05-03

Participant Flow

Participant milestones

Measure	Adjunctive Daptomycin Group please see study description for study enrollment	Standard of Care Group as per study description
Overall Study STARTED	5	1
Overall Study COMPLETED	0	1
Overall Study NOT COMPLETED	5	0

Reasons for withdrawal

Measure	Adjunctive Daptomycin Group please see study description for study enrollment	Standard of Care Group as per study description
Overall Study Lost to Follow-up	3	0
Overall Study Death	2	0

Baseline Characteristics

Daptomycin as an Adjuvant Agent in the Treatment of Enterococcal Native Valve Endocarditis.

Baseline characteristics by cohort

Measure	Adjunctive Daptomycin Group n=5 Participants please see study description for study enrollment	Standard of Care Group n=1 Participants as per study description	Total n=6 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	0 Participants n=7 Participants	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Age, Continuous	69 years n=5 Participants	74 years n=7 Participants	70 years 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	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: weekly

Population: Study terminated due to insufficient enrollment; therefore data not sufficient for planned analysis

Number of Participants any Grade 3 or 4 toxicity (DAIDS scale); please see adverse event table for details

Outcome measures

Measure	Adjunctive Daptomycin Group n=5 Participants please see study description for study enrollment	Standard of Care Group n=1 Participants as per study description
Number of Participants With Any Grade 3 or 4 Toxicity (DAIDS Scale)	4 Participants	0 Participants

PRIMARY outcome

Timeframe: weekly

Population: study terminated due to inadequate enrollment; therefore data not sufficient for planned analysis

Number of Participants with creatine kinase elevation > 3x upper limit of normal or elevations of serum Cr >= 30% above baseline

Outcome measures

Measure	Adjunctive Daptomycin Group n=5 Participants please see study description for study enrollment	Standard of Care Group n=1 Participants as per study description
Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria Elevate serum creatine kinase > 3X ULN	0 Participants	0 Participants
Number of Participants With Muscle Toxicity or Renal Toxicity, as Determined by Predefined Criteria Elevated serum creatinine >= 30% above baseline	1 Participants	1 Participants

Adverse Events

Adjunctive Daptomycin Group

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adjunctive Daptomycin Group n=5 participants at risk please see study description for study enrollment	Standard of Care Group n=1 participants at risk as per study description
Cardiac disorders hemopericardium	40.0% 2/5 • Number of events 2 • 2 years; however, study terminated due to lack of eligible study participants	0.00% 0/1 • 2 years; however, study terminated due to lack of eligible study participants
Blood and lymphatic system disorders death	20.0% 1/5 • Number of events 1 • 2 years; however, study terminated due to lack of eligible study participants	0.00% 0/1 • 2 years; however, study terminated due to lack of eligible study participants
Renal and urinary disorders Cr elevation	20.0% 1/5 • Number of events 1 • 2 years; however, study terminated due to lack of eligible study participants	0.00% 0/1 • 2 years; however, study terminated due to lack of eligible study participants
Infections and infestations death	20.0% 1/5 • Number of events 1 • 2 years; however, study terminated due to lack of eligible study participants	0.00% 0/1 • 2 years; however, study terminated due to lack of eligible study participants

Other adverse events

Adverse event data not reported

Additional Information

K Rhee

Weill Medical College

Phone: 6469626224

Email: kyr9001@med.cornell.edu

Results disclosure agreements

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