Trial Outcomes & Findings for Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment (NCT NCT01199783)

NCT ID: NCT01199783

Last Updated: 2024-03-18

Results Overview

Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy by doctoral's decision For each of the patients included in the study the clinical outcome at TOC should be assessed using the following criteria: Cure: resolution of all clinical signs and symptoms of infection and a healing wound after ≥ 5 days of therapy Improvement: resolution of ≥ 2 - but not all- clinical signs and symptoms of infection after ≥ 5 days of therapy (only used at the end of therapy) Failure: persistence or progression of baseline clinical signs and symptoms of infections after ≥ 2 days of therapy Missing: patients received therapy for less than 2 days Indeterminate: circumstances preclude classification Duration of Treatment The duration of treatment will be evaluated as the number of inpatient and outpatient days the patient received antibiotic therapy, even if non-consecutive. Time to Clinical Improvement If according to the patient record

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 1 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2024-03-18

Participant Flow

Trial was prematurely stopped after inclusion of 1 patient who was randomized to the Daptomycin arm. During the trial it became obvious that the patient number to be enrolled is not reachable in prospected time frame, thus, the decision to stop the study prematurely was made.

Participant milestones

Measure	Daptomycin Infusion of Daptomycin (6 mg/kg bodyweight) once daily	Vancomycin Vancomycin once daily (effective blood-plasma concentration of 15 mg/l)
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Application of Daptomycin in MRSA Infected Diabetic Foot in Comparison to Vancomycin Treatment

Baseline characteristics by cohort

Measure	Daptomycin n=1 Participants Infusion of Daptomycin (6 mg/kg bodyweight) once daily	Vancomycin Vancomycin once daily (effective blood-plasma concentration of 15 mg/l)	Total n=1 Participants Total of all reporting groups
Age, Continuous	71 years STANDARD_DEVIATION 0 • n=5 Participants	—	71 years STANDARD_DEVIATION 0 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	—	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Region of Enrollment Germany	1 participants n=5 Participants	—	1 participants n=5 Participants

PRIMARY outcome

Timeframe: 14 days

Population: Participant's infection was solved at day 5 of the study - only 1 participant was treated in the study

Clinical response of the infection at test-of-cure (TOC) at day 14 post therapy by doctoral's decision

For each of the patients included in the study the clinical outcome at TOC should be assessed using the following criteria:

Cure: resolution of all clinical signs and symptoms of infection and a healing wound after ≥ 5 days of therapy Improvement: resolution of ≥ 2 - but not all- clinical signs and symptoms of infection after ≥ 5 days of therapy (only used at the end of therapy) Failure: persistence or progression of baseline clinical signs and symptoms of infections after ≥ 2 days of therapy Missing: patients received therapy for less than 2 days Indeterminate: circumstances preclude classification

Duration of Treatment The duration of treatment will be evaluated as the number of inpatient and outpatient days the patient received antibiotic therapy, even if non-consecutive.

Time to Clinical Improvement If according to the patient record

Outcome measures

Measure	Daptomycin n=1 Participants Infusion of Daptomycin (6 mg/kg bodyweight) once daily Daptomycin: Infusion (6 mg/kg/bodyweight) once daily	Vancomycin Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) Vancomycin: vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
Clinical Response of the Infection at Test-of-cure (TOC) at Day 14 Post Therapy	1 Participants	—

SECONDARY outcome

Timeframe: 14 days

Population: only one participant was randomized and analyzed

Duration of therapy until infection was solved in days

Outcome measures

Measure	Daptomycin n=1 Participants Infusion of Daptomycin (6 mg/kg bodyweight) once daily Daptomycin: Infusion (6 mg/kg/bodyweight) once daily	Vancomycin Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) Vancomycin: vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
Duration of Therapy	5 days	—

SECONDARY outcome

Timeframe: within time frame of 14 days

Population: only one randomized particpant available for evaluation

Number of therapy related complications

Outcome measures

Measure	Daptomycin n=1 Participants Infusion of Daptomycin (6 mg/kg bodyweight) once daily Daptomycin: Infusion (6 mg/kg/bodyweight) once daily	Vancomycin Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) Vancomycin: vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
Therapy Related Complications	0 number of events	—

SECONDARY outcome

Timeframe: within time frame of 14 days

Population: only one participant was randomized and analyzed

• from the clinician point of view (clinical signs and symptoms)
• from microbiological analysis

Outcome measures

Measure	Daptomycin n=1 Participants Infusion of Daptomycin (6 mg/kg bodyweight) once daily Daptomycin: Infusion (6 mg/kg/bodyweight) once daily	Vancomycin Vancomycin once daily (effective blood-plasma concentration of 15 mg/l) Vancomycin: vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
Number of Successful Treatments at TOC	1 Participants	—

SECONDARY outcome

Timeframe: within time frame of 14 days

Population: only one participant was randomized and analyzed, no amputation occured

Rate of amputations due to infection given as number of events per total events in the study in percent

Outcome measures

Outcome data not reported

Adverse Events

Daptomycin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Vancomycin

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

PD Dr. Bernd Stratmann

Herz- und Diabeteszentrum NRW

Phone: +495731973768

Email: bstratmann@hdz-nrw.de

Results disclosure agreements

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