Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated MRSA Bacteremia

NCT01515020 | Terminated Phase 3

• 2 other identifiers: P100110AOM10082
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: The use of daptomycin to treat nosocomial or healthcare-associated bacteremia due to methicillin-resistant S. aureus (MRSA) would increase the proportion of patients whose blood cultures are sterilized after 72 hours by 15% relative to vancomycin and would improve treatment safety. Hypothesis: for MRSA nosocomial or healthcare related bacteriemia treatment, the use of daptomycin versus vancomycin would increase by 15% the proportion of patients with sterilized blood cultures at 72 hours and would increase the treatment safety. Primary objective: To study the efficacy of daptomycin compared to vancomycin on the sterilization of blood cultures after 72 hours of therapy.

Conditions

Nosocomial Infection; Healthcare-associated Infection

Keywords

bacteremia; meticillin-resistant Staphylococcus aureus; nosocomial infection; healthcare-associated infection; rapid molecular diagnostic test

Outcome Measures

Primary Outcomes (1)

• Rates of sterilization of blood cultures after 72 hours of therapy

  To study the efficacy of daptomycin compared to vancomycin on the sterilization of blood cultures after 72 hours of therapy.

  72 hours

Secondary Outcomes (10)

• Clinical cure at D14

  14 days

• Clinical cure at D28

  28 days

• relapse-free clinical and bacteriological cure at D90

  90 days

• treatment duration (in days) before sterilization of blood cultures

  28 days

• side effects occurrence during treatment

  28 days

Study Arms (2)

vancomycin monotherapy

ACTIVE COMPARATOR

vancomycin monotherapy: standard therapy

Drug: vancomycin monotherapy

daptomycin monotherapy

EXPERIMENTAL

daptomycin monotherapy: experimental therapy

Drug: daptomycin monotherapy

Interventions

vancomycin monotherapy DRUG

intravenous therapy by vancomycin

Also known as: intravenous therapy

vancomycin monotherapy

daptomycin monotherapy DRUG

intravenous therapy by daptomycin

Also known as: intravenous therapy

daptomycin monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with nosocomial and/or healthcare-associated bacteremia with Gram-positive cocci in clusters
• Confirmed to be meticillin-resistant S. aureus using a GeneXpert rapid molecular test
• Aged 18 years or older
• Who can receive follow-up for the entire duration of the study, i.e. 90 days

You may not qualify if:

• Known allergy to vancomycin or daptomycin
• Women who are pregnant or breast-feeding
• Patients who have received vancomycin treatment for more than 48 hours between the diagnostic blood culture and randomization
• Specific sites of infection: pneumonia, meningitis, brain abscess, osteitis, polymicrobial infection
• Life expectancy considered to be less than 72 hours
• Severe hepatic impairment (Child C)
• Short-term intravascular catheters which cannot be removed immediately
• Specific sites of infection: osteitis diagnosed between D1 and D5 inclusive
• Permanent foreign material infection (endovascular stents, replacement heart valves or joints, pace maker etc.) which cannot be removed within 36 hours of the first dose of the study drug

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Novartis: collaborator

Study Sites (1)

Hopital Beaujon

Clichy, 92118, France

Location

MeSH Terms

Conditions

Cross Infection; Bacteremia

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacterial Infections; Bacterial Infections and Mycoses; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation

Study Officials

• Bruno FANTIN, Pr

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 23, 2012
• Study Start: May 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: July 1, 2014
• Last Updated: August 26, 2014

Record last verified: 2014-08

Locations

FR (1)