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

This study is currently recruiting participants.
Verified January 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01515020
First received: January 18, 2012
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Nosocomial Infection
Healthcare-associated Infection
 Drug: vancomycin monotherapy
Drug: daptomycin monotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter Trial of Daptomycin Versus Vancomycin in the Treatment of Nosocomial or Healthcare-associated Methicillin-resistant Staphylococcus Aureus Bacteremia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Rates of sterilization of blood cultures after 72 hours of therapy [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
    To study the efficacy of daptomycin compared to vancomycin on the sterilization of blood cultures after 72 hours of therapy.


Secondary Outcome Measures:
  • Clinical cure at D14 [ Time Frame: 14 days ] [ Designated as safety issue: No ]
    Clinical cure at D14

  • Clinical cure at D28 [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Clinical cure at D28

  • relapse-free clinical and bacteriological cure at D90 [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    relapse-free clinical and bacteriological cure at D90

  • treatment duration (in days) before sterilization of blood cultures [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    treatment duration (in days) before sterilization of blood cultures

  • side effects occurrence during treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    side effects occurrence during treatment

  • renal insufficiency [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    renal insufficiency

  • peripheral vein toxicity requiring placement of a central venous catheter [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    peripheral vein toxicity requiring placement of a central venous catheter

  • side effects requiring changes to the study treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    side effects requiring changes to the study treatment

  • duration of hospitalization for bacteremia [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    duration of hospitalization for bacteremia

  • increase of at least 2 dilutions in the MIC of daptomycin and/or vancomycin between the first and last clinical isolates of S. aureus [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    increase of at least 2 dilutions in the MIC of daptomycin and/or vancomycin between the first and last clinical isolates of S. aureus


Estimated Enrollment: 332
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: vancomycin monotherapy
vancomycin monotherapy: standard therapy
 Drug: vancomycin monotherapy
intravenous therapy by vancomycin
Other Name: intravenous therapy
Experimental: daptomycin monotherapy
daptomycin monotherapy: experimental therapy
 Drug: daptomycin monotherapy
intravenous therapy by daptomycin
Other Name: intravenous therapy

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  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA :

  • 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 have given their written consent when this is possible or someone from his/her family, or if not possible, emergency inclusion
  • Who can receive follow-up for the entire duration of the study, i.e. 90 days

EXCLUSION CRITERIA :

  • Known allergy to vancomycin or daptomycin
  • Women who are pregnant or breast-feeding
  • Patients who have received vancomycin treatment for more than 24 hours between the diagnostic blood culture and randomization
  • Specific sites of infection: pneumonia, meningitis, brain abscess, endocarditis, osteitis, polymicrobial infection
  • Life expectancy considered to be less than 72 hours
  • Severe hepatic impairment (Child C
  • Creatinine clearance < 30 ml/mn
  • Short-term intravascular catheters which cannot be removed immediately
  • Endovascular or cardiac devices or stents placed in the last 12 months
  • Osteoarticular prosthesis placed in the last 3 months

EXCLUSION CRITERIA between D1 and D5 inclusive :

  • Specific sites of infection: endocarditis or 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01515020

Contacts
Contact: Bruno FANTIN, Pr (0) 1 40 87 58 90 ext +33 bruno.fantin@bjn.aphp.fr
Contact: Jean-Luc MAINARDI, Pr (0)1 56 09 39 51 ext +33 jean-luc.mainardi@egp.aphp.fr

Locations
France
Hopital Beaujon Recruiting
Clichy cedex, France, 92118
Contact: Bruno FANTIN, Pr     01 40 87 58 90 ext +33     bruno.fantin@bjn.aphp.fr    
Principal Investigator: Bruno FANTIN, Pr            
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Novartis
Investigators
Principal Investigator: Bruno FANTIN, Pr APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01515020     History of Changes
Other Study ID Numbers: P100110, AOM10082
Study First Received: January 18, 2012
Last Updated: January 23, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
bacteremia
meticillin-resistant Staphylococcus aureus
nosocomial infection
healthcare-associated infection
rapid molecular diagnostic test

Additional relevant MeSH terms:
Staphylococcal Infections
Bacteremia
Cross Infection
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
 Gram-Positive Bacterial Infections
Methicillin
Vancomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013