Trial record 6 of 64 for:    Open Studies | "Bacteremia"

Efficacy of Daptomycin Plus Fosfomycin Versus Daptomycin for Treatment of MRSA Bacteremia

This study is currently recruiting participants.
Verified January 2014 by Spanish Network for Research in Infectious Diseases
Sponsor:
Collaborator:
Hospital Universitari de Bellvitge
Information provided by (Responsible Party):
Miquel Pujol, Spanish Network for Research in Infectious Diseases
ClinicalTrials.gov Identifier:
NCT01898338
First received: July 2, 2013
Last updated: January 21, 2014
Last verified: January 2014
  Purpose

To demonstrate that the combination of daptomycin and fosfomycin is superior to daptomycin alone in the treatment of Methicillin resistant Staphylococcus aureus (MRSA) bacteremia.


Condition Intervention Phase
Staph Aureus Methicillin Resistant Bacteremia
Drug: Fosfomycin 2gr/6h iv
Drug: Daptomycin 10mg/kg/24h iv
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Multicenter Study to Assess Efficacy of Daptomycin Plus Fosfomycin Versus Daptomycin Monotherapy for Treatment of Methicillin Resistant Staphylococcus Aureus Bacteremia in Hospitalized Patients

Resource links provided by NLM:


Further study details as provided by Spanish Network for Research in Infectious Diseases:

Primary Outcome Measures:
  • Therapy response [ Time Frame: at 6th week post therapy (an average of 8 to 10 weeks from the beginnig of therapy) ] [ Designated as safety issue: No ]
    Therapy response is considered if clinical and microbiological response is achieved at 6th week post therapy


Secondary Outcome Measures:
  • Mortality [ Time Frame: participants will be followed an average of 8 to 10 weeks from the begining of therapy ] [ Designated as safety issue: No ]
  • Severe adverse effects [ Time Frame: participants will be followed an average of 8 to 10 weeks from the begining of therapy ] [ Designated as safety issue: Yes ]
    whatever

  • Number of persistent bacteremia [ Time Frame: participants will be followed an average of 8 to 10 weeks from the begining of therapy ] [ Designated as safety issue: No ]
    Defined as a persistent positive blood culture at day 7 of therapy.

  • Bacteremia recurrence [ Time Frame: participants will be followed an average of 8 to 10 weeks from the begining of therapy ] [ Designated as safety issue: No ]
    Defined as a positive blood culture to MRSA when a previous negative sample existed

  • Therapy response [ Time Frame: at the end of therapy (up to 4 weeks) ] [ Designated as safety issue: No ]
    Therapy response is considered if clinical and microbiological response is achieved at the end of therapy.


Estimated Enrollment: 206
Study Start Date: November 2013
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fosfomycin and Daptomycin
fosfomycin 2gr/6h + 10mg/kg/24h iv during 14 or 28 days
Drug: Fosfomycin 2gr/6h iv Drug: Daptomycin 10mg/kg/24h iv
Active Comparator: Daptomycin
daptomycin 10mg/kg/cada 24h iv during 14 or 28 days
Drug: Fosfomycin 2gr/6h iv

Detailed Description:

The mortality associated to MRSA bacteremia remains higher than 30% of episodes. Objective: To demonstrate that the combination of daptomycin and fosfomycin is superior to daptomycin alone in the treatment of Methicillin resistant Staphylococcus aureus (MRSA) bacteremia. Design: Randomized, open and multicenter study. Intervention: Patients with MRSA bacteremia will be randomized (1:1) in Group 1: Daptomycin 10mg/Kg/24h intravenous (iv) and Group 2: Daptomycin 10 mg/kg/24 iv and Fosfomycin and 2g/6h iv. The duration of treatment is 10-14 days for uncomplicated bacteremia and 28 days for complicated bacteremia. There will be a clinical and microbiological evaluation at baseline, during treatment and at 6 weeks after the end of therapy. Complicated bacteremia: a) persistent bacteremia at 96 h from the onset of the antibiotic, b) presence of distant source c) infection of 4 days non-removable device. Assuming 60% cure rate with daptomycin and difference in cure rates of 20% between both groups, we estimated that 103 patients would need to be enrolled in each group. Main objective: clinical and microbiological response at 6 weeks from stopping treatment. Treatment success was defined as resolution of sepsis symptoms and clinical signs and negative blood cultures. Therapeutic failure was defined as either of the following: a) Lack of response at 72 h after initiation of treatment or later based on clinical assessment b) persistent bacteremia, c) withdrawal of treatment due to adverse effects or clinical judgment. Secondary objectives: evaluation in both groups of clinical and microbiological response and mortality at the end of treatment, persistent bacteremia and recurrent bacteremia, emergence of daptomycin or fosfomycin resistance and adverse effects.

  Eligibility

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

Inclusion Criteria:

  • Patients with at least 1 positive blood culture to MRSA Staphylococcus aureus within de first 72h from the recruitment.
  • Adult patients, equal or older than 18 years old
  • Signed informed consent
  • Mandatory use of contraceptive for fertile women during the study period and the next 6 months to finalization.

Exclusion Criteria:

  • Polymicrobial bacteremia
  • Pneumonia associated to the bacteremia
  • Severe clinical status with a survival expectancy inferior to 24 hours.
  • Allergy to daptomycin or Fosfomycin
  • Positive pregnant test at inclusion time
  • Clinical status required the addition of other antibiotic therapy with microbiological activity against MRSA, and it's not possible to stop it.
  • Patient included in another clinical trial
  • History od eosinophilic pneumoniae
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01898338

Contacts
Contact: Miquel Pujol, MD, PhD +34 93 260 73 83 ext 7383 mpujol@bellvitgehospital.cat
Contact: Evelyn Shaw, MD +34 93 260 73 83 ext 7383 evelyn.shaw@bellvitgehospital.cat

Locations
Spain
Hospital de la Santa Creu i Sant Pau Recruiting
Bacelona, Barcelona, Spain, 08025
Principal Investigator: Joaquin Lopez-Contreras, MD         
Hospital Universitari de Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Principal Investigator: Miquel Pujol, MD, PhD         
Hospital Parc Taulí Recruiting
Sabadell, Barcelona, Spain, 08208
Principal Investigator: Oriol Gasch, MD         
Hospital de Terrassa Not yet recruiting
Terrassa, Barcelona, Spain, 08227
Principal Investigator: Helena Espejo, MD         
Hospital Universitari Mútua de Terrassa Recruiting
Terrassa, Barcelona, Spain, 08221
Principal Investigator: Esther Calbo, MD, PhD         
Hospital Universitario de Cruces Recruiting
Barakaldo, Spain, 48903
Principal Investigator: Miguel Montejo, MD         
Hospital Clinic Recruiting
Barcelona, Spain, 08036
Principal Investigator: Alex Soriano, MD, PhD         
Hospital del Mar- Parc de Salut Mar Recruiting
Barcelona, Spain, 08003
Principal Investigator: Milagro Montero, MD, PhD         
Hospital Vall d'Hebron Not yet recruiting
Barcelona, Spain, 08035
Principal Investigator: Carles Pigrau, MD, PhD         
Hospital Universitario Virgen de las Nieves Recruiting
Granada, Spain, 18014
Principal Investigator: Juan Pasquau, MD         
Hospital Universitari Arnau de Vilanova Not yet recruiting
Lleida, Spain, 25198
Principal Investigator: Fernando Barcenilla, MD         
Hospital General Gregorio Marañon Recruiting
Madrid, Spain, 28007
Principal Investigator: Belen Padilla, MD         
Hospital Ramon y Cajal Not yet recruiting
Madrid, Spain, 28034
Principal Investigator: Vicente Pintado, MD         
Hospital Universitario 12 de Octubre Not yet recruiting
Madrid, Spain, 28041
Principal Investigator: Ana Garcia-Reyne, MD         
Complejo Asistencial Son Espases Not yet recruiting
Palma de Mallorca, Spain, 07120
Principal Investigator: Javier Murillas, MD, PhD         
Hospital Virgen Macarena Not yet recruiting
Sevilla, Spain, 41071
Principal Investigator: Jesús Rodriguez-Baño, MD, PhD         
Hospital Universitari Joan XXIII Not yet recruiting
Tarragona, Spain, 43007
Principal Investigator: Graciano Garcia Pardo, MD         
Hospital Universitari i Politèncic La Fe Not yet recruiting
Valencia, Spain, 46026
Principal Investigator: Miguel Salavert, MD         
Sponsors and Collaborators
Miquel Pujol
Hospital Universitari de Bellvitge
Investigators
Study Director: Miquel Pujol, MD, PhD (Infectious Diseases Service) Hospital Universitari de Bellvitge
  More Information

Publications:

Responsible Party: Miquel Pujol, MD and PhD, Spanish Network for Research in Infectious Diseases
ClinicalTrials.gov Identifier: NCT01898338     History of Changes
Other Study ID Numbers: BACSARM, 2013-000586-37
Study First Received: July 2, 2013
Last Updated: January 21, 2014
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Spanish Network for Research in Infectious Diseases:
MRSA
bacteremia
therapy

Additional relevant MeSH terms:
Bacteremia
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Fosfomycin
Daptomycin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014