Fosfomycin Versus Meropenem or Ceftriaxone in Bacteriemic Infections Caused by Multidrug Resistance in E.Coli

Launched by FUNDACIÓN PÚBLICA ANDALUZA PARA LA GESTIÓN DE LA INVESTIGACIÓN EN SEVILLA · May 16, 2014

Keywords

ClinConnect Summary

The FOREST study is a phase 3, randomised, controlled, multicentric, open-label clinical trial to prove the noninferiority of fosfomycin versus meropenem in the targeted treatment of bacteraemic UTI due to ESBL-EC, designed as a real practice trial. It is a non-commercial, investigator-driven clinical study funded through a public competitive call by Instituto de Salud Carlos III, Spanish Ministry of Economy (PI13/01282).

The study is coordinated by investigators from Hospital Universitario Virgen Macarena in Seville, Spain; the sponsorship is performed by Fundación Pública Andaluza para l...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • ≥18 years old hospitalized patients
• • Negative pregnancy test in fertile women
• • Episode of clinically-significant monomicrobial urinary BSI due to multidrug-resistant E.coli susceptible to fosfomycin and meropenem or ceftriaxone
• * Urinary sepsis with multidrug resistant E. coli isolation from the blood cultures, requires at least one clinical criteria and one of the following urinalysis criteria:
• • Clinical criteria
• • UTI symptoms (dysuriac, urgency, suprapubic pain or pollakiuria)
• • Lumbar back pain
• • Cost-vertebral angle tenderness
• • Altered mental status in people up to 70 years old
• • Intermittent or permanent indwelling foley catheter (or withdrawal during 24 hours previous) even without urinary symptoms urinalysis criteria
• • Urine dipstick test positive for either nitrites or leukocyte esterase
• • Positive urine culture - Signed informed consent form (ICF) executed prior to protocol screening assessments
• Exclusion Criteria:
• • Polymicrobial bacteremia
• • No drainage of renal abscess or obstructive uropathy unresolved
• • Pregnant or careening women
• • Haematogenous infection
• • Other concomitant infection
• • Renal transplantation recipients
• • Polycystic kidney
• • Hypersensitivity and/or intolerance to meropenem or fosfomycin or ceftriaxone
• • Palliative care or life expectance \< 90 days
• • Septic shock at time of randomization
• • New York Heart Association (NYHA) functional Class IV, hepatic cirrhosis or renal impairment receiving dialysis
• • Active empiric treatment \>72 hours
• • Late randomization \>24 hours after multidrug resistant.coli blood culture´s identification
• • Participation in other clinical trial with active treatment