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NCT Number: NCT02795949

Study on Reduced Antibiotic Treatment vs Broad Spectrum Betalactam in Patients With Bacteremia by Enterobacteriaceae

The continuous increase in the bacterial resistance rate and the slow arrival of new therapeutic options have turned into an antibiotic crisis. One of the strategies proposed by stewardship programs to try to change this situation described worldwide is the use of antibiotics with the lowest possible antimicrobial spectrum.

Enterobacteriaceae bacteremia is a good example of how this strategy would be applied. The empirical treatment of nosocomial bacteremia by Enterobacteriaceae comprises in several cases one or two antibiotics with antipseudomonal activity, being much less common than desirable a subsequent change to narrower spectrum antibiotics based on susceptibility data ("de escalation"). This is because the safety of de escalation is based only on expert advice and some observational studies, so their efficacy and safety is questioned by many clinicians and therefore its use is lower than desired. In fact, a recent systematic review of the Cochrane Library concluded that randomized studies to support this practice are needed. Investigators propose a "real clinical practice-based" randomized trial to compare the efficacy and safety of continuing with an antipseudomonal agents vs. de-escalation according to a pre-specified rule, in patients with bacteraemia due to Enterobacteriaceae.

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Key information

Conditions

Enterobacteriaceae Infections Bacteremia Bacterial Infections Bacterial Infections and Mycoses Disease Attributes Gram-Negative Bacterial Infections Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Cruces Hospital, Barakaldo, Basque Country, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years old hospitalized patients with bacteremia from any source with isolation of an enterobacteria in blood cultures.
  • Active empiric treatment with antipseudomonal betalactamic at 48 hours from the symptoms of sepsis and the blood culture.The patient could have received any other type of antibiotic therapy up to 24 hours after blood extraction.
  • Microorganism susceptible at least one treatment from the experimental arm.
  • Patients with intravenous treatment at least 3 days from the randomization o 5 days from the initial blood culture.
  • Patients to sign the informed consent form.

Exclusion criteria

  • Palliative care or life expectance < 90 days.
  • Pregnancy or lactation period.
  • To isolate the Extended-spectrum β-lactamases producing Enterobacteriaceae
  • Late randomization >48 hours after the enterobacteriaceae blood culture´s identification
  • Severe neutropenic (< 500 céls/mm3) at the randomization.
  • Treatment of infection > 28 days (endocarditis and osteomyelitis) or meningitis.

Treatment and study plan

Antipseudomonal beta-lactam antibiotic

Drug

Pharmaceutical form: solution for infusion

Other names: Ampicillin, Trimethoprim/sulfamethoxazole, Cefuroxime, Amoxicillin/clavulanate, Ciprofloxacin, Ertapenem

De-escalation(short-spectrum antibiotic)

Drug

Pharmaceutical form: solution for infusion

Other names: Piperacillin/tazobactam, Meropenem, Imipenem, Aztreonam, Ceftazidime, Cefepime

Primary outcomes

  1. Clinical cure at day 3-5 after treatment.

    Time frame: Day 3-5 after end of treatment.

    Clinical cure: complete resolution of infection symptoms (bacteremia) present at the day on which the assessment is done and patient is alive.

Secondary outcomes

  1. Early clinical and microbiological response.

    Time frame: After 5 days of treatment

    The infection was completely resolved after 5 days of treatment (patients without infection symptoms and a negative blood culture).

  2. Late clinical and microbiological response.

    Time frame: Day 60

    The infection was completely resolved at day 60 (patients without infection symptoms)

  3. Mortality

    Time frame: At 7,14 and 30 days

    Death for any reason

  4. Length of hospital stay

    Time frame: At 7,14 and 30 days

    Defined as the from admission to hospital discharge

  5. Recurrences (relapse or reinfection) rate

    Time frame: Day 60 after treatment

  6. Safety of antibiotic treatment

    Time frame: 60 days

    Gathering any related adverse event from the informed consent form signature up to 60 days

  7. Impact of the study treatment on intestinal microbiota

    Time frame: Screening, Day 7-14, Day 12-21, Day 30

    Effect of study treatment on colonization of the intestinal tract with multi drug resistant gram negative bacilli

  8. Treatment duration.

    Time frame: It is not allowed treatment duration more than 28 days

    Evaluate the study treatment duration.

  9. Secondary infections.

    Time frame: 60 days

    Evaluate the development of secondary infections other than the initial bacteremia.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Collaborators

  • Spanish Network for Research in Infectious Diseases

Registry information

Official study title

Randomized, Multicenter, Phase III, Controlled Clinical Trial, to Demonstrate the no Inferiority of Reduced Antibiotic Treatment vs a Broad Spectrum Betalactam Antipseudomonal Treatment in Patients With Bacteremia by Enterobacteriaceae

Acronym: SIMPLIFY

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jun 10, 2016
Registry last updated
Jul 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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