Randomized, multicenter, open, controlled clinical trial, to demonstrate the non-inferiority of reduced antibiotic treatment against the treatment of a broad spectrum in treating patients with bacteremia due to enterobacter.

Randomized, multicenter, open, phase III, controlled clinical trial, to demonstrate the non-inferiority of reduced antibiotic treatment directed against the treatment of a broad spectrum betalactam antipseudomonal in treating patients with bacteremia spectrum Enterobacteriaceae

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004219-19-ES

Enrollment

344

Registered

2016-02-03

Start date

2016-03-18

Completion date

Unknown

Last updated

2022-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Monomicrobial bacteremia from any source due to Enterobactericiae MedDRA version: 18.1 Level: PT Classification code 10058857 Term: Enterobacter bacteraemia System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Ampicillin Product Name: Ampicillim Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Ampicillin Other descriptive name: AMPICILLIN, ANHYDROUS Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) ?18 years old hospitalized patients with bacteremia from any source with isolation of an enterobacteria in blood cultures. 2) Active empiric treatment with antipseudomonic betalactamic at 48 hours from the symptoms of sepsis and the blood culture. 3) Microorganism susceptible at least one treatment from the experimental arm. 4) Patients with intravenous treatment at least 5 days. 5) Patients to sign the informed consent form. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 44

Exclusion criteria

Exclusion criteria: 1 )Palliative care or life expectance 48 hours after the enterobactericiae blood culture´s identification 5) Severe neutropenic ( 28 days (endocarditis and osteomyelitis) or meningitis.

Design outcomes

Primary

Measure	Time frame
Main Objective: To demonstrate the clinical non-inferiority of short-spectrum antibiotic treatment compared to extended-spectrum treatment with antipseudomonic betalactamic using clinical cure at 14 days;Secondary Objective: 1)To evaluate the clinical response at 5 days and at 30 days, mortality until to 30 days, lenght of hospital stay and recurrences of both treatment strategies directed. 2) To evaluate the number of days of antibiotic treatment with a beta-lactam avoided antipseudomonal 3) Safety of antiotic treatment included in the protocol. 4) To examine a group of patients about the colonization by multiresistant gram-negative bacilli, and to evaluate the duration of treatment at 30 day after bacteremia diagnosis.;Primary end point(s): Clinical cure at 14 days.;Timepoint(s) of evaluation of this end point: 14 days	—

Measure

Time frame

Main Objective: To demonstrate the clinical non-inferiority of short-spectrum antibiotic treatment compared to extended-spectrum treatment with antipseudomonic betalactamic using clinical cure at 14 days;Secondary Objective: 1)To evaluate the clinical response at 5 days and at 30 days, mortality until to 30 days, lenght of hospital stay and recurrences of both treatment strategies directed. 2) To evaluate the number of days of antibiotic treatment with a beta-lactam avoided antipseudomonal 3) Safety of antiotic treatment included in the protocol. 4) To examine a group of patients about the colonization by multiresistant gram-negative bacilli, and to evaluate the duration of treatment at 30 day after bacteremia diagnosis.;Primary end point(s): Clinical cure at 14 days.;Timepoint(s) of evaluation of this end point: 14 days

—

Secondary

Measure	Time frame
Secondary end point(s): 1) Early clinical and microbiological response at 5 days of treatment. 2) Late clinical and microbiological response at 30 days. 3) Mortality at 7,14 and 30 days and lenght of hospital stay 4) Recurrences rate at 30 days. 5) Rate of adverse reactions. Effect of the rectal colonization of MDRGNB (Multi drug resistant Gram negative bacilli).;Timepoint(s) of evaluation of this end point: 1) 5 days 2) 30 days 3) 7,14 y 30 days. 4) 30 days	—

Measure

Time frame

Secondary end point(s): 1) Early clinical and microbiological response at 5 days of treatment. 2) Late clinical and microbiological response at 30 days. 3) Mortality at 7,14 and 30 days and lenght of hospital stay 4) Recurrences rate at 30 days. 5) Rate of adverse reactions. Effect of the rectal colonization of MDRGNB (Multi drug resistant Gram negative bacilli).;Timepoint(s) of evaluation of this end point: 1) 5 days 2) 30 days 3) 7,14 y 30 days. 4) 30 days

—

Countries

Spain

Contacts

Public ContactLuis Eduardo López Cortes

Andalusian Health Service

luiselopezcortes@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026