Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-04-30

Brief Summary

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Secondary infections remain a major cause of mortality in critically ill patients, mainly because of high prevalence of multidrug-resistant microorganisms. Therefore strategies aimed to reduce the incidence of ventilator-associated pneumoniae (VAP) and bloodstream infections are of utmost important. There is robust data on selective digestive decontamination (SDD) efficacy in reduction of secondary infections in intensive care units (ICU) with low rates of antibacterial resistance. However the data received from hospitals with moderate-to-high rates of resistance is equivocal.

This as an interventional parallel open-label study investigating the effect of selective digestive decontamination on the rates of ventilator-associated pneumonia in critically ill patients admitted to the ICU with high prevalence of drug-resistant bacteria. Secondary outcomes include rates of bloodstream infections, mortality, duration of mechanical ventilation, duration of ICU stay, resistance selection and overall antibiotic consumption.

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Detailed Description

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Single-center prospective interventional parallel study. During the first period of the study patients will receive standard therapy. During the second period the SDD protocol will be implemented in addition to the standard care. The first period will end at the moment of the last admitted patient ICU discharge or death.

Study population: general ICU adult patients anticipated to receive prolonged mechanical ventilation (more than 48 hours). Patients who are terminally ill and are anticipated to die in the next 24 hours will be excluded, so are patients with malignancies (except for patients with primary central nervous system tumors who received radical treatment) and patients admitted from other hospitals who received mechanical ventilation (including non-invasive ventilation) for more than 24 hours.

Patients in the interventional arm will receive the following SDD protocol:

1. Oral paste (0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B/500000 U of nistatin q6h
2. In the nasogastric tube (NGT) 10 ml of suspension containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B/8000000 U of nistatin and 500 mg of vancomycin q6h
3. A 3-day course of intravenous cefotaxime 1 g q6h/ceftriaxone 1 qd

Statistical considerations and recruitment plant: VAP incidence in the ICU with high rates of antibacterial resistance is 16,7 event per 1000 days of MV. To reveal a 25% decrease of VAP events (power 80%, p \< 0,05) the study should recruit 25 patients in each group. However because of the poor prognosis in mechanically ventilated elderly patients especially in the setting of acute respiratory distress syndrome the goal is to recruit in each arm at least 25 patients younger than 65 years.

Conditions

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Pneumonia, Ventilator-Associated Pneumonia Bloodstream Infection Sepsis Respiratory Distress Syndrome Respiratory Tract Infections Critical Illness

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

During the first period patients will receive standard care. During the second period SDD protocol will be implemented.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control group: standard care

Patients in the standard care group will be prospectively evaluated to determine pre-defined clinical outcomes.

Group Type NO_INTERVENTION

No interventions assigned to this group

Selective digestive decontamination group

1. Oral paste (0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B q6h
2. In the NGT 10 ml of suspension containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B and 500 mg of vancomycin q6h
3. A 3-day course of intravenous cefotaxime 1 g q6h/ceftriaxone 1 qd

Group Type EXPERIMENTAL

Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h

Intervention Type DRUG

The oral paste will be applied topically on the oropharyngeal mucosa q6h.

Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h

Intervention Type DRUG

The suspension will be administered through the nasogastric tube q6h.

Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd

Intervention Type DRUG

Patients who do not receive systemic antibiotics for other reasons will get a short course of systemic antibiotic

Interventions

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Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h

The oral paste will be applied topically on the oropharyngeal mucosa q6h.

Intervention Type DRUG

Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h

The suspension will be administered through the nasogastric tube q6h.

Intervention Type DRUG

Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd

Patients who do not receive systemic antibiotics for other reasons will get a short course of systemic antibiotic

Intervention Type DRUG

Other Intervention Names

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Polymyxin B, Gentamycin, Amphotericine B, Nistatin Polymyxin B, Gentamycin, Amphotericine B, Vancomycine, Nistatin Cefotaxime, Ceftriaxone

Eligibility Criteria

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Inclusion Criteria

* Patients with expected MV for more than 24 hours

Exclusion Criteria

* Moribund condition and expected death within 24 hours
* Malignancy (excluding primary CNS tumors)
* Patients transferred from other hospitals who were mechanically ventilated for more than 24 hours (including NIV)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No