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

> **NCT04839653** · NA · UNKNOWN · sponsor: **MEDSI Clinical Hospital 1, ICU** · enrollment: 60 (estimated)

## Conditions studied

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

## Interventions

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

## Key facts

- **NCT ID:** NCT04839653
- **Lead sponsor:** MEDSI Clinical Hospital 1, ICU
- **Sponsor class:** OTHER
- **Phase:** NA
- **Study type:** INTERVENTIONAL
- **Status:** UNKNOWN
- **Start date:** 2021-05-01
- **Primary completion:** 2022-04
- **Final completion:** 2023-04
- **Target enrollment:** 60 (ESTIMATED)
- **Last updated:** 2021-06-08


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT04839653

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT04839653, "Efficacy and Safety of Selective Digestive Decontamination in the ICU With High Rates of Antibiotic-resistant Bacteria". Retrieved via AI Analytics 2026-05-27 from https://api.ai-analytics.org/clinical/NCT04839653. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
