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Published on: August 30, 2018
Antibiotic prophylaxis of early onset pneumonia in critically ill comatose patients. A randomized study
A Acquarolo1, T Urli, G Perone
1Institute of Anesthesiology-Intensive Care, University of Brescia Spedali Civili, Piazzale Ospedali Civili 1, 25125 Brescia, Italy. a.acquarolo@tiscali.it
Insights
A 3-day ampicillin-sulbactam prophylaxis significantly reduced early-onset pneumonia (EOP) in comatose, mechanically ventilated patients. This antibiotic strategy lowered EOP occurrence by 64%, suggesting a potential new preventative measure for critically ill patients.
Area of Science:
- Critical Care Medicine
- Infectious Diseases
- Pharmacology
Background:
- Comatose, mechanically ventilated patients are at high risk for hospital-acquired infections, particularly pneumonia.
- Early-onset pneumonia (EOP) in this vulnerable population contributes to increased morbidity and mortality.
- Prophylactic antibiotic strategies are being explored to mitigate infection risk in intensive care units (ICUs).
Purpose of the Study:
- To investigate the efficacy of a 3-day ampicillin-sulbactam prophylaxis in preventing early-onset pneumonia (EOP).
- To assess the impact of this prophylaxis on critically ill, comatose, and mechanically ventilated patients.
Main Methods:
- A single-center, prospective, randomized, open-label study was conducted.
- Comatose mechanically ventilated patients with brain injury were randomized to receive either ampicillin-sulbactam prophylaxis plus standard care or standard care alone.
- The primary endpoint was the occurrence of EOP.
Main Results:
- The ampicillin-sulbactam prophylaxis group showed a statistically significant reduction in EOP.
- EOP occurred in 21.0% of patients receiving prophylaxis versus 57.9% in the standard treatment group (P = 0.022).
- This represents a 64% relative risk reduction in EOP, with a number needed to treat of three.
Conclusions:
- A 3-day course of ampicillin-sulbactam prophylaxis effectively reduced the incidence of EOP in comatose, mechanically ventilated patients.
- The findings support further investigation in larger multicenter trials to confirm mortality benefits and assess potential impacts on antibiotic resistance.
Objective:
To evaluate if a 3-day ampicillin-sulbactam prophylaxis can reduce the occurrence of early-onset pneumonia (EOP) in comatose mechanically-ventilated patients.
Design:
This was a single-centre, prospective, randomised, open study.
Setting:
A 10-bed general-neurological ICU in a 2,000-bed university hospital.
Patients And Participants:
Comatose mechanically-ventilated patients with traumatic, surgical or medical brain injury.
Interventions:
Patients were randomized to either ampicillin-sulbactam prophylaxis (3 g every 6 h for 3 days) plus standard treatment or standard treatment alone.
Measurements And Results:
Main outcome was the occurrence of EOP. Secondary outcome measures were occurrence of late-onset pneumonia, percentage of non-pulmonary infections and of emerging multiresistant bacteria, duration of mechanical ventilation and of ICU stay and ICU mortality. Interim analysis at 1 year demonstrated a statistically significant reduction of EOP in the ampicillin-sulbactam group, and the study was interrupted. Overall, 39.5% of the patients developed EOP, 57.9% in the standard treatment group and 21.0% in the ampicillin-sulbactam group (chi-square 5.3971; P =0.022). Relative risk reduction of EOP in patients receiving ampicillin-sulbactam prophylaxis was 64%; the number of patients to be treated to avoid one episode of EOP was three. No differences in other outcome parameters were found; however, the small sample size precluded a definite analysis.
Conclusions:
Antibiotic prophylaxis with ampicillin-sulbactam significantly reduced the occurrence of EOP in critically ill comatose mechanically ventilated patients. This result should encourage a large multicenter trial to demonstrate whether ampicillin-sulbactam prophylaxis reduces patient mortality, and whether antibiotic resistance is increased in patients receiving prophylaxis.
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