Ampicillin-Sulbactam for the Treatment of Aspiration Pneumonia in Patients with Opioid Overdose: A Randomized Controlled Clinical Trial

Abstract

Background: Aspiration pneumonia is among overdose complications, requiring timely appropriate treatment. The present study aimed to evaluate the effects of ampicillin-sulbactam, compared to our usual regimen ceftriaxone + clindamycin on aspiration pneumonia in opioid-poisoned patients. Methods: In a randomized-controlled clinical trial, opioid-poisoned patients with aspiration pneumonia were randomly divided into the experimental and control groups to receive ampicillin-sulbactam 3 g Intravenously (IV) every 6 hours (experimental group) and ceftriaxone 1 g IV every 12 hours + clindamycin 600 mg IV every 8 hours (control group) followed by co-amoxiclav 625 mg orally every 8 hours and cefixime 400 mg once daily + clindamycin 600 mg orally every 8 hours in experimental and control groups, respectively, to complete a 7-day course of therapy. White blood cell count and temperature (axillary) at baseline and the third day of the intervention and the treatment outcome on the third day of the intervention, defined as either complete response, partial response, or failure, were evaluated and recorded for all patients. Results: Except for the number of cases of leukocytosis on the third day of the intervention, i.e., lower in the control group (5 patients, 26.30%) than the experimental group (13 patients, 68.40%) (P=0.020), no significant difference was observed between the study groups regarding other outcome variables. Clinical response was similar between the study groups; so that, 10.50% and 63.20% of patients in the experimental group and 21.10% and 47.4% of patients in the control group presented complete and partial responses, respectively (P=0.550). Conclusion: The obtained data suggested that ampicillin-sulbactam is an effective antibiotic for the treatment of aspiration pneumonia in patients with opioid overdose, in which case, it has the same efficacy as the two-drug regimen of ceftriaxone + clindamycin.