title: Efficacy of amoxicillin-sulbactam, given twice-a-day, for the treatment of community-acquired pneumonia: a clinical trial based on a pharmacodynamic model.
abstract: The present multicenter study reports the results of a clinical trial, designed on the basis of a pharmacodynamic study published previously (Bantar et al., J. Chemother 2000; 12: 223-227) to assess the efficacy of amoxicillin/sulbactam (875 mg/125 mg), given orally twice-a-day for 7 days in the treatment of patients with community-acquired pneumonia (CAP). Eighty-four evaluable subjects older than 19 years with clinical symptoms and features suggestive of CAP, consulting from June 2000 to March 2002 and meeting the PORT risk class I through III, were enrolled in the study. Mean age (y +/- standard deviation) was 46.7 +/- 16.3 and 62% of the patients had some co-morbidity predisposing for CAP. Several individuals (77.4%) fell into a low-risk class (i.e. PORT I or II) and 22.6% of patients belonged to a moderate-risk class at the start of treatment. Six patients (6.45%) had pneumococcal bacteremia. Streptococcus pneumoniae was the organism most frequently isolated (61.9% of all the patients in whom an etiologic diagnosis was made), followed by Haemophilus influenzae. Clinical success was observed in 97.6% of the patients (confidence interval 95%, 94.3%-100%). Almost all the individuals with clinical success became afebrile within the first 3 days of therapy. Ten patients (11.8%) reported mild or moderate adverse events (especially diarrhea) possibly related to the antimicrobial therapy, but this did not lead to withdrawal from the trial. The results of this study suggest that amoxicillin/sulbactam (875 mg/125 mg) is an efficacious and well tolerated option for treating patients with CAP belonging to a low-moderate risk class and support the use of a short, oral (7-day) b.i.d. regimen.
authors.affiliation: Hospital Bocalandro, Buenos Aires, Argentina.
authors.forename: A
authors.initials: A
authors.lastname: Jasovich
authors.forename: J
authors.initials: J
authors.lastname: Soutric
authors.forename: G
authors.initials: G
authors.lastname: Morera
authors.forename: M
authors.initials: M
authors.lastname: Mastruzzo
authors.forename: E
authors.initials: E
authors.lastname: Vesco
authors.forename: M
authors.initials: M
authors.lastname: Izaguirre
authors.forename: L
authors.initials: L
authors.lastname: Mobilia
authors.forename: S
authors.initials: S
authors.lastname: Prieto
authors.forename: D
authors.initials: D
authors.lastname: Franco
authors.forename: D
authors.initials: D
authors.lastname: Curcio
authors.forename: R
authors.initials: R
authors.lastname: Absi
authors.forename: L
authors.initials: L
authors.lastname: Larrateguy
authors.forename: J L
authors.initials: JL
authors.lastname: Bustos
authors.forename: M E
authors.initials: ME
authors.lastname: Oliva
authors.forename: H
authors.initials: H
authors.lastname: Arenoso
authors.forename: C
authors.initials: C
authors.lastname: Bantar
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000658:Amoxicillin / Q000008:administration & dosage*; D017714:Community-Acquired Infections / Q000188:drug therapy; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D018410:Pneumonia, Bacterial / Q000188:drug therapy*; D011446:Prospective Studies; D013407:Sulbactam / Q000008:administration & dosage*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000658:Amoxicillin; D013407:Sulbactam