title: Efficacy and safety of Sultamicillin (Ampicillin/Sulbactan) and Amoxicillin/Clavulanic acid in the treatment of upper respiratory tract infections in adults--an open-label, multicentric, randomized trial.
abstract: Upper respiratory tract infections are the most common causes of medical visits in children and adults, demanding massive use of antibiotics. Bacterial resistance caused by beta-lactamase is one of the most serious problems in this matter. Sultamicillin, a double pro-drug of Ampicillin/Sulbactan, is a potent beta-lactamase inhibitor which can face this challenge.
  
  
  OBJECTIVE
  Evaluate efficacy, safety and tolerability of Ampicillin/Sulbactan compared to Amoxicillin/Clavulanate in upper respiratory tract infections in adults.
  
  
  METHODS
  102 patients were enrolled and randomized to receive Ampicillin/Sulbactan or Amoxicillin/Clavulanate during 10 days. They were evaluated 10 and 30 days after treatment to learn about the therapeutic response.
  
  
  RESULTS
  There were no differences between the two groups respecting cure at the end of treatment (visit 2) or at the end of the study (visit 3). Cure ratio was 61.7% and 93.2% (visits 2 and 3) in the Amoxicillin/Clavulanate group compared to 64.4% and 97.4%, respectively, in Ampicillin/Sulbactan group. The adverse events ratio for the two groups was the same (p=0.940). The number of patients with diarrhea was greater in the group of patients receiving Amoxicillin/Clavulanate (70.6%) than in the group receiving Ampicillin/Sulbactan (29.4%) (p=0.0164).
  
  
  CONCLUSIONS
  Ampicillin/Sulbactan is as safe and efficient as Amoxicillin/Clavulanate in the empiric treatment of upper respiratory infections in adults. The low occurrence of diarrhea in the group receiving Ampicillin/Sulbactan needs confirmation in other studies.
authors.affiliation: Otolaryngology Department, Medical School of the UFG, Brazil. algmnp@uol.com.br
authors.forename: João Batista
authors.initials: JB
authors.lastname: Ferreira
authors.forename: Priscila Bogar
authors.initials: PB
authors.lastname: Rapoport
authors.forename: Eulália
authors.initials: E
authors.lastname: Sakano
authors.forename: Arthur Octávio De Avila
authors.initials: AO
authors.lastname: Kós
authors.forename: Otávio B
authors.initials: OB
authors.lastname: Piltcher
authors.forename: Shirley Shizue Nagata
authors.initials: SS
authors.lastname: Pignatari
authors.forename: Sebastião Diógenes
authors.initials: SD
authors.lastname: Pinheiro
authors.forename: Marcos
authors.initials: M
authors.lastname: Mocellin
mesh_terms: D000328:Adult; D019980:Amoxicillin-Potassium Clavulanate Combination / Q000009:adverse effects / Q000627:therapeutic use*; D000667:Ampicillin / Q000009:adverse effects / Q000627:therapeutic use; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D013407:Sulbactam / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; C035444:sultamicillin; D019980:Amoxicillin-Potassium Clavulanate Combination; D000667:Ampicillin; D013407:Sulbactam