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.
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.
Ferreira
João Batista
JB
Otolaryngology Department, Medical School of the UFG, Brazil. algmnp@uol.com.br
Rapoport
Priscila Bogar
PB
Sakano
Eulália
E
Kós
Arthur Octávio De Avila
AO
Piltcher
Otávio B
OB
Pignatari
Shirley Shizue Nagata
SS
Pinheiro
Sebastião Diógenes
SD
Mocellin
Marcos
M
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
D000900:Anti-Bacterial Agents; C035444:sultamicillin; D019980:Amoxicillin-Potassium Clavulanate Combination; D000667:Ampicillin; D013407:Sulbactam