bacampicillin and Otitis-Media

In randomized, double-blind trials of antibiotic therapy for acute otitis media that determined both clinical and bacteriologic outcomes, clinical success rates were (93%) 236 of 253 for patients with bacteriologic success, (62%) 25 of 40 for those with bacteriologic failure, and (80%) 124 of 155 for those with nonbacterial acute otitis media. These rates were used to calculate the effectiveness of three strategies for assessing drug efficacy: (1) tympanocentesis and culture before and during therapy (bacteriologic efficacy), (2) tympanocentesis before therapy and assessment of clinical efficacy in bacterial acute otitis media, and (3) no tympanocentesis and assessment of clinical efficacy in clinical (total) acute otitis media. For a drug with a bacteriologic efficacy of 100%, calculated clinical efficacy was 93% for bacterial acute otitis media and 89% for clinical acute otitis media. For a drug with bacteriologic efficacy of 27%, a rate consistent with no antibacterial therapy, efficacy was 71% for bacterial acute otitis media and 74% for clinical acute otitis media. We conclude that if efficacy is measured by symptomatic response, drugs with excellent antibacterial activity will appear less efficacious than they really are and drugs with poor antibacterial activity will appear more efficacious than they really are. The predominant phenomenon is that drugs with poor antibacterial activity will appear to be clinically effective in the treatment of acute otitis media.

Topics: Acute Disease; Amoxicillin; Ampicillin; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Cefaclor; Cefixime; Cefotaxime; Clavulanic Acid; Clavulanic Acids; Double-Blind Method; Drug Combinations; Efficiency; Enzyme Inhibitors; Female; Haemophilus influenzae; Humans; Infant; Male; Moraxella catarrhalis; Otitis Media; Punctures; Streptococcus pneumoniae; Treatment Outcome; Trimethoprim, Sulfamethoxazole Drug Combination; Tympanic Membrane

Nine hundred and eleven patients were admitted to a multicentre trial with bacampicillin (Penglobe) in respiratory tract infections. Of these it was possible to evaluate 830 with respect to efficacy and side-effects. In most cases a dosage of 400 mg X 2 was used but in severe cases 800 mg X 2 was used. The clinical outcome was assessed as good for 79% of the patients, while 17% showed an improvement and 3% a failure. The tolerance was good with an over-all incidence of 8% side-effects, of which dyspepsia was the most common.

Topics: Ampicillin; Belgium; Bronchitis; Bronchopneumonia; Clinical Trials as Topic; Drug Eruptions; Drug Tolerance; Dyspepsia; Family Practice; Humans; Otitis Media; Respiratory Tract Infections; Tonsillitis

Topics: Acute Disease; Amoxicillin; Ampicillin; Child; Child, Preschool; Clinical Trials as Topic; Double-Blind Method; Humans; Infant; Otitis Media; Otitis Media with Effusion

Topics: Adult; Ampicillin; Bacteria; Bacterial Infections; Clinical Trials as Topic; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Otitis Media; Paranasal Sinus Diseases; Pharyngitis

We studied the concentration of ampicillin (ABPC) into middle ear effusions after administration of bacampicillin (BAPC). Nine patients with acute purulent otitis media were given orally single doses of the drug at a level of 10 mg/kg, and concentrations of ABPC which is the active antibiotic metabolite of BAPC were determined in middle ear effusions periodically after the administration. Bacteria present in effusions were identified, and their ability to produce beta-lactamase was also determined. ABPC concentrations in middle ear effusions were inversely related to the ability of bacteria detected from the intratympanic cavity to produce beta-lactamase. ABPC concentrations in middle ear effusions from which only beta-lactamase negative organisms were detected were higher by 5.2- and 2.3- fold at 60 and 120 minutes after the administration of BAPC, respectively, than those in effusions from which beta-lactamase positive organisms were detected. ABPC concentrations achieved in middle ear effusions in cases where only beta-lactamase negative organisms were detected exceeded MIC80's of the drug against main causative bacteria of acute purulent otitis media such as Streptococcus pneumoniae, Streptococcus pyogenes, and Haemophilus influenzae. Because only 10% or less of these species produces beta-lactamase, BAPC appears to be one of the highly effective drugs in the treatment of this disease.

Topics: Acute Disease; Administration, Oral; Ampicillin; Child; Child, Preschool; Drug Evaluation; Ear, Middle; Exudates and Transudates; Female; Humans; Male; Otitis Media; Otitis Media, Suppurative

Topics: Amoxicillin; Ampicillin; Cyclacillin; Dermatitis; Diarrhea; Humans; Intestinal Absorption; Otitis Media; Pivampicillin; Urinary Tract Infections