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Background: The long half-life of azithromycin allows for single-dose oral therapy for acute otitis media (AOM).Objective: This study was designed to compare the efficacy and safety of single-dose azithromycin with 10-day, twice-daily amoxicillin/clavulanate for the treatment of new-onset, uncomplicated AOM in children.Methods: Children aged 6 months to 12 years with new-onset AOM were randomly assigned to receive either a single 30-mg/kg dose of azithromycin or standard-dose amoxicillin/clavulanate (45 mg/kg per day divided BID for 10 days) in a double-blind, double-placebo, multicenter clinical trial. The diagnosis of AOM was based on specific clinical signs and symptoms, and was confirmed by pneumatic otoscopy and acoustic reflectometry (level >/=3). Clinical response was assessed on days 12-16 and 28-32.Results: Mean (SD) age of children receiving azithromycin (n = 173) or amoxicillin/clavulanate (n = 173) was 2.7 (2.3) years and 3.4 (2.8) years, respectively, with 43% and 36%

Children with acute otitis media underwent tympanocentesis and were given a single dose of 30 mg of azithromycin/kg of body weight. At day 28, the overall clinical cure rate was 206 of 242 (85%). Clinical cure rates for patients infected with Streptococcus pneumoniae (67 of 76; 88%) and Haemophilus influenzae (28 of 44; 64%) were consistent with historical rates for the 5-day dosing regimen.

Background: The long half-life of azithromycin allows for single-dose oral therapy for acute otitis media (AOM)., Objective: This study was designed to compare the efficacy and tolerability of single-dose azithromycin with 10-day, twice-daily amoxicillin/clavulanate for the treatment of new-onset, uncomplicated AOM in children., Methods: Children aged 6 months to 12 years with new-onset AOM were randomly assigned to receive either a single 30-mg/kg dose of azithromycin or standard-dose amoxicillin/clavulanate (45 mg/kg administered BID for 10 days) in a double-blind, double-placebo, multicenter clinical trial. The diagnosis of AOM was based on specific clinical signs and symptoms, and was confirmed by pneumatic otoscopy and acoustic reflectometry (level ≥3). Clinical response was assessed on days 12-16 and 28-32., Results: Mean (SD) age of children receiving azithromycin (n = 173) or amoxicillin/clavulanate (n = 173) was 2.7 (2.3) years and 3.4 (2.8) years, respectively, with 43% and 36% ≤2 years of age. Most (53.2%) of the children were boys, and most (51.2%) were white. Clinical success rates (intent-to-treat) for azithromycin and amoxicillin/clavulanate, respectively, were 87% and 88% (95% CI, -9.2 to 6.5) on day 12-16 and 75% and 75% (95% CI, -10.2 to 10.5) on day 28-32. The incidences of treatment-related adverse events for azithromycin and amoxicillin/clavulanate were 16.8% and 22.5%, respectively. Corresponding rates of diarrhea were 6.4% and 12.7%, respectively. Vomiting, which was generally mild, occurred in 7 children in each group. One azithromycin patient and 5 amoxicillin/clavulanate patients discontinued treatment because of adverse events. The compliance rate for azithromycin was significantly higher than that for amoxicillin/clavulanate (99% vs 83%; P<0.001)., Conclusions: In this trial comparing the efficacy of single-dose azithromycin (30 mg/kg) with twice-daily amoxicillin/clavulanate (45 mg/kg) for the treatment of new-onset, uncomplicated AOM, no differences were detected between the 2 regimens. Single-dose azithromycin was generally well tolerated and provides an alternative to conventional oral regimens for AOM.

Objectives: To compare the bacteriologic and clinical efficacy of amoxicillin/clavulanate and azithromycin in patients with acute otitis media (AOM), particularly the ability to eradicate the predominant AOM pathogens from middle ear fluid as assessed by mandatory second tympanocentesis., Methods: In this single blind study 238 infants and children with AOM were randomized to receive amoxicillin/clavulanate (45/6.4 mg/kg/day in two divided doses for 10 days) or azithromycin (10 mg/kg on Day 1, then 5 mg/kg daily on Days 2 through 5). Tympanocentesis was performed before the first dose and repeated on Day 4, 5 or 6. Clinical response was assessed at end of therapy between Days 12 and 14 and at follow-up between Days 22 and 28., Results: Amoxicillin/clavulanate was significantly more likely to eradicate all bacterial pathogens [83% (54 of 65) vs. 49% (35 of 71), P = 0.001] and Haemophilus influenzae [87% (26 of 30) vs. 39% (13 of 33), P = 0.0001] from middle ear fluid than was azithromycin. Amoxicillin/clavulanate was also more likely to eradicate Streptococcus pneumoniae, but the difference was not statistically significant [90% (18 of 20) vs. 68% (13 of 19) [corrected], P = 0.095]. On Days 12 to 14, signs and symptoms were more likely to resolve completely or improve in all culture-positive patients [86% (60 of 70) vs. 70% (51 of 73), P = 0.023] and in those with H. influenzae infections [91% (30 of 33) vs. 65% (22 of 34), P = 0.010] who received amoxicillin/clavulanate compared with those who received azithromycin. Otherwise there were no significant differences between groups in clinical outcomes on Days 12 to 14 or at follow-up., Conclusions: Our findings indicate that amoxicillin/clavulanate has superior bacteriologic and clinical efficacy compared with azithromycin in children with AOM.

Objective: To characterize the acute clinical course and economic burden of nonpolio enteroviral (NPEV) illness in the summer/fall season as seen in private pediatric practice., Methods: We prospectively studied 380 children aged 4 to 18 years with systemic NPEV syndromes presenting to private suburban pediatric practices. Seventy-three asymptomatic controls were concurrently enrolled. Clinical diagnosis of NPEV illness was based on the presence of fever plus at least one of the following: headache and stiff neck (n = 2); myalgia and malaise (n = 105); nonpuritic maculopapular rash (n = 10); papulovesicular stomatitis (n = 214); papular rash of the hands, feet, and mouth (H/F/M) (n = 30); or pleurodynia (n = 11). Study participants were enrolled during a 4-month time span (July-October, 1994) and followed daily for 14 days. A parent symptom diary card and twice weekly phone contacts by study nurses characterized the illness to include the frequency of health care contacts, the necessity for laboratory tests, medication use, and school/work absenteeism., Results: Three hundred seventy-two (98%) children completed the study; 122 (33%) of the patients were confirmed to be infected with NPEV. Confirmed NPEV infection was more frequently observed in Rochester, NY (85/147 = 58%) than in Scottsdale, AZ (32/224 = 14%). The age group 4 to 12 years comprised 79% to 90% of the enrollees, depending on the syndrome. Median duration of illness and median number of missed days of school/summer camp/work for the enrolled patients was: meningitis (7 days ill, 2 days missed), myalgia/malaise (9 days ill, 3 days missed), rash (6 days ill, 4 days missed), stomatitis (7 days ill, 2 days missed), H/F/M (7 days ill, 1 day missed), and pleurodynia (8 days ill, 3 days missed). Direct medical costs varied from $69 per case to $771 per case and indirect costs, attributable primarily to parent missed work and/or sick-child care, varied from $63 per case to $422 per case for H/F/M and meningitis, respectively. In households, H/F/M spread to 50% of siblings and 25% of parents., Conclusions: In our study population, NPEV infection: 1) caused sufficient illness to prompt physician visits in summer and fall; 2) occurred more frequently in 4 to 12 year olds than in adolescents; 3) produced various clinical syndromes concurrently during the same months in the same season of a given year; 4) varied in occurrence geographically; 5) was characterized by numerous symptoms of longer duration than previously recognized; and 6) produced a significant economic impact by generating both direct and indirect costs.

Objective: We identified the pathogens causing persistent and recurrent acute otitis media (AOM) and the clinical efficacy of cefprozil as treatment., Study Design: This was a noncomparative, open label multicenter trial. Children ages 6 months to 12 years with signs and symptoms of AOM and evidence of middle ear effusion, as confirmed by pneumatic otoscopy or tympanometry, underwent tympanocentesis and subsequent treatment with cefprozil (15 mg/kg given twice daily) for 10 days. Patients with recurrent otitis media or failure of previous antibiotic therapy or prophylaxis were particularly sought for the study., Results: Two hundred sixty-two (99%) of 265 enrolled children were considered evaluable. The median age of the study group was 1 year. Ninety-eight (37%) of the children had a history (within 30 days) of prior antibiotic use. Ninety-seven (37%) met our definition of recurrent AOM, 48 (18%) met our definition of persistent AOM and 132 (50%) children had 3 or more previous episodes of acute otitis media within 12 months before study. Eighty-two (31%) of the enrollment tympanocentesis had no growth, 150 (57%) had a single bacterial pathogen and 29 (11%) had multiple bacterial pathogens. Of the 93 Streptococcus pneumoniae pretreatment isolates, 50 (54%) were penicillin-susceptible, 12 (13%) were penicillin-intermediate resistant and 31 (33%) were penicillin-resistant. Of the 75 Haemophilus influenzae pretreatment isolates, 42 (56%) produced beta-lactamase as did 4 (27%) of the 15 Moraxella catarrhalis strains. A satisfactory clinical response by pathogen was found in 75% (70 of 93) with S. pneumoniae, 75% (56 of 75) with H. influenzae and 93% (13 of 14) with M. catarrhalis; the response with single pathogen infections was higher than those with multiple pathogens (118 of 150 (78%) and 17 of 29 (59%), respectively; P = 0.03). The response for patients with isolates of S. pneumoniae that were penicillin-susceptible, -intermediate or -resistant were 39 of 50 (78%), 11 of 12 (92%) and 21 of 31 (68%), respectively. Older children had a satisfactory clinical outcome more frequently than younger children (P < 0.001), and the response to therapy varied for persistent, recurrent and recently untreated AOM (P < 0.01)., Conclusion: Persistent and recurrent AOM involves the same pathogens as recently untreated AOM but bacteria with reduced antibiotic susceptibility may be more frequently present. This noncomparative study suggests that cefprozil 30 mg/kg/day given in two divided doses for 10 days may be effective in the treatment of children with persistent and recurrent AOM.

Background: The prevalence of penicillin-resistant Streptococcus pneumoniae and beta-lactamase-producing Haemophilus influenzae in otitis media infections is increasing; emergence of these pathogens has complicated treatment., Objectives: To evaluate the incidence of penicillin resistance and the in vitro activity of amoxicillin/clavulanate, cefaclor, loracarbef, cefixime, trimethoprim/sulfamethoxazole, azithromycin and clarithromycin in S. pneumoniae isolates. The in vitro activity of azithromycin, clarithromycin and cefaclor was also evaluated in beta-lactamase-positive and -negative isolates of H. influenzae., Methods: Bacterial isolates of S. pneumoniae and H. influenzae were obtained by tympanocentesis and subsequent culture of middle ear effusion from children with acute otitis media enrolled in a multicenter trial. Susceptibility to test agents was assessed by disk diffusion and broth dilution techniques with criteria established by the National Committee for Clinical Laboratory Standards., Results: Nineteen (31%) of the 61 S. pneumoniae isolates were resistant to penicillin. A significantly lower percentage of the S. pneumoniae isolates were resistant to azithromycin (16%) and clarithromycin (11%) than to penicillin, amoxicillin/ clavulanate, cefaclor, loracarbef or cefixime (31% in all cases). Azithromycin was also more active than cefaclor and significantly more active than clarithromycin against the 55 H. influenzae isolates., Conclusions: The susceptibility of resistant and nonresistant strains of S. pneumoniae to azithromycin and clarithromycin and of isolates of H. influenzae to azithromycin, coupled with penetration of azithromycin into the middle ear, may provide a significant advantage in the treatment of otitis media.

Objective: To compare the efficacy and safety of azithromycin and amoxicillin/clavulanate in pediatric acute otitis media., Methods: Investigators from 12 US centers recruited 677 children. In a randomized, double blind, double dummy fashion, participants received either azithromycin suspension (n = 341) once daily for 5 days or amoxicillin/clavulanate suspension (n = 336) in three divided doses daily for 10 days., Results: Among evaluable patients satisfactory clinical response rates (cured and improved) measured 11 days after therapy began were 87.5% in the azithromycin group and 87.9% in the amoxicillin/clavulanate group; corresponding rates at 30 days were 73.5% in the azithromycin and 71.2% in the amoxicillin/clavulanate groups. Relapse rates were comparable for the treatment groups. Treatment-related side effects, primarily gastrointestinal, were reported significantly less frequently with azithromycin (8.8%) than with amoxicillin/clavulanate (30.8%) (P < 0.0001). Two (0.6%) azithromycin patients and 12 (3.6%) amoxicillin/ clavulanate patients discontinued therapy because of treatment-related side effects (P < 0.006 between groups)., Conclusions: In these children with acute otitis media, azithromycin given once daily for 5 days and amoxicillin/clavulanate given three times daily for 10 days had similar efficacy; however, azithromycin was significantly better tolerated.

The efficacy and safety of a 10-day course of ceftibuten oral suspension (9 mg/kg once daily) were compared with those of penicillin V (25 mg/kg/day in 3 divided doses) in children 3 to 18 years old treated for symptomatic pharyngitis and scarlet fever caused by group A beta-hemolytic streptococci (Streptococcus pyogenes). The study was prospective, randomized, multicenter and investigator-blinded; patients were randomized in a 2:1 ratio (ceftibuten:penicillin V). Overall clinical success (cure/improvement) at the primary end point of treatment (5 to 7 days posttherapy) was achieved in 97% (285 of 294) of ceftibuten-treated patients vs. 89% (117 of 132) of penicillin V-treated patients (P < 0.01). Elimination of infecting streptococci 5 to 7 days posttherapy was achieved in 91% (267 of 294) of ceftibuten-treated patients vs 80% (105 of 132) of penicillin V-treated patients (P < 0.01). A significant rise in anti-streptolysin O or anti-DNase B was observed in approximately 30% of patients in both treatment groups. No patient developed rheumatic fever or nephritis. Treatment-related adverse events were similar between the two groups; mild vomiting (2%) was most frequently reported. These data suggest that once daily ceftibuten is as safe as and more effective than three times daily penicillin V for the treatment of group A beta-hemolytic streptococcal pharyngitis.

A randomized, controlled, single blind clinical trial was conducted in children with acute otitis media to evaluate the safety and efficacy of a 10-day course of therapy with ceftibuten 9 mg/kg taken as a single daily dose, up to a maximum daily dose of 400 mg, compared with cefaclor 40 mg/kg/day in three divided doses, up to a maximum of 1 g/day. Patients were evaluated any time from 1 to 3 days after completion of therapy (posttreatment follow-up). A total of 154 patients (106 ceftibuten, 48 cefaclor) were evaluable for efficacy. Clinical success as determined by resolution (cure) or improvement of signs and symptoms of infection were seen in 89 and 88% of patients treated with ceftibuten and cefaclor, respectively, at the posttreatment follow-up visit. At the extended follow-up visit (any time from 2 to 4 weeks after completion of therapy), clinical success was sustained in 88 and 82% of the ceftibuten-treated and cefaclor-treated patients, respectively. A total of 391 patients (264 ceftibuten, 127 cefaclor) were included in the safety analysis. Treatment-related adverse experiences occurred in 8% of ceftibuten-treated patients and 14% of cefaclor-treated patients. All were mild or moderate and the majority were gastrointestinal. There were no deaths or serious adverse events. The results of this study suggest that ceftibuten is an effective and well-tolerated alternative to other antibiotic therapies for the treatment of children with acute otitis media.

The efficacy and safety of ceftibuten (9 mg/kg daily for 10 days) were compared with those of amoxicillin/clavulanate (Augmentin 40 mg/kg/day given every 8 hours for 10 days) in the empiric treatment of acute otitis media in children. This was a multicenter, investigator-blinded study with 1:1 randomization. Overall clinical response and signs and symptoms of otitis were collected prospectively pretreatment, 3 to 5 days during treatment, 1 to 3 days post-treatment and at 2- to 4-week follow-up. In addition to spontaneous reports of other adverse events, gastrointestinal adverse events were prospectively elicited at each visit. Two hundred ninety-six patients (146 ceftibuten and 150 amoxicillin/clavulanate) were treated with at least 1 dose of study medication. Compliance with dosing was assessable with weight of drug consumed in 127 patients in each treatment group. Five percent (6 of 127) of ceftibuten patients and 11% (14 of 127) of amoxicillin/clavulanate patients received < 80% of prescribed drug (P = 0.10) and were therefore not valid. Two hundred twenty-two patients (121 ceftibuten and 101 amoxicillin/clavulanate) received a minimum of 80% of prescribed medication and were compliant with the protocol. Ceftibuten and amoxicillin/clavulanate groups were comparable both for demographic variables and for baseline signs and symptoms.(ABSTRACT TRUNCATED AT 250 WORDS)

The safety and efficacy of clarithromycin was compared with those of amoxicillin-potassium calvulanate for the treatment of acute otitis media in children. In a multicenter, randomized, investigator-blinded trial, 180 patients (6 months to 12 years of age) with acute otitis media were allocated to receive either clarithromycin, 15 mg/kg in two divided doses (n = 90), or amoxicillin-clavulanate, 40 mg/kg in three divided doses (n = 90), for 10 days. Middle ear samples were obtained by tympanocentesis from 175 of 180 patients. Pathogens were isolated from 137 samples (76%). Eighty-six patients in each treatment group were considered for efficacy analysis. Clinical cure or improvement was achieved within 4 days after treatment in 80 (93%) of 86 patients receiving clarithromycin and in 82 (95%) of 86 patients receiving amoxicillin-clavulanate. Recurrence of infection was observed between 5 and 35 days after treatment in 9 (11%) of 80 patients in the clarithromycin group and in 8 (10%) of 82 patients in the amoxicillin-clavulanate group. Middle ear effusion was found with similar frequency at the end of therapy and at follow-up visits in both treatment groups. Mild gastrointestinal signs and symptoms, the most common side effects, were noted in 20% and 52% of patients in the clarithromycin group and the amoxicillin-clavulanate group, respectively (p < 0.001). We conclude that clarithromycin is a safe and effective antimicrobial agent for the treatment of acute otitis media in children.

Objective: To determine whether cephalexin or penicillin is more effective in the treatment of group A beta-hemolytic streptococcal tonsillopharyngitis in children., Design: Randomized, double-blind, crossover study conducted from 1981 to 1984., Setting: Seven pediatric practices in the United States, including private offices and pediatric clinics., Participants: Of the 654 patients, 525 children and adolescents with clinical evidence of tonsillitis or pharyngitis and throat cultures positive for group A beta-hemolytic streptococcal infection were evaluable. Eighty percent of patients completed the study; none were withdrawn because of adverse reaction., Selection Criteria: Children and adolescents who had acute illness suggestive of group A beta-hemolytic streptococcal infection were enrolled in the study. Treatment was continued if the throat culture was positive for group A beta-hemolytic streptococcal infection., Interventions: Four doses of cephalexin and penicillin (27 mg/kg per day) were prescribed to be taken on an empty stomach for 10 days., Measurements/main Results: Symptomatic clinical failure occurred in 8% of penicillin-treated patients and in 3% of cephalexin-treated patients. Bacteriologic failure rates were 11% in the penicillin treatment group and 7% in the cephalexin treatment group. The combined treatment failure rate of clinical relapse plus asymptomatic bacteriologic failure was 19% in the penicillin treatment group and 10% in the cephalexin treatment group. Paired antistreptolysin-O titer increased significantly in 62.3% of penicillin-treated patients and in 64.2% of cephalexin-treated patients. Similarly, anti-DNase B titers rose 52.2% in penicillin-treated patients and 52.4% in cephalexin-treated patients., Conclusion: Cephalexin is a more effective drug than penicillin in the treatment of group A beta-hemolytic streptococcal throat infection in children.

In a multicenter, randomized, investigator-blinded trial, patients were randomly selected to receive either cefpodoxime proxetil or amoxicillin-clavulanate potassium orally for the treatment of acute suppurative otitis media. Patients were seen before, during, and at the end of therapy, and 2 to 3 weeks after completion of therapy. A total of 229 patients, 153 receiving cefpodoxime and 76 receiving amoxicillin-clavulanate were entered into the study; all patients were examined to determine drug safety. A total of 146 patients, 98 in the cefpodoxime group and 48 in the amoxicillin-clavulanate group, completed the study and were examined to determine drug efficacy. End-of-therapy microbiologic eradication rates in assessable patients were 92% for cefpodoxime and 86% for amoxicillin-clavulanate (p = 0.14; 95% confidence interval (CI) on difference: -4.4%, 19.2%). End-of-therapy clinical response rates for assessable patients were as follows: cured, 68% for cefpodoxime and 65% for amoxicillin-clavulanate; improved, 24% for cefpodoxime and 23% for amoxicillin-clavulanate; and failed, 8% for cefpodoxime and 13% for amoxicillin-clavulanate (p = 0.57; 95% CI: -8.4%, 16.5%). Recurrence rates at long-term follow-up were 24% for cefpodoxime-treated patients and 25% for those given amoxicillin-clavulanate. Both drugs were well tolerated; 20.9% of those given cefpodoxime and 31.6% of amoxicillin-clavulanate-treated patients had drug-related adverse medical events (p = 0.102; 95% CI: -23.9%, 2.6%). Gastrointestinal complaints were the most frequently reported drug-related side effect in both groups: 11.8% of cefpodoxime-treated patients and 21.1% of those given amoxicillin-clavulanate (p = 0.076; 95% CI: -20.8%, 2.2%). Drug-related dermatologic side effects (e.g., diaper rash, pruritus, urticaria) were reported in 7.8% of cefpodoxime-treated patients and 14.5% of those who received amoxicillin-clavulanate (p = 0.160; 95% CI: -16.6%, 3.3%). Our findings suggest that clinical efficacy for cefpodoxime administered twice daily is equivalent to that of amoxicillin-clavulanate administered three times a day.

Sixty patients participated in a bacteriologically controlled, randomized, parallel group comparison of 2% mupirocin ointment (Bactroban) and oral erythromycin ethylsuccinate for the treatment of impetigo. The trial included clinical and bacteriologic evidence and safety assessments. The Investigator's Global Evaluation, which compared the overall efficacy and safety of the trial drugs, demonstrated a more favorable performance for the mupirocin regimen. This difference was statistically and clinically significant. There were no significant differences between the trial regimens for any of the other efficacy variables examined. The bacteriologic success rate was 100% for both treatment groups. There was a clinically significant difference in adverse experience rates between treatment groups, with four (13%) of the erythromycin-treated patients reporting six adverse experiences versus none of the mupirocin-treated patients. The results of the trial indicate that 2% mupirocin ointment is as safe and effective as oral erythromycin ethylsuccinate in the treatment of patients with impetigo.

Cefixime, a new third generation cephalosporin antibiotic for oral use, was evaluated for safety and efficacy in the treatment of children with acute otitis media with effusion. Fifteen United States clinical investigators participated in the multicenter clinical trial. One hundred twenty children were randomly assigned to a 10-day course of either cefixime, 8 mg/kg, given daily (qd) (60 patients) or amoxicillin, 40 mg/kg/day, administered in three divided doses (60 patients). Tympanocentesis was performed on each patient before therapy was initiated. Pathogens were isolated from a middle ear aspirate in 88% of the cases. Of the specimens from which pathogens were cultured, 33% yielded Haemophilus sp., 41% Streptococcus pneumoniae and 6% Branhamella catarrhalis. Of the 120 patients, 64 (30 cefixime and 34 amoxicillin) were evaluable for assessment of efficacy. Favorable clinical responses (cure or improvement) were obtained in 93% of cefixime-treated patients and in 94% of amoxicillin-treated patients. Overall, bacteriologic eradication rates (as determined by clinical criteria) were 94 and 95%, respectively. Clinical failure or relapse was documented in 2 of 30 (7%) patients treated with cefixime and in 2 of 34 (6%) patients treated with amoxicillin. Gastrointestinal disturbance and rash were significantly more common in children treated with cefixime (22 and 15%, respectively) than in those taking amoxicillin (8 and 2%, respectively), but in only one case was it necessary to discontinue medication because of these adverse effects (rash). Results of this study demonstrate that cefixime given once daily is as safe and effective as amoxicillin in the treatment of acute otitis media with effusion in children and has the possible advantage of less frequent dosing.

A double-blind study of 240 pediatric outpatients with acute otitis media demonstrated that cyclacillin, administered three times a day for ten days, is as effective as and better tolerated than a similar regimen of amoxicillin. Clinical success was achieved in 96% of the children treated with each drug, and the bacteriologic cure rate was 98% in each treatment group. Only three of the 119 children (2.5%) treated with cyclacillin had drug-related diarrhea, in contrast to 17/121 children (14%) treated with amoxicillin (P less than .01). This greater tolerance for cyclacillin may be due to its more effective and rapid absorption in the upper gastrointestinal tract. The results are discussed in terms of the low incidence of resistant strains of Haemophilus influenzae and the advantages of cyclacillin as the first-line treatment for acute otitis media.

A double-blind study of 134 pediatric outpatients with acute streptococcal pharyngitis demonstrated that cyclacillin, administered three times a day for ten days, is as effective as a similar regimen of amoxicillin. Clinical success was achieved in 95% of the children treated with either drug. A bacteriological cure was seen in 82% of the children evaluated in the cyclacillin group and 90% of those evaluated in the amoxicillin group. The mean time required for remission of signs and symptoms in the respective treatment groups was 3.1 and 3.0 days. Only two patients (3%) in each treatment group experienced an adverse effect of the prescribed drug.

The safety and efficacy of cefaclor were compared with amoxicillin trihydrate in the treatment of 130 cases of otitis media, and with penicillin V potassium in 88 cases of streptococcal pharyngitis in two single-blind controlled studies. Patients with otitis media received approximately 40 mg/kg/day of cefaclor or amoxicillin trihydrate for ten days to three weeks; patients with pharyngitis received 20 mg/kg/day of cefaclor or penicillin V potassium for ten days. Overall, patients who received cefaclor for otitis media had fewer acute failures and better total success, especially in cases caused by Haemophilus influenzae; however, the difference between cefaclor and amoxicillin was not statistically significant. There also was no significant difference between the clinical effectiveness of cefaclor and penicillin in the treatment of streptococcal pharyngitis. Cefaclor was well tolerated with no serious side effects.

An acellular pertussis vaccine principally containing two purified pertussis antigens, filamentous hemagglutinin and lymphocytosis-promoting factor, combined with diphtheria and tetanus toxoids was compared to conventional diphtheria-tetanus toxoids-whole cell pertussis for adverse effects and serologic responses in a group of 120 children who were from 18 to 24 months of age. Three vaccinations at 2, 4 and 6 months of age with diphtheria-tetanus toxoids-whole cell pertussis had been administered previously. Adverse effects occurred more frequently with the diphtheria-tetanus toxoids-whole cell pertussis than with diphtheria-tetanus toxoids-acellular pertussis vaccine. Fever occurred significantly more often and to a higher degree in the whole cell pertussis vaccine recipients with a peak difference occurring 6 hours after immunization (P = 0.00008). Local swelling, redness, warmth and tenderness at the injection site also occurred significantly more frequently following whole cell pertussis vaccination. No major sequelae were noted in either group. The antibody responses to lymphocytosis-promoting factor were similar for the two vaccines. The diphtheria-tetanus toxoids-acellular pertussis vaccine produced significantly lower pertussis agglutinin titers (P = 0.00001) but significantly higher antibody to filamentous hemagglutinin (P = 0.05) and to diphtheria (P = 0.03). The protective role of antibody to pertussis agglutinins vs. filamentous hemagglutinin and lymphocytosis-promoting factor continues as a central issue in the quest for a new pertussis vaccine. A clinical efficacy trial is needed.

Although topical antibiotics have been considered less than effective agents in the treatment of "impetigo," recent experience suggests that topical therapy has a place as primary treatment of pyoderma and impetigo. This bacteriologically controlled, randomized study compared the safety and efficacy of mupirocin with oral erythromycin in the treatment of pyoderma and impetigo. A total of 29 mupirocin-treated and 30 erythromycin-treated patients completed the study. None of the mupirocin-treated patients reported adverse experiences compared with 4 erythromycin-treated patients who reported 6 adverse experiences. The mupirocin-treated group had a significantly higher benefit:risk ratio than the erythromycin-treated group as measured by the investigator's global evaluation (P = 0.01). Both treatments eradicated 100% of the two most common pathogens, Staphylococcus aureus and Streptococcus pyogenes. Results from this study demonstrate that mupirocin is as effective as systemic erythromycin ethylsuccinate for treatment of pyoderma and impetigo.

A multicenter double-blind study of 363 pediatric outpatients with acute otitis media demonstrated that cyclacillin, administered in three divided doses (three times a day) for ten days, is as effective as and better tolerated than a similar regimen of amoxicillin. The bacteriologic cure rate for patients with middle-ear cultures was 98% in both treatment groups. Remission of signs and symptoms was significantly faster in the cyclacillin group (3.1 days) than in the amoxicillin group (4.3 days) (P less than 0.05). Of the 179 children treated with cyclacillin, three (1.7%) had drug-related diarrhea in contrast to 18 of the 184 (9.8%) children treated with amoxicillin (P less than 0.01). Cyclacillin produces a rapid resolution of symptoms and a low incidence of diarrhea.

The long-term effectiveness of cephradine and amoxycillin in the treatment of otitis media was evaluated in one hundred children ranging in age from 4 months to 14 years. The immediate clinical response was comparable in both treatment groups, but the recurrence rate during a 12-month follow-up period was considerably lower in the patients treated with cephradine. The incidence of side-effects was similar in the two groups.