Sulphamethoxazole prophylaxis in the otitis-prone child. Sulfisoxazole as chemoprophylaxis for recurrent otitis media. A double-blind crossover study in pediatric practice. Sulfisoxazole prophylaxis of middle ear effusion and recurrent acute otitis media. Prevention of recurrent acute otitis media: chemoprophylaxis versus tympanostomy tubes. Efficacy of antimicrobial prophylaxis and of tympanostomy tube insertion for prevention of recurrent acute otitis media: results of a randomized clinical trial. Prophylaxis for recurrent acute otitis media: a Brazilian study. Sulfisoxazole chemoprophylaxis for frequent otitis media. Efficacy of antimicrobial prophylaxis for recurrent middle ear effusion. Continuous twice daily or once daily amoxicillin prophylaxis compared with placebo for children with recurrent acute otitis media. Prophylaxis of recurrent acute otitis media and middle-ear effusion. Comparison of amoxicillin with sulfamethoxazole and trimethoprim. Chemoprophylaxis of recurrent otitis media using trimethoprim/sulfamethoxazole. Antimicrobial prophylaxis for infants at risk for recurrent acute otitis media. Prophylaxis of otitis media in asthmatic children. Otitis media in Alaskan Eskimo children. Prospective evaluation of chemoprophylaxis. Recurrent acute otitis media--prophylactic penicillin treatment: a prospective study. Part I.
A bedtime dose of sulphamethoxazole was effective in preventing ear infections in otitis-prone young children. Thirty-three such children were studied by means of a random, double-blind, placebo-controlled, cross-over protocol. Nine (27%) of 33 children treated with sulphamethoxazole experienced 10 episodes of acute suppurative otitis media or otitis media with effusion while 19 (58%) of 33 children given a placebo experienced 27 episodes of acute otitis media or otitis media with effusion. No new episode of otitis media was observed in 11 children in whom serial urine samples uniformly had a positive response to Micrococcus lutea bioinhibition test, the method we chose to monitor compliance. Otitis media with effusion (secretory otitis media) was detected less often in the children who were given sulphamethoxazole; this fact suggests that prophylaxis with sulphamethoxazole may prevent persistent middle ear effusion in otitis-prone young children. nan The efficacy of sulfisoxazole prophylaxis was evaluated in 32 otitis-prone children in a double-blind cross-over clinical trial. During the sulfisoxazole therapy, seven patients (22%) had nine episodes of acute otitis media (AOM) while 20 patients (63%) receiving placebo had 36 episodes of AOM (P = .001). Although sulfisoxazole appeared to be beneficial in patients aged 2 to 5 years, statistically significant efficacy was noted only in children under 2 years of age. Otitis media with effusion persisting for more than five weeks was observed in ten children (31%) during sulfisoxazole therapy and in 14 children (44%) during the placebo period (P greater than .975). Sulfisoxazole therefore appears effective in preventing recurrent symptomatic AOM but not in reducing the frequency of persistent otitis media with effusion. The importance of careful follow-up of children receiving long-term sulfisoxazole therapy for prevention of recurrent AOM is stressed. Otitis media has long been recognized as one of the most common diseases of childhood. Several therapeutic modalities have been advocated for the prevention of recurrent episodes of acute otitis media (AOM). A blinded, prospective, randomized study was designed to determine the efficacy of tympanostomy tubes, antibiotic prophylaxis, and placebo. Children with recurrent AOM were entered in the study and followed for at least 6 months. A total of 65 children completed the protocol. Sixty-three of those were under the age of 4 years. Treatment failure was defined as two or more episodes of AOM or otorrhea in less than 3 months. Five of 22 children in the tympanostomy tube group failed, compared to 12 of 20 in the placebo group (p = .02). There were 8 or 21 treatment failures in the sulfisoxazole group. Children with otitis media with effusion (OME) at the time of their initial visit had significantly less middle ear disease when treated with tympanostomy tubes. Tympanostomy tube insertion for prophylaxis of recurrent acute otitis is supported by these findings. Improvement of recurrent AOM was observed in the sulfisoxazole group, but was not statistically significant. To determine the efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion in preventing recurrences of acute otitis media, we randomized 264 children 7 to 35 months of age who had a history of recurrent otitis media but were free of middle ear effusion to receive either amoxicillin prophylaxis, bilateral tympanostomy tube insertion or placebo. The average rate of new episodes per child year of either acute otitis media or otorrhea was 0.60 in the amoxicillin group, 1.08 in the placebo group and 1.02 in the tympanostomy tube group (amoxicillin vs. placebo, P less than 0.001; tubes vs. placebo, P = 0.25). The average proportion of time with otitis media of any type was 10.0% in the amoxicillin group, 15.0% in the placebo group and 6.6% in the tympanostomy tube group (amoxicillin vs. placebo, P = 0.03; tubes vs. placebo, P less than 0.001). At the 2-year end point, the rate of attrition was 42.2% in the amoxicillin group, 45.5% in the placebo group and 26.7% in the tympanostomy tube group. Adverse drug reactions occurred in 7.0% of the amoxicillin group and persistent tympanic membrane perforations developed in 3.9% of the tympanostomy tube group. The observed degree of efficacy of amoxicillin prophylaxis and of tympanostomy tube insertion must be viewed in light of the fact that study subjects proved not to have been at as high risk for acute otitis media as had been anticipated and in view of the differential attrition rates.(ABSTRACT TRUNCATED AT 250 WORDS) We enrolled 60 children with recurrent acute otitis media (AOM) in a study of the effectiveness of antimicrobial prophylaxis. All children were entered into the study following an acute episode of infection treated with amoxicillin (AMX) for 10 days. Following therapy, the children were re-examined, and then randomly assigned to receive either trimethoprim-sulfamethoxazole (TMP-SMX), amoxicillin (AMX) or a placebo (PLA). Twenty children were included in each group. Each drug was administered once a day at bedtime, at 1/3 the therapeutic dose, for 3 months. Children were re-evaluated with pneumootoscopy during episodes of acute illness and with pneumootoscopy and impedance tympanometry (TYMP) at monthly intervals. We observed a significantly increased rate of recurrent AOM in children receiving placebo compared with those who received antibiotics (50% vs. 17% P < 0.005). Both prophylactic antibiotics were equally effective in preventing recurrent AOM (recurrence rate 20% TMP-SMX, 15% AMX). We also observed that recurrences in children receiving placebo occurred earlier in the study period than in those receiving antibiotics. These results suggest that antimicrobial prophylaxis in children with recurrent acute otitis media is effective in reducing subsequent disease. The similar efficacy of both antibiotics tested suggests that the less expensive agent should be used. Sulfisoxazole, 75 mg/kg/d in two divided doses for 3 months, was administered in a double-blind placebo crossover study to 35 children aged 6 months to 5 years who had frequent recurring episodes of otitis media. There was a 40% reduction in the rate of otitis media among patients receiving sulfisoxazole compared with those receiving placebo (0.25 v 0.42 episode per patient-month) which did not depend on age, sex, season, or several other factors. Using a randomized order, among patients who received placebo first, there was a 64% reduction on sulfisoxazole therapy compared with placebo (0.20 v 0.56 episode per patient-month). In this subgroup, there was significant improvement in eustachian tube function according to serial tympanograms. In the patients who received sulfisoxazole first, the rate of acute otitis remained low on placebo (0.28 v 0.30 episode per patient-month), and tympanogram patterns continued to improve after discontinuation of the active drug. These differences suggest a carry-over effect from the benefits of chemoprophylaxis. There was no significant difference in the species or sensitivity patterns of bacteria isolated from patients receiving sulisoxazole or placebo. Sulfisoxazole chemoprophylaxis appears to be safe and effective in significantly reducing episodes of otitis media and improving tympanogram patterns. This trial compared the efficacy of amoxicillin prophylaxis with that of placebo for the management of recurrent middle ear effusion (MEE) in children.
                Children between 7 months and 12 years of age who were effusion-free at entry but had histories of chronic or recurrent MEE were randomly assigned to receive either amoxicillin (20 mg/kg once daily) or placebo for 1 year. They were examined monthly and when there were symptoms of ear, nose or throat disease. Acute otitis media (AOM) and new episodes of otitis media with effusion (OME) were treated with amoxicillin-clavulanate; tympanocentesis was performed when possible for episodes of AOM. Throat cultures were obtained at entry; 4, 8 and 12 months after entry; and with new episodes of AOM and OME. Tympanometry was performed at each visit and audiometry was performed at entry and 4, 8 and 12 months after entry.
                One hundred eleven children were entered in this study. The rates per person year of new episodes of disease in the amoxicillin and placebo groups, respectively, were: MEE, 1.81 vs. 3.18 (P < 0.001); AOM, 0.28 vs. 1.04 (P < 0.001); and OME, 1.53 vs. 2.15 (P = 0.016). Subjects in the amoxicillin group had less time with MEE than the placebo group (19.7 and 33.2%, respectively; P = 0.002). Middle ear and throat cultures did not reveal any increase in beta-lactamase-producing organisms or in Streptococcus pneumoniae attributable to daily use of amoxicillin.
                Amoxicillin prophylaxis lowered the rates of occurrence of MEE, AOM and OME and decreased the percentage of time with MEE. However, because of present day concerns regarding antibiotic resistance, management should be individualized. To determine the effectiveness of amoxicillin administered continuously twice daily vs. once daily vs. placebo to prevent new episodes of acute otitis media (AOM).
                Randomized, double blind, placebo-controlled clinical trial at a hospital-based general pediatric clinic and a private pediatric practice, both in Denver, CO.
                One hundred ninety-four children (age 3 months through 6 years) were enrolled with 3 documented AOM episodes within the prior 6 months, without ventilating tubes or associated anatomic defects, immunodeficiency disorders or allergy to penicillin. Thirty-six were noncompliant and were excluded from the study, leaving 158 evaluable subjects.
                The amoxicillin dosage was 20 mg/kg/day either bid or qd. After randomization to placebo twice daily (bid), amoxicillin once daily (qd)/placebo qd or amoxicillin bid, patients were followed monthly and were also seen for upper respiratory infection symptoms during enrollment in the trial. Development of two new AOM episodes terminated the patients from the study.
                Incidence density (ID) measurements were calculated for all study subjects and were stratified by age and season. Overall study subjects in all 3 arms of the trial had 7243 days at risk during which time they developed 56 new AOM episodes for a annual ID of 2.82. There were no significant differences in the IDs between amoxicillin qd vs. bid or amoxicillin (bid or qd) vs. placebo. After stratifying by age and season of enrollment, there were no significant differences in ID rates among the 3 groups. The proportion of subjects remaining otitis-free was 63% for the placebo group, 64% for once daily amoxicillin and 61% for twice daily amoxicillin.
                While once-a-day dosing was equivalent to twice-a-day dosing for amoxicillin prophylaxis, there was no benefit of amoxicillin prophylaxis compared with a placebo control in preventing new AOM episodes. Because of the potential of excessive antibiotic use to promote the acquisition of resistant pneumococci and the lack of effectiveness in this trial, routine use of amoxicillin prophylaxis should be discouraged. We compared the efficacy of amoxicillin with that of the combination drug sulfamethoxazole and trimethoprim in reducing recurrences of acute otitis media (AOM) in a single-blind, randomized, placebo-controlled trial involving 96 children. Each of the children had had three or more episodes of AOM in the preceding 6 months, and 97% (93/96) of them still had unilateral or bilateral effusion at the beginning of the study. During the 6-month study period, 9 (27%) of 33 of the children in the amoxicillin group developed 9 episodes of AOM, 9 (27%) of 33 of the children in the sulfamethoxazole and trimethoprim group experienced 11 episodes of AOM, and 19 (63%) of 30 of the children in the placebo group developed 25 episodes. Young age and day-care attendance characterized children for whom prophylaxis was more efficacious. Overall persistence of middle-ear effusion was shorter in treated children only as a consequence of the reduced number of new episodes of AOM. This study was undertaken during the late fall, winter, and early spring months to determine the efficacy of daily trimethoprim/sulfamethoxazole (TMP/SMX) administration in the prevention of recurrent acute otitis media (RAOM) in a specific high-risk pediatric population. Twenty-one ambulatory patients, 10 in the study group and 11 in the control group, were selected from a medical university clinic and a local private practice. The study group receiving prophylactic therapy for six months suffered no recurrences, as compared with eight children suffering one recurrence each in the control group that was treated only acutely. The results were significant at p less than 0.005 with df = 1, determined by the Fischer's exact test and the chi-square method using Yates's correction factor. These data indicated that a mean dose of TMP/SMX 6.8/34 mg/kg/d divided into twice daily doses and given for six months was safe and effective in controlling RAOM infections in a high-risk pediatric population. nan Seventy-two asthmatic children with recurrent otitis media were studied over a 2-year interval. They were randomly divided to receive either (1) no routine medication, (2) antihistamines whenever nasally congested, (3) daily sulfisoxazole at 500 mg twice a day, (4) pneumococcal immunization and (5) both pneumococcal vaccine and 500 mg sulfisoxazole twice daily. There was no apparent benefit in the antihistamine group. There was a mean yearly reduction in otitis media of 75% in the sulfisoxazole group, 38% in the pneumococcal vaccine group and 90% in the group treated with both agents. The latter group also had a 56% reduction in frequency of acute asthmatic attacks and a 90% decrease in hospitalizations associated with otitis media. In conclusion the use of sulfisoxazole and pneumococcal vaccine appears efficacious for management of asthmatic children with recurrent otitis media. nan Recurrent acute otitis media (RAOM) is a distressing clinical manifestation of middle ear pathology, mainly expressed in the first two years of life. In this controlled study, prophylactic treatment by phenoxymethyl penicillin reduced significantly the frequency of RAOM in 60 children, as compared to 48 children who received a short ampicillin course only on the occasion of an acute otitis media episode. The importance of breastfeeding, age at initial episode, the type of treatment given and the pertinent literature is discussed. A working hypothesis of this prophylactic treatment is suggested.
For children at risk, antibiotics given once or twice daily will reduce the probability of AOM while the child is on treatment. In similar populations, antibiotics will reduce the number of episodes of AOM per year from around three to around 1.5. We believe that larger absolute benefits are likely in high-risk children. These conclusions were not affected by sensitivity analyses.