***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
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    ***EXAMPLES*** 
    Input: BACKGROUND Pertussis is still a prevalent public health problem , and antibiotic therapy may decrease disease severity and limit communicability . Erythromycin is the recommended antibiotic for treatment and prophylaxis of pertussis ; however , side effects of erythromycin limit its usefulness in some patients . Clarithromycin , a newer macrolide , has good in vitro activity against Bordetella pertussis and a better side effect profile . GOALS OF THE STUDY To compare the microbiologic and clinical efficacy and the clinical safety of a 7-day course of clarithromycin vs. a 14-day course of erythromycin in children with pertussis . DESIGN Prospect i ve , r and omized , single blind ( investigator ) , parallel group trial . METHODS Children from 1 month to 16 years of age presenting with a clinical ly defined pertussis syndrome were eligible for the study . After obtaining informed written consent , we r and omized patients to receive either clarithromycin ( 7.5 mg/kg/dose twice a day for 7 days ) or erythromycin ( 13.3 mg/kg/dose three times a day for 14 days ) . Nasopharyngeal cultures for B. pertussis were performed at enrollment and after end of treatment . Clinical assessment s were performed at enrollment , at end of treatment and at a 1-month follow-up visit . Adverse event data were collected throughout the study . RESULTS The  clarithromycin ( n = 76 ) and erythromycin ( n = 77 ) groups were well-matched for age and previous pertussis immunization .  Microbiologic eradication and clinical cure rates were 100 % ( 31 of 31 ) for clarithromycin and 96 % ( 22 of 23 ) for erythromycin . The clarithromycin group had significantly fewer adverse events [ 45 % ( 34 of 76 ) for clarithromycin vs. 62 % ( 48 of 77 ) for erythromycin ; P = 0.035 ] , and compliance with the medication regimen was significantly higher in these patients . CONCLUSIONS A 7-day regimen of clarithromycin and a 14-day course of erythromycin were equally effective for treatment of pertussis . Clarithromycin was better tolerated than conventional erythromycin therapy OBJECTIVE Although universal immunization against Bordetella pertussis ( whooping cough ) infection has result ed in dramatic reductions in the incidence of pertussis , outbreaks continue to occur in countries with excellent vaccine coverage . Treatment of infection may ameliorate symptom severity during the catarrhal phase of pertussis but has no effect on established paroxysms , emesis , or apnea if given during the paroxysmal or convalescent phases . Erythromycin , recommended for treatment of pertussis to prevent transmission of infection , is poorly tolerated because of gastrointestinal side effects . We compared the safety and efficacy of erythromycin with azithromycin for treatment of pertussis in a large , r and omized , controlled trial that enrolled children from primary care practice s in 1 American and 11 Canadian urban centers . METHODS Children who were 6 months to 16 years of age and had cough illness that was suspected to be or was culture confirmed as pertussis were r and omized to azithromycin ( 10 mg/kg on day 1 and 5 mg/kg on days 2 - 5 as a single dose ) or erythromycin estolate ( 40 mg/kg/day in 3 divided doses for 10 days ) with stratification by center . The primary outcome measure was bacteriologic cure of infection as determined by cultures of nasopharyngeal aspirates .  Culture-positive participants had a second aspirate collected at the end of therapy ( days 5 - 7 for azithromycin , days 10 - 12 for erythromycin ) and 1 week after therapy . Bacteriologic cure was defined as negative cultures at the end of therapy . Bacteriologic relapse was defined as a positive culture 1 week after completion of therapy and after a negative end-of-therapy culture . Secondary outcomes were pertussis diagnosed by serology and polymerase chain reaction ( PCR ) , treatment-associated adverse events , compliance , and presence of clinical symptoms at the end of the treatment course . Serology was performed using st and ard enzyme-linked immunosorbent assay methods . A participant was considered to have pertussis when the PCR was positive or a 4-fold increase in pertussis toxin antibody between baseline and follow-up visits was observed . PCR was performed using a 1046-bp ClaI DNA fragment from B pertussis . Adverse events ( nausea , vomiting , diarrhea , any gastrointestinal complaint , or other ) were determined by a parent-completed diary that was review ed with study personnel during study visits . Compliance was measured by review of the parent medication diary during study visits and observation of medication containers by the pharmacist at study completion . Symptoms were determined by history collected by study personnel at enrollment and subsequently from the diary . The design of the study was an equivalence trial , aim ed at demonstrating that the bacteriologic failure rates with the 2 therapies did not differ by > 8 % . For the safety analysis , all participants who received at least 1 dose of study drug were included . In the per- protocol efficacy analysis , all culture-positive participants with end-of-treatment cultures were considered . RESULTS A total of 477 children were enrolled and r and omly assigned to either azithromycin ( n = 239 ) or erythromycin ( n = 238 ) . Of these children , 114 ( 24 % ) grew B pertussis from nasopharyngeal specimens ( azithromycin group : 58 of 239 [ 24 % ] ; erythromycin group : 56 of 238 [ 23 % ] ) ; these children composed the efficacy cohort for the per- protocol and intention-to-treat analyses . Serology and PCR added 52 children to the number considered to have pertussis for a total of 35 % ( 166 of 477 ) of all children who presented with cough illness . In the safety analysis ( antibiotic side effects , compliance ) and comparison of cough symptoms after treatment , all r and omized children are reported in their assigned treatment group . At end of therapy , bacterial eradication was demonstrated in all 53 patients in the azithromycin group and all 53 patients in the erythromycin group with follow-up cultures available ( eradication 100 % ; 95 % confidence interval [ CI ] : 93.3 - 100 ) . No bacterial recurrence was demonstrated in children with 1 week posttreatment nasopharyngeal cultures available ( 51 and 53 participants in the azithromycin and erythromycin arms , respectively [ 0 % , 95 % CI : 0 - 7.0 ; and 0 % , 95 % CI : 0 - 6.7 ] ) . No serious adverse events attributable to study drug were observed . Gastrointestinal adverse events were reported less frequently in azithromycin ( 18.8 % ; 45 of 239 ) than in erythromycin estolate ( 41.2 % ; 98 of 238 ) recipients ( 90 % CI on difference : -29.0 % to -15.7 % ) as a result of less nausea ( 2.9 % vs 8.4 % ; 95 % CI : -8.9 % to -2.0 % ) , less vomiting ( 5.0 % vs 13.0 % ; 95 % CI : -4.9 % to -1.4 % ) , and less diarrhea ( 7.1 % vs 11.8 % ; 95 % CI : -9.0 % to -0.3 % ) . Children who were r and omized to azithromycin were much more likely to have complied with antimicrobial therapy over the treatment period . In the azithromycin group , 90 % of children took 100 % of prescribed doses , whereas only 55 % of children in the erythromycin group took 100 % of prescribed doses . CONCLUSIONS In this large , multicenter , r and omized trial , we found that azithromycin is as effective as erythromycin estolate for the treatment of pertussis in children .  Gastrointestinal adverse events were much more common with erythromycin treatment than azithromycin .  Compliance with therapy was markedly better with azithromycin than with erythromycin in this study A total of 384 children with group A beta-haemolytic streptococcal ( GABHS ) pharyngitis were r and omized to receive either 40 mg/kg/day of cefaclor in two doses for 5 days ( 192 patients ) , or 40 mg/kg/day of amoxycillin in three doses for 10 days ( 192 patients ) . The signs and symptoms of pharyngitis were recorded and throat cultures were obtained at presentation and on days 6 - 7 , 11 - 15 , 16 - 20 and 28 - 35 . Patient compliance was significantly higher in the children treated with cefaclor ( 100 vs. 95.1 % ; P = 0.003 ) . At the end of follow-up , the percentage of clinical success was 91.4 % for cefaclor and 91.9 % for amoxycillin ( P = 0.974 ) ; bacteriological success was obtained in 85.7 and 89.6 % children ( P = 0.348 ) , respectively . Both treatments were well-tolerated with adverse event rates of 8.3 % in the cefaclor group and 9.4 % in the amoxcillin group ( P = 0.857 ) . Our study shows that five days ' treatment with cefaclor  is as effective and safe as the conventional 10-day course of amoxycillin in the treatment of GABHS pharyngitis , but compliance seems to be significantly greater An investigator-blinded , r and omized , multicenter study was conducted to compare the efficacy and safety of cefdinir and amoxicillin/clavulanate ( amoxicillin/CA ) in the treatment of pediatric patients with acute suppurative otitis media . Patients 6 months to 12 years of age were r and omized in a 1:1:1 ratio to receive cefdinir 14 mg/kg once-daily , cefdinir 7 mg/kg b.i.d . , or amoxicillin/CA 13.3 mg/kg t.i.d . Test-of-cure was determined 11 to 16 days posttherapy . Of the 752 patients who entered the study , 665 ( 88 % ) completed treatment and 595 ( 79 % ) were evaluable . Response rates in the three treatment groups were similar . Overall rates of adverse events were statistically lower in the cefdinir once-daily group than in the amoxicillin/CA group . Diarrhea was the most common adverse event in all treatment groups . Cefdinir given either once-daily or twice-daily is a safe and effective treatment for pediatric patients with acute suppurative otitis media Objective . To undertake population pharmacokinetic modeling and to determine the safety and efficacy of once daily ( OD ) gentamicin dosing in children with severe urinary tract infections ( UTI ) . Methods . An open , r and omized , controlled trial comparing OD with three times daily ( TD ) gentamicin dosing in hospitalized children ages 1 month to 12 years with UTI . Daily doses ( milligrams per kg per day ) of gentamicin in both groups were 7.5 ( < 5 years old ) , 6.0 ( 5 to 10 years old ) and 4.5 ( > 10 years old ) . Results . There were 179 children enrolled ( 90 OD , 89 TD ) . Baseline clinical characteristics and pathogens were similar , except that circulatory compromise and renal cortical scintigraphic defects were more common in the OD group . Median gentamicin treatment duration s were 3.0 ( OD ) and 2.7 ( TD ) days . Mean peak gentamicin concentrations were 17.3 ( OD ) vs. 6.4 ( TD ) mg/l ; 99 % of peak concentrations were > 7 mg/l in the OD group whereas 16 % of peak concentrations were < 5 mg/l in the TD group . Mean trough concentrations were 0.35 ( OD ) vs. 0.55 ( TD ) mg/l . In the OD group 4 % of trough concentrations were ≥2 mg/l , whereas in the TD group only 0.7 % were ≥2 mg/l . Age or prior elevated peak concentrations did not predict high trough concentrations . Population pharmacokinetic modeling of the data fitted a one-compartment model with first order elimination . There were no clinical or bacteriologic failures . The two disease-related complications were confined to the OD group . No nephro- or ototoxicity was identified . Conclusions . With age-appropriate dosing and measurement of serum trough concentrations before the second dose , OD gentamicin is safe and effective for the treatment of UTI requiring parenteral treatment in children aged 1 month to 12 years Fifty-four neonates were included and completed the study . Twenty-seven neonates were given 2.0 - 2. 
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Conclusions and Relevance Overall , AEs in paediatric antibiotic CTs were predictable and class-specific , and no unexpected ( age-specific ) side effects were identified .
Smaller , open-label , dose-finding , high- quality , single-arm pharmacokinetic trials seem potentially sufficient for certain common antibiotic classes , extrapolating well-established safety profiles determined from large adult efficacy trials .
This approach could reduce duration and enhance subsequent registration of urgently needed new antibiotics .