Ambulatory management of pediatric asthma.

Asthma is the most common chronic inflammatory disease of childhood. While specialists should care for the most severe individuals with this disease, the bulk of pediatric asthma care rests in the hands of the primary care physician. This Article details information that should be incorporated into the evaluation and management of the pediatric asthma patient in the ambulatory setting. Through the adoption of proper assessment and monitoring techniques in conjunction with optimal treatment strategies, our pediatric asthma patients should be able to attain the quality of life that all children deserve.

Penetration of clarithromycin into middle ear fluid of children with acute otitis media.

OBJECTIVE: To determine the steady state plasma and middle ear fluid concentrations of clarithromycin and its metabolite, 14(R)-hydroxyclarithromycin in 32 pediatric patients with acute otitis media. METHODS: After the sixth dose of a 7.5-mg/kg every-12-h regimen of clarithromycin suspension, tympanocentesis was performed at 2, 4, 8 or 12 hours postdose. Plasma and middle ear fluid samples were assayed for concentrations of clarithromycin and its 14-hydroxy metabolite. RESULTS: Mean middle ear fluid concentrations ranged from 3.0 to 8.3 micrograms/g during the dosing interval for clarithromycin and from 1.5 to 3.8 micrograms/g for 14(R)-hydroxyclarithromycin. The mean middle ear fluid concentrations were consistently greater than corresponding mean plasma concentrations, which ranged from 0.7 to 3.4 micrograms/ml for clarithromycin and from 0.8 to 1.8 micrograms/ml for 14(R)-hydroxyclarithromycin. The ratios of middle ear fluid to plasma concentration appeared to increase during the dosing interval and were 8.8 and 3.8 for clarithromycin and 14(R)-hydroxyclarithromycin, respectively, 12 h after dosing. CONCLUSIONS: Multiple oral doses of clarithromycin suspension produced sustained middle ear fluid concentrations of clarithromycin and 14(R)-hydroxyclarithromycin which exceed the minimum inhibitory concentrations of most otic pathogens.

Pediatric clinical clerkships are associated with an excess risk of acute infection.

OBJECTIVE: To determine the incidence of acute respiratory and gastrointestinal tract illness and associated absence by third-year medical students during pediatric and nonpediatric (control) clinical clerkships. DESIGN: A self-administered questionnaire was completed by students after the first 4 weeks of two pediatric clerkships (inpatient and outpatient) and two non-pediatric clerkships (obstetrics-gynecology and psychiatry). Information was obtained on the symptoms of acute respiratory and gastrointestinal tract illness and related absences. ANALYSIS: Results from each student's pediatric clerkship were compared with the results from the same student's control clerkship by means of matched-pair analysis. SUBJECTS: Students who made up the junior class at the University of Texas Southwestern Medical School at Dallas, July 1, 1990, to June 30, 1991. RESULTS: Of 177 students (77%) who completed questionnaires after one pediatric and one control clerkship, 108 students (61%) had had an acute illness while on pediatric clerkships in contrast to 69 students (39%) on control clerkships (odds ratio, 3.3; 95% confidence interval, 2.0 to 5.4; P < .001). More students were absent for illness during pediatric than control clerkships (23 [13%] vs nine [5%], respectively; odds ratio, 2.7; 95% confidence interval, 1.2 to 6.2; P = .02). The higher risk of illness during pediatric clerkships was not related to the order of the pediatric or control clerkship, the order of inpatient and outpatient pediatrics, or the season of the year. CONCLUSION: Pediatric clinical clerkships in the third year of medical school were associated with excess morbidity from acute infectious illness. Studies are needed to determine whether emphasizing infection control practices decrease this morbidity and any resulting nosocomial spread to patients.

Clarithromycin and cefaclor suspensions in the treatment of acute otitis media in children.

The safety and efficacy of a new oral suspension formulation of clarithromycin were evaluated in this multicenter, Phase III, single blind, comparative trial in 379 children ages 6 months to 12 years with signs or symptoms of acute otitis media. Children were randomized to receive a 10-day course of clarithromycin oral suspension (7.5 mg/kg; maximum, 500 mg) or cefaclor oral suspension (20 mg/kg; maximum, 500 mg) twice daily. Specific clinical response criteria were developed based on pretreatment signs and symptoms and results of tympanometry. Of the 379 enrolled patients 281 (74%) were evaluable (clarithromycin, 150; cefaclor, 131). There were no demographic differences between the two groups. Fifty percent of the patients had 2 to 4 episodes of otitis media (including the current episode) in the past 12 months; 63% of the patients had an infection of moderate severity. Clarithromycin and cefaclor suspensions were similarly effective for the treatment of acute otitis media. Clinical success (cure, cure with effusion or improvement) was achieved in 86% of clarithromycin-treated patients and 90% of cefaclor-treated patients. The majority of bacterial isolates for which susceptibility results were available were fully or moderately susceptible to the study drugs (96% clarithromycin, 92% cefaclor). Both drugs were well-tolerated; adverse events considered probably study drug-related were reported by 30 (15%) of clarithromycin recipients and 31 (17%) of cefaclor recipients. There were no significant differences between the groups in the numbers of patients reporting events that were thought to be related to study medication.(ABSTRACT TRUNCATED AT 250 WORDS)

Pharmacokinetics of a clarithromycin suspension in infants and children.

The single- and multiple-dose pharmacokinetics of clarithromycin and its 14-(R)-hydroxylated metabolite in infants and children were studied after oral administration under fasting and nonfasting conditions. Drug absorption appeared to be rapid following a brief delay in its onset; the mean peak concentrations in plasma (Cmax) for clarithromycin were reached within about 3 h under both conditions. The mean Cmax for the parent drug were 3.59 and 4.58 micrograms/ml in single-dose fasting and nonfasting patients, and the respective Cmax for the metabolite were 1.19 and 1.26 micrograms/ml. Data indicate good absorption and no significant effects by food. There was no unusual accumulation in the area under the concentration-time curve and Cmax in the multiple-dose group.

Urine screen for bacteriuria in symptomatic pediatric outpatients.

A retrospective review of 1019 symptomatic pediatric outpatients compared urine dipstick including leukocyte esterase and nitrite to semiquantitative Gram-stained smear of uncentrifuged urine for the identification of specimens that contained greater than or equal to 10(5) organisms/ml as determined by semiquantitative urine cultures. The Gram-stained smear was slightly more sensitive than the dipstick; 97.6% (any microorganisms seen or greater than or equal to 2 organisms/oil immersion field) vs. 90.2% (either leukocyte esterase- or nitrite-positive). The negative predictive value of both screening methods was excellent (99.9 and 99.6%, respectively). The predictive value of a positive screen was low for both methods although the predictive value of a positive screen of the Gram-stained smear did reach 63% when there were greater than or equal to 5 organisms/oil immersion field. Neither method of urine screen should substitute for a urine culture in the symptomatic outpatient. However, the urine dipstick test is a reasonable alternative to a Gram-stained smear for initial patient assessment.

Comparative evaluation of loracarbef and amoxicillin-clavulanate for acute otitis media.

One hundred five infants and children with acute otitis media were randomized to therapy with loracarbef, an experimental carbacephem antibiotic, or amoxicillin-clavulanate (Augmentin), an approved drug for this disease. Ninety-two were evaluable (46 in each group). Middle ear fluid samples obtained for culture before therapy grew Haemophilus spp. in 30% of cases, pneumococci in 29% of cases, and Moraxella catarrhalis in 15% of cases. beta-Lactamase-producing bacteria were found in 37% of patients. Clinical failure occurred in four loracarbef-treated patients and one amoxicillin-clavulanate-treated patient (P = 0.361). Recurrence of acute otitis media was more common in the 2 to 3 weeks after loracarbef treatment (eight patients) than it was after amoxicillin-clavulanate therapy (three patients), but not significantly so (P = 0.197). Thus, combined failure and recurrence occurred in 12 loracarbef-treated patients and four amoxicillin-clavulanate-treated patients (P = 0.052). Gastrointestinal side effects occurred in 13 loracarbef-treated and 21 amoxicillin-clavulanate-treated patients (P = 0.13). Diaper rash was more common with amoxicillin-clavulanate (22 patients) than with loracarbef (10 patients; P = 0.016). Satisfactory results were achieved with both antibiotics, and adverse effects, although common, were minor.

Immunogenicity of four Haemophilus influenzae type b conjugate vaccines in 17- to 19-month-old children.

OBJECTIVE: To compare the immunogenicity of four Haemophilus influenzae type b (Hib) conjugate vaccines in different populations of 17- to 19-month-old children in the United States. DESIGN: Four immunogenicity trials with sera were assayed in one laboratory. Trials 1 and 2 each compared one vaccine in two regions, and trials 3 and 4 were randomized comparisons of multiple vaccines within a region. SUBJECTS: A convenience sample of 313 healthy children recruited from pediatric practices in Minneapolis, Minn., Dallas and Houston, Tex., and Sellersville, Pa. MEASUREMENTS AND RESULTS: Children with prevaccination antibody greater than 0.15 microgram/ml showed higher antibody responses to vaccination than children with less than or equal to 0.15 microgram/ml (p less than 0.001). Among the former, there were no significant differences in antibody response to vaccination with the different conjugates within any of the trials. Among children with less than or equal to 0.15 microgram/ml of antibody before vaccination, there were no significant differences in the geometric mean antibody responses of children in trial 1 vaccinated with polyribosylribitol phosphate-diphtheria toxoid (PRP-D) in Dallas or in Minneapolis, or of children in trial 3 in Dallas randomly assigned to receive Hib oligosaccharide-CRM197 (HbOC) or PRP-D. In contrast, in trial 2, children given PRP-tetanus toxoid (PRP-T) in Pennsylvania had a significantly higher geometric mean antibody response than children given PRP-T in Houston (13.5 vs 3.0 micrograms/ml; p = 0.005). In trial 4 in Minneapolis, the geometric mean antibody response was highest in children randomly assigned to receive PRP-outer membrane protein (OMP) (9.3 micrograms/ml), followed by PRP-D (5.0 micrograms/ml) and HbOC (2.3 micrograms/ml) (PRP-OMP vs HbOC; p = 0.005). In all four trials, IgG1 responses predominated compared with IgG2 responses. CONCLUSIONS: All four conjugate vaccines are immunogenic in children 17 to 19 months of age. However, the magnitude of the anticapsular antibody response varied by vaccine type, the level of antibody in prevaccination sera, and geographic location.

Pertussis in hospitalized children.

Before the whole-cell pertussis vaccine was available, Bordetella pertussis infections were an important cause of morbidity and mortality in infants. To determine the extent of continuing morbidity in an era of vaccination, a retrospective review was conducted of the records of neonates and infants hospitalized with pertussis infection at Parkland Memorial Hospital and Children's Medical Center, Dallas, Tex. During the 20 years from 1967 through 1986, 182 patients were younger than 24 months. Among 176 patients whose immunization history was recorded, 89% had received fewer than two doses of pertussis vaccine. The mean hospital stay was 7.4 days (range, 1 to 69 days). A convulsion occurred in 11 patients (6%). Apnea was reported in 45 patients (25%) and observed in the hospital in 26 (14%). Nine patients (5%) received mechanical ventilatory therapy. Intensive care monitoring was required in 18 patients (10%). Three (1.6%) died, all with secondary bacterial pneumonia. This hospital-based population indicates that pertussis continues to be a cause of serious morbidity and mortality in infants.

Randomized controlled trial of intralesional corticosteroid and griseofulvin vs. griseofulvin alone for treatment of kerion.

We studied 30 children with tinea capitis and kerion to define the epidemiology of the disease and to compare the efficacy of intralesional steroid injection and griseofulvin to griseofulvin alone for treatment of this disorder. Patients ranged in age from 1 year to 12 years, 1 month (mean, 5 years, 7 months). All patients were black and 23 (77%) were female. (The racial composition of our clinic population is 45% black, 18% Latin American, 34% Caucasian and 3% Asian.) Fungus cultures were positive in all but one patient and Trichophyton tonsurans was isolated from 26 of 30 (87%) of the pretreatment hair cultures. Direct microscopic examinations of KOH-treated hair samples were negative in 13 of 29 (43%) culture-positive patients. Patients were randomly assigned to receive intralesional steroid injection (2.5 mg) and griseofulvin (14 patients) or griseofulvin only (16 patients). The treatment groups were comparable with regard to age, sex, duration of lesions before treatment and type of lesions. There were no significant differences between the two treatment groups in the time to negative culture, time of onset of new hair growth, complete regrowth of hair and time to scalp clearing. We conclude that intralesional injection of corticosteroid is an unnecessary adjunct to therapy for patients with tinea capitis with kerion.

Epidemiology and treatment of tinea capitis: ketoconazole vs. griseofulvin.

We studied 80 children with tinea capitis without kerion to define the epidemiology and clinical characteristics of tinea capitis and to compare the therapeutic efficacy of griseofulvin and ketoconazole for treatment of this disorder. Patients ranged in age from 2.1 to 11 years (median, 5.2 years). Trichophyton tonsurans (74%), Microsporum canis (13.5%) and Trichophyton mentagrophytes (2.7%) accounted for 90% of the infections. Pretreatment KOH slide preparations were positive in 69% of patients with alopecia and in only 29% of those with diffuse scale with little hair loss. Sixty-three patients were randomly assigned to receive ketoconazole (5 mg/kg/day) or griseofulvin (15 mg/kg/day). The treatment groups were comparable with regard to age, sex, duration of lesions prior to treatment and type of lesions. The percent of patients with positive cultures on therapy at 4, 6, 8, and 10 weeks and the mean time to a sterile culture were significantly larger (P less than 0.01) in ketoconazole (8 weeks) than in griseofulvin-treated (4 weeks) patients. The time for complete scalp clearing was significantly longer in patients who received ketoconazole (median, 108 days) compared with those who were treated with griseofulvin (median, 60 days) (P = 0.01).