Comparative study of the safety and efficacy of clarithromycin and amoxicillin-clavulanate in the treatment of acute otitis media in children.

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.

Pyuria and bacteriuria in urine specimens obtained by catheter from young children with fever.

Results of urinalysis and culture of 2181 urine specimens obtained by catheter from febrile children aged less than 24 months were analyzed to determine the following: (1) an optimal cutoff point in considering a bacterial colony count clinically "significant," (2) the accuracy of leukocyte esterase and nitrite tests in identification of pyuria and bacteriuria, and (3) the utility of pyuria (defined as > or = 10 leukocytes/mm3) in the discrimination of urinary tract infection from asymptomatic bacteriuria. Among 110 urine cultures with > or = 10,000 colony-forming units per milliliter, 92 (84%) had > or = 100,000 CFU/ml, 10 (9%) had 50,000 to 99,000 CFU/CFU/ml and 8 (7%) had 10,000 to 49,000 CFU/ml. Urine specimens with 1000 to 49,000 CFU/ml were more likely than specimens with > or = 50,000 CFU/ml to yield Gram-positive or mixed organisms (36/60 vs 7/109; p < 0.001). A count of < 10 leukocytes/mm3 was almost invariably associated with a sterile culture; a count of > or = 10 leukocytes/mm3 was found in 93 of 102 patients with > or = 50,000 CFU/ml. The dipstick leukocyte esterase test had sensitivities of 52.9% and 66.7% in detecting > or = 10 leukocytes/mm3 and > or = 20 leukocytes/mm3, respectively. The dipstick nitrite test had a sensitivity of 31.4% in detecting bacteriuria (> or = 50,000 CFU/ml). Acute pyelonephritis was diagnosed by a renal scan with dimercaptosuccinic acid labeled with technetium 99m in 50 (77%) of 65 patients with > or = 10 leukocytes/mm3 but in none of five patients with < 10 leukocytes/mm3 (p < 0.01). The findings in these five patients were consistent with colonization of the urinary tract rather than infection. For urine specimens obtained by catheter, we believe that urinary tract infection is best defined by both a leukocyte count > or 10/mm3 and a CFU count > or = 50,000/ml. This definition almost always discriminates among true urinary tract infection, bacteriuria resulting from contamination of the urine specimen, and asymptomatic bacteriuria.

Prevalence of urinary tract infection in febrile infants.

Urinary tract infection (UTI), a relatively common cause of fever in infancy, usually consists of pyelonephritis and may cause permanent renal damage. This study assessed (1) the prevalence of UTI in febrile infants (temperature > or = 38.3 degrees C) with differing demographic and clinical characteristics and (2) the usefulness of urinalysis in diagnosing UTI. We diagnosed UTI in 50 (5.3%) of 945 febrile infants if we found > or = 10,000 colony-forming units of a single pathogen per milliliter in a urine specimen obtained by catheterization. Prevalences were similar in (1) infants aged < or = 2 months undergoing examination for sepsis (4.6%), (2) infants aged > 2 months in whom UTI was suspected, usually because no source of fever was apparent (5.9%), and (3) infants with no suspected UTI, most of whom had other illnesses (5.1%). Female and white infants had significantly more UTIs, respectively, than male and black infants. In all, 17% of white female infants with temperature > or = 39 degrees C had UTI, significantly more (p < 0.05) than any other grouping of infants by sex, race, and temperature. Febrile infants with no apparent source of fever were twice as likely to have UTI (7.5%) as those with a possible source of fever such as otitis media (3.5%) (p = 0.02). Only 1 (1.6%) of 62 subjects with an unequivocal source of fever, such as meningitis, had UTI. As indicators of UTI, pyuria and bacteriuria had sensitivities of 54% and 86% and specificities of 96% and 63%, respectively. In infants with fever, clinicians should consider UTI a potential source and consider a urine culture as part of the diagnostic evaluation.

Intra- and interobserver variability in interpretation of DMSA scans using a set of standardized criteria.

A set of criteria was developed to standardize assessment of DMSA renal scintigraphy which were performed to evaluate children for acute pyelonephritis and renal scarring. This study was undertaken to assess intra- and interobserver variability in the interpretation of DMSA renal scintigraphy using these criteria. Renal contours and parenchyma were assessed in three zones. Contours were assessed as normal or abnormal and parenchymal defects were evaluated in terms of character, shape and degree in three regions (upper and lower pole and midzone). Two nuclear medicine physicians blindly reviewed 57 DMSA scintigraphy on two occasions each. Disagreement of each observer's evaluation of the same scintigraphy on two different occasions was described as intraobserver variability, and the comparison between readings by each of the two observers was described as interobserver variability. High levels of intra- (95.9% and 90.6% respectively, p < 0.05) and interobserver agreement (84.4%, p < 0.05) were demonstrated. There were minor differences in inconsistencies between the two kidneys or different kidney zones. We conclude that standardization of criteria resulted in higher intra- and interobserver consistency in interpretation of DMSA scintigraphy.