Acute otitis media in pediatrics: are there rational issues for empiric therapy?

BACKGROUND: Acute otitis media in children is a significant clinical problem that requires a rational approach to treatment. The condition is extremely common and has important economic implications. At present there is considerable controversy over the most appropriate strategy and over the use and choice of antibiotics. OBJECTIVES: To analyze the various factors that influence therapeutic decisions and consider how these may assist in the formulation of a rational approach to therapy. DISCUSSION: Otitis media has a multifactorial etiology but it is extremely difficult to differentiate between bacterial and viral causes on clinical grounds. Culture of the middle ear fluid is rarely practicable; however, nasal swabs are relatively noninvasive and can provide useful microbiologic information, especially in excluding a bacterial cause. Published information provides little guidance on the most appropriate therapy; a rational approach to treatment is based on many considerations including the local epidemiology. The minimum criteria for the empiric choice of an antibiotic for acute otitis media are that it should be rapidly bactericidal and reach adequate concentrations in the middle ear fluid. In areas where beta-lactamase-producing strains are prevalent, a beta-lactamase-stable antibiotic should be chosen; good absorption from the gastrointestinal tract and high and consistent penetration into the middle ear are important characteristics. Compliance-enhancing factors such as fewer doses per day and good palatability are also important.

Short course therapy with cefitbuten versus azithromycin in pediatric streptococcal pharyngitis.

OBJECTIVE: To compare the safety and efficacy of a short course (5 days) of ceftibuten vs. azithromycin for 3 days for treatment of group A beta-hemolytic streptococcal (GABHS) pharyngitis in children. METHODS: A multicenter, open label, prospective, randomized trial in which patients > or =3 to < or =16 years of age with proven GABHS pharyngitis were randomized to receive either once daily ceftibuten for 5 days or azithromycin for 3 days. Patients were evaluated for clinical outcomes and/or for adverse events at days 6 to 8, 13 to 15 and 33 to 35 posttherapy. Microbiologic assessments (pharyngeal cultures) were conducted at baseline and at each follow-up visit. RESULTS: A total of 132 patients in the ceftibuten arm and 116 in the azithromycin arm were enrolled in the safety analysis, whereas 126 and 101, respectively, were enrolled for ceftibuten and azithromycin efficacy evaluation. Clinical success (cure or marked amelioration) at days 6 to 8 was recorded in 98 and 94% in the 2 groups, respectively. In the bacteriologic efficacy analysis at 6 to 8 days, the GABHS strain was eradicated in 76% of the patients treated with ceftibuten and in 76% of those receiving azithromycin. At 33 to 35 days, 84% of the patients in the ceftibuten arm and 71% in the azithromycin arm were GABHS-negative, and bacteriologic relapse was observed in 4 and 7% of the ceftibuten and azithromycin cases, respectively. Both treatments were well-tolerated by all patients. CONCLUSIONS: Ceftibuten and azithromycin allow simple treatment schedules (i.e. once daily administration, short duration of treatment). The somewhat higher eradication rate recorded after ceftibuten administration is consistent with the overall superior bactericidal activity of beta-lactams compared with macrolides vs. GABHS in vitro.

Clinical and pharmacological evaluation of a modified cefotaxime bid regimen versus traditional tid in pediatric lower respiratory tract infections.

It is generally accepted that the treatment of community-acquired pneumonia, either in adults or in pediatric patients, is mainly empirical. Thus, the treatment selection must fulfill both the epidemiological requirements, according to the most frequently described pathogens, and the pharmacological criteria to ensure adequate and prolonged drug concentrations at the infection site, to reach clinical efficacy. Cefotaxime has proven to be effective in this indication when traditionally administered three times daily and, more recently, twice daily, as a result of a re-evaluation of its pharmacokinetic/pharmacodynamic features. To gain further evidence using this updated dosing schedule, 258 pediatric patients with lower respiratory tract infections were treated with cefotaxime 100 mg/kg/day, administered as a twice daily or three times daily regimen. In the cefotaxime 50 mg/kg twice-daily group (n = 130), a complete resolution of clinical signs and symptoms were observed in 88.5% of patients. Similarly, in the cefotaxime 33.3 mg/kg group (n = 128), 93.6% of patients had a complete resolution of clinical signs and symptoms. Both drug schedules were well tolerated. Pharmacokinetic parameters determined for the two cefotaxime dosing schedules showed comparability. The serum half-life of desacetylcefotaxime was marginally longer than for cefotaxime in both dosage groups (1.64 and 1.36 h for desacetylcefotaxime versus 1.2 and 0.85 h for cefotaxime after 50 mg/kg or 33.3 mg/kg doses, respectively). Results from this study support the use of twice-daily cefotaxime administration for the treatment of lower respiratory tract infections in pediatric patients.

Efficacy and tolerability of brodimoprim in pediatric infections.

Brodimoprim is a long acting broad spectrum antibacterial agent. It is a new selective inhibitor of bacterial dihydrofolate reductase, structurally related to trimethoprim. The aim of the present study was to investigate the efficacy and tolerability of brodimoprim (10 mg/kg on the first day, 5 mg/kg/die onward) in the treatment of upper respiratory tract infections in children (age range: 2-14 years). This open group comparative study was performed either in 68 children affected by bacterial pharyngotonsillitis (37 treated with brodimoprim, 31 with erythromycin 560 mg/kg/8 hours) or in 50 patients affected by otitis media (25 treated with brodimoprim, 25 with amoxicillin/clavulanic acid 50 mg/kg/12 hours) or in 52 patients affected by acute sinusitis (25 treated with brodimoprim, 27 with amoxicillin/clavulanic acid 50 mg/kg/12 hours). All patients were clinically evaluated before admission, during the trial and 48 hours after the last dose of antibiotic. At the same time blood and secretion samples were collected for hematology/biochemistry and microbiological assays. A total of 170 subjects were treated and 141 patients demonstrated a clinical recovery/improvement following the treatment period, with approximately the same recovery rate (83%) among the groups. The bacteriological response was evaluated in 169 subjects. Eradication of pathogens was documented in 27 subjects treated with brodimoprim and 28 with erythromycin in the pharyngotonsillitis group, in 22 subjects treated with brodimoprim and 16 with amoxicillin/clavulanic acid in the otitis group and in 17 subjects treated with brodimoprim and 20 with amoxicillin/clavulanic acid in the sinusitis group. The overall eradication in brodimoprim treated patients was 77% in comparison with 76% of eradication obtained in the control groups.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical and microbiological evaluation of miocamycin activity against group A beta-hemolytic streptococci in pediatric patients. Three years' incidence of erythromycin-resistant group A streptococci.

The authors have evaluated the incidence of Group A streptococci, and the prevalence of erythromycin-resistant strains in the years 1985/86/87 at the I.C.P. of Milan. The minimum inhibitory concentrations (MICs) for erythromycin, penicillin and miocamycin of 40 erythromycin-resistant strains were also studied (MIC50-MIC90 = 4.5-8, 0.015-0.015, 0.041-0.186 micrograms/ml respectively). A clinical trial with miocamycin vs. erythromycin in the elimination of Group A streptococci (67 patients) showed good and comparable efficacy for both the antibiotics.

A double-blind clinical comparison of two dosage schedules of cefatrizine in children.

A double-blind, randomized clinical trial was carried out to compare the effectiveness of twice daily versus once daily administration of the cephalosporin, cefatrizine, in paediatric outpatients with bacterial infection of the respiratory tract. Thirty children were studied, aged 7 years 2 months (range, 4-12 years). They were given 75 mg/kg.day cefatrizine either once daily or twice daily at 12 h intervals for 8 days. Fever, clinical symptoms, bacterial eradication and overall tolerance were evaluated. No significant differences were observed between once daily or twice daily administration. This is in agreement with other studies carried out on adults. It is concluded that cefatrizine may be given to paediatric out-patients for the treatment of bacterial infection of the respiratory tract only once daily with good clinical and overall results.

[Moraxella catarrhalis: an emerging respiratory pathogen]. / Moraxella (Branhamella) catarrhalis: un patogeno respiratorio emergente.

In the past years Moraxella (Branhamella) catarrhalis has finally gained respect as a pathogen thanks to the many reports of its causal role. The intent of this review is to provide a critical evaluation of the intent of this review is to provide a critical evaluation of the microbiological features (taxonomy, diagnosis, virulence, epidemiology and drug resistance), clinical diseases and therapy of this microorganism

[Juvenile intestinal polyposis. Importance of the endoscopic diagnostic contribution]. / Poliposi intestinale giovanile. Importanza del contributo diagnostico endoscopico.

We describe three cases of juvenile intestinal polyposis in children aged 9-13 years. Ulcerative colitis in two of them and Crohn's disease in one of them were initially diagnosed. These subjects came to us for symptom persistence in spite of medical (sulfasalazine and or corticosteroids) and dietetic therapy. Further an appropriate investigations were therefore necessary; endoscopy and histological study of the specimen drawn by fibroscopy were decisive for the diagnosis. The accuracy of the endoscopy is of valuable help in uncertain situations as in those described.

[Chronic gastritis in childhood. A possible cause of recurrent abdominal pain]. / Gastrite cronica in età pediatrica. Una possibile causa di dolore addominale ricorrente.

The peptic disease is not the commonest cause of recurrent abdominal pain, among the organic aetiology. Only recently the gastric disease as cause of abdominal pain has been described in pediatric age. We have studied 11 children aged 6 to 12 years, who were examined for recurrent abdominal pain. We found that this symptom was due to chronic gastritis. We have valued these patients on the basis of the clinical manifestations, endoscopic and biopsy findings. A family history of peptic disease was found to be highly significant. We can therefore consider the gastritis as a possible organic aetiology of recurrent abdominal pain after ruling out any other organic causes.

[Treatment of hemophilia in children]. / Il trattamento dell'emofilia in età pediatrica.

Thanks to recent developments and evolution in prenatal diagnosis and early onset within the first year of life, hemophilia may now be considered a pathology of primarily pediatric interest. The treatment of hemophilia in children has furthermore undergone a number of changes that include 2 main events in therapy that have served to modify the quality of life of the hemophiliac. The first of these events regards blood products and the prevention of viral infections, hepatitis and HIV transmission. Prevention is based on various factors which include: donor selection, immunization, product testing and heat treatment of blood products. The second extremely important aspect of treatment in hemophilia is the concept of global assistance, which includes: the treatment of the bleeding episode itself, and an ongoing psycho-social support system. In this paper we suggest some practical treatment schedules for the therapy of bleeding episodes in addition to examining the severe side effects of HIV and Hepatitis viruses. The message which our paper attempts to transmit is that the hemophilic child must be ideally assisted in an exclusively pediatric environment.

[Treatment of iron deficiency in infancy with iron-acetyl transferrin]. / II trattamento della carenza marziale delle prime epoche di vita con ferro-acetil-transferrina.

In twenty eight patients with iron deficiency the efficacy of iron-acetil-transferrin treatment (2-3 mg/kg/die) has been evaluated from the changes of the following variables: RBC and reticulocyte count, Hb concentration, MCV, MCH, serum ferritin, serum iron, TIBC, and ZnPP. These variables were assessed before and after three months of treatment in all patients, and after three months from the end of the treatment in thirteen patients. At the end of the treatment there was a significant increase of RBC count, Hb concentration, MCV, MCH, serum ferritin, serum iron, and TIBC, a significant decrease of ZnPP, while reticulocyte count remained essentially unchanged. After three months from the end of the treatment only serum ferritin and ZnPP underwent an additional significant increase and decrease, respectively. In twenty-six patients serum ferritin values returned to normal. The changes of RBC and reticulocyte count, Hb concentration, MCV, serum iron, and TIBC were larger the lower the initial values, suggesting that the efficacy of the treatment is greater the more serious the iron deficiency.

[Sudden infant death syndrome in Italy. A multidisciplinary approach]. / La sindrome della morte improvvisa del lattante in Italia. Un approccio multidisciplinare.

A Center for the Sudden Infant Death Syndrome has been established in 1981. Active research involves clinical prospective studies and basic research, mostly aimed at testing our cardiac theory for SIDS. The bereaved families enter in a follow-up program with specific psychological support. At risk babies are evaluated for cardio-respiratory abnormalities and repeatedly controlled. Parents of victims are in the process of forming a group with the objective to support and inform the families of new victims. This is the first attempt to approach systematically the SIDS problem in Italy.

[Validity of the H2 breath test and limits of blood xylose in the evaluation of malabsorption in children]. / Validità del breath H2 test e limiti della xilosemia nella valutazione del malassorbimento in età pediatrica.

Many authors have recently discussed the real value of the xylose test in the evaluation of intestinal malabsorption, especially its correlation with the morphological damage of the duodenal-jejunal mucosa. In our study we have performed in 48 pediatric patients one-hour blood xylose test and breath H2 test, method used for the diagnosis of sugar malabsorption, in order to value small bowel function and to know indirectly small intestinal mucosal structure. We have compared the values of the xylose test with those of the breath H2 test and both with hystological findings. The D-xylose absorption test was performed using the technique described by Roe and Rice. A serum concentration of more than 25 mg/dl was considered normal. For the breath H2 test the technique described by Douwes was used. A hydrogen concentration lower than 20 p.p.m. in expired air was considered normal. All of the patients in whose breath hydrogen was not detected after lactose oral load (2g/Kg body-weight, maximum 50 g), underwent a second test with lactulose (0,8 - 1 g/Kg body-weight), is not absorbed. We performed this test to rule out a false negative result (2% of the normal population). On histologic criteria, the patients were assigned to one of three study groups. Group I: normal duodenal-jejunal mucosal structure (11 patients). Group II: structural abnormalities not diagnostic of celiac diseases (7 patients). Group III: mucosal structural abnormalities typical of celiac disease (30 patients). In the first group the one-hour blood xylose test was normal in 9 patients (81.81%), whilst the breath H2 test was normal in 11 patients (100%).(ABSTRACT TRUNCATED AT 250 WORDS)

[Gastrointestinal fiber endoscopy in children: diagnostic and therapeutic contribution]. / La fibroendoscopia digestiva in età pediatrica: contributo diagnostico e terapeutico.

The diagnostic and therapeutic value of gastrointestinal endoscopy in adults is well established. Our study, performed in pediatric patients confirms its usefulness and emphasises its easy execution and little risk in children. The availability of small caliber fiberendoscopes and the simple medication permit its wide and sure use. The direct visualization of mucosal surface allows to see even small alteration always not found by roentgenological examination and to pick up aimed bioptic specimens. The therapeutic contribution revealed itself affective in our experience, permitting polipectomy and consequently rectal bleeding removal. It was possible at last by this technique to make the follow-up of patients with ulcerative colitis avoiding them repeated irradiations. We can thus conclude that gastrointestinal endoscopy has an important diagnostic and therapeutic value also in pediatric patients for the study of gastrointestinal diseases.

[Giardiasis in children. Ultrastructural study of the parasite]. / Giardiasi in etá pediatrica. Studio ultrastrutturale del parassita.

Giardia lamblia is the first protozoan to be identified and recognized as an important pathogen in human disease. We studied 8 pediatric patients with giardiasis in order to examine the clinical spectrum, the structural changes of the small intestinal mucosa and mainly the protozoan's ultrastructural features. The most common clinical manifestations were diarrhea, abdominal pain, anorexia, vomiting, failure to thrive. Infection was confirmed by excreted cysts in the stools in one patient, by the presence of trophozoites in duodenal aspirate and on jejunal mucosa. Giardiasis was not associated with hypogammaglobulinemia in our patients and no or only slight mucosal abnormalities were present in jejunal biopsies, except one which showed a flat mucosa. Specimens for transmissions and scanning electron microscopy were taken. We could establish the protozoan's features, its normal distribution, its relationship to intestinal mucosa and structural indications of the normal reaction of intestine with the use of ultrastructural techniques. The trophozoites colonized the proximal intestine, adhered to microvilli of columnar cells near the bases of villi, wedged or lodged in mucus. The sticky mucus producing an effective diffusion barrier to nutrients could explain malabsorption phenomena. Numerous intraluminal lymphocytes were seen, suggesting an immune response. These observations indicate that in giardiasis the clinical spectrum and structural changes of the small intestinal mucosa vary widely, suggesting a different reaction of immune system and/or a different degree of infection.