Institute Atencion Pediatrica

San José, Costa Rica

Institute Atencion Pediatrica

San José, Costa Rica
Time filter
Source Type

Abdelnour A.,Institute Atencion Pediatrica | Silas P.E.,Wee Care Pediatrics | Lamas M.R.V.,Guanchipelin | Chiu N.-C.,Mackay Memorial Hospital | And 8 more authors.
Vaccine | Year: 2014

Background: The highest risk for invasive meningococcal disease (IMD) is in infants aged <1 year. Quadrivalent meningococcal conjugate vaccination has the potential to prevent IMD caused by serogroups A, C, W and Y. This phase 3b, multinational, open-label, randomized, parallel-group, multicenter study evaluated the safety of a 4-dose series of MenACWY-CRM, a quadrivalent meningococcal conjugate vaccine, concomitantly administered with routine vaccinations to healthy infants. Methods: Two-month-old infants were randomized 3:1 to receive MenACWY-CRM with routine vaccines or routine vaccines alone at ages 2, 4, 6 and 12 months. Adverse events (AEs) that were medically attended and serious adverse events (SAEs) were collected from all subjects from enrollment through 18 months of age. In a subset, detailed safety data (local and systemic solicited reactions and all AEs) were collected for 7 days post vaccination. The primary objective was a non-inferiority comparison of the percentages of subjects with ≥1 severe systemic reaction during Days 1-7 after any vaccination of MenACWY-CRM plus routine vaccinations versus routine vaccinations alone (criterion: upper limit of 95% confidence interval [CI] of group difference <6%). Results: A total of 7744 subjects were randomized with 1898 in the detailed safety arm. The percentage of subjects with severe systemic reactions was 16% after MenACWY-CRM plus routine vaccines and 13% after routine vaccines alone (group difference 3.0% (95% CI -0.8, 6.4%). Although the non-inferiority criterion was not met, post hoc analysis controlling for significant center and group-by-center differences revealed that MenACWY-CRM plus routine vaccinations was non-inferior to routine vaccinations alone (group difference -0.1% [95% CI -4.9%, 4.7%]). Rates of solicited AEs, medically attended AEs, and SAEs were similar across groups. Conclusion: In a large multinational safety study, a 4-dose series of MenACWY-CRM concomitantly administered with routine vaccines was clinically acceptable with a similar safety profile to routine vaccines given alone. © 2013 Elsevier Ltd.

PubMed | Pfizer, Institute Atencion Pediatrica and Hospital Nacional Of Ninos
Type: | Journal: Current therapeutic research, clinical and experimental | Year: 2014

The pharmacokinetic profile of azithromycin supports its use as single-dose therapy for uncomplicated acute otitis media (AOM) in children.This study was designed to (1) compare the safety of single-dose oral azithromycin, 3 daily doses of oral azithromycin, and a single dose of intramuscular ceftriaxone for the treatment of uncomplicated AOM in children, and (2) provide preliminary efficacy data to support initiation of a larger, comparative trial of single-dose azithromycin for the treatment of uncomplicated acute otitis media in children.In this single-center pilot study, children with uncomplicated AOM were randomly assigned to receive single-dose oral azithromycin (30 mg/kg), 3-day oral azithromycin (10 mg/kg once daily), or single-dose intramuscular ceftriaxone (50 mg/kg). Tympanocentesis was performed before administration of the first dose, and clinical response was assessed on days 14-15 and 28-30.Between September 1995 and May 1997, 198 children (mean age, 2.5 years) were enrolled. All of the patients were evaluable for the safety and clinical intent-to-treat (ITT) analyses, and 98 were evaluable for the microbiologic ITT analysis. On day 14-15, rates of clinical success (cure or improvement) for the 3 treatment groups were: 62/64 (97%) for single-dose azithromycin, 60/63 (95%) for 3-day azithromycin, and 61/62 (98%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 61/65 (94%), 61/66 (92%), and 62/64 (97%). For the 98 microbiologically evaluable patients, clinical success rates at day 14-15 were 28/30 (93%) for single-dose azithromycin, 31/35 (89%) for 3-day azithromycin, and 33/33 (100%) for single-dose ceftriaxone. On day 28-30, the corresponding clinical success rates were 27/30 (90%), 30/35 (86%), and 32/33 (97%). Treatment-related adverse event rates for single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone were 10.6%, 9.1%, and 9.1%, respectively.In this pilot study comparing single-dose azithromycin, 3-day azithromycin, and single-dose ceftriaxone for the treatment of uncomplicated AOM in children, no differences were detected among the 3 regimens.

Arguedas A.,Institute Atencion Pediatrica | Soley C.,Institute Atencion Pediatrica | Abdelnour A.,Institute Atencion Pediatrica | Sales V.,Novartis | And 3 more authors.
Human Vaccines | Year: 2011

Background: The recent global A/H1N1v pandemic led to major efforts to develop effective vaccines against the novel virus, while global demand and limited production capacity focused attention on dose sparing and schedules. Results: All three vaccines elicited immune responses in 9-17 year-olds meeting CBER criteria three weeks after one dose; responses were not enhanced by second dose. In 3-8 year-olds only the adjuvanted vaccine met the CBER criteria after one dose, but all three vaccines met the criteria criteria after second dose. All vaccines were well tolerated; no related Serious Adverse Events (SAE) and few severe solicited reactions were reported. MF59-adjuvanted vaccine was associated with more reports of injection site pain and tenderness and overall systemic solicited reactions, most notably in older subjects, all of which decreased after the second dose. Methods: An open-label phase III study of immunogenicity and safety of novel A/H1N1v vaccines included 392 Costa Rican children in two pediatric cohorts (3-8 and 9-17 years). They received two doses, of either an MF59®-adjuvanted formulation containing 7.5 μg antigen or non-adjuvanted formulations containing 15 or 30 μg antigen, three weeks apart. Immunogenicity was assessed as hemagglutination inhibition (HI) titers using the CBER licensure criteria. Conclusion: One dose of non-adjuvanted A/H1N1v vaccine is adequate in 9-17 year-olds, but younger children require either one dose of MF59-adjuvanted vaccine or two doses of non-adjuvanted vaccine to achieve protective titers. Enhanced immunogenicity with MF59 is associated with a small increase in reactogenicity, but no safety issues. © 2011 Landes Bioscience.

Lozoff B.,University of Michigan | Smith J.B.,Oakland University | Kaciroti N.,University of Michigan | Clark K.M.,University of Michigan | And 2 more authors.
Journal of Pediatrics | Year: 2013

Objective To evaluate adulthood function following chronic iron deficiency in infancy. Study design At 25 years, we compared 33 subjects with chronic iron deficiency in infancy to 89 who were iron-sufficient before and/or after iron therapy. Outcomes included education, employment, marital status, and physical and mental health. Results Adjusting for sex and socioeconomic status, a higher proportion of the group with chronic iron deficiency did not complete secondary school (58.1% vs 19.8% in iron-sufficient group; Wald value = 8.74; P =.003), were not pursuing further education/training (76.1% vs 31.5%; Wald value = 3.01; P =.08; suggestive trend), and were single (83.9% vs 23.7%, Wald value = 4.49; P =.03). They reported poorer emotional health and more negative emotions and feelings of dissociation/detachment. Results were similar in secondary analyses comparing the chronic iron-deficient group with subjects in the iron-sufficient group who had been iron-deficient before treatment in infancy. Path analysis showed direct paths for chronic iron deficiency in infancy and being single and more detachment/dissociation at 25 years. There were indirect paths for chronic iron deficiency and not completing secondary school via poorer cognitive functioning in early adolescence and more negative emotions via behavior problems in adolescence, indicating a cascade of adverse outcomes. Conclusion The observational nature of this study limits our ability to draw causal inference, even when controlling for background factors. Nonetheless, our results indicate substantial loss of human potential. There may be broader societal implications, considering that many adults worldwide had chronic iron deficiency in infancy. Iron deficiency can be prevented or treated before it becomes chronic or severe. © 2013 Mosby Inc. All rights reserved.

Vergison A.,Free University of Colombia | Dagan R.,Ben - Gurion University of the Negev | Arguedas A.,Institute Atencion Pediatrica | Bonhoeffer J.,University of Basel | And 12 more authors.
The Lancet Infectious Diseases | Year: 2010

An international group of multidisciplinary experts on middle-ear and paediatric infections met to explore where consensus exists on the management of acute otitis media. After informal discussions among several specialists of paediatric infectious disease, the group was expanded to include a larger spectrum of professionals with complementary expertise in middle-ear disease. Acute otitis media is a very common bacterial infection in children worldwide, leading to excessive antibiotic consumption in children in most countries and to a substantial burden of deafness and suppurative complications in developing countries. The group attempted to move beyond the existing controversies surrounding guidelines on acute otitis media, and to propose to clinicians and public health officials their views on the actions needed to be taken to reduce the disease burden caused by acute otitis media and the microbial antibiotic resistance from the resulting use of antibiotics. Definition of acute otitis media and diagnostic accuracy are crucial steps to identify children who will potentially benefit from treatment with antibiotics and to eliminate unnecessary prescribing. Although the group agreed that antibiotics are distributed indiscriminately, even to children who do not seem to have the disease, no consensus could be reached on whether antibiotics should be given to all appropriately diagnosed children, reflecting the wide range of practices and lack of convincing evidence from observational studies. The major unanimous concern was an urgent need to reduce unnecessary prescribing of antibiotics to prevent further increases in antibiotic resistance. Prevention of acute otitis media with existing and future viral and bacterial vaccines seems the most promising approach to affect disease burden and consequences, both in developed and developing countries. © 2010 Elsevier Ltd. All rights reserved.

Arguedas A.,Institute Atencion Pediatrica | Soley C.,Institute Atencion Pediatrica | Loaiza C.,Institute Atencion Pediatrica | Rincon G.,Institute Atencion Pediatrica | And 10 more authors.
Vaccine | Year: 2010

This Phase III study evaluates an investigational quadrivalent meningococcal CRM 197 conjugate vaccine, MenACWY-CRM (Novartis Vaccines), when administered concomitantly or sequentially with two other recommended adolescent vaccines; combined tetanus, reduced diphtheria and acellular pertussis (Tdap), and human papillomavirus (HPV) vaccine. In this single-centre study, 1620 subjects 11-18 years of age, were randomized to three groups (1:1:1) to receive MenACWY-CRM concomitantly or sequentially with Tdap and HPV. Meningococcal serogroup-specific serum bactericidal assay using human complement (hSBA), and antibodies to Tdap antigens and HPV virus-like particles were determined before and 1 month after study vaccinations. Proportions of subjects with hSBA titres ≥1:8 for all four meningococcal serogroups (A, C, W-135, Y) were non-inferior for both concomitant and sequential administration. Immune responses to Tdap and HPV antigens were comparable when these vaccines were given alone or concomitantly with MenACWY-CRM. All vaccines were well tolerated; concomitant or sequential administration did not increase reactogenicity. MenACWY-CRM was well tolerated and immunogenic in subjects 11-18 years of age, with comparable immune responses to the four serogroups when given alone or concomitantly with Tdap or HPV antigens. This is the first demonstration that these currently recommended adolescent vaccines could be administered concomitantly without causing increased reactogenicity. © 2010 Elsevier Ltd. All rights reserved.

Arguedas A.,Institute Atencion Pediatrica | Arguedas A.,University of Medical Sciences of Costa Rica | Soley C.,Institute Atencion Pediatrica | Kamicker B.J.,Pfizer | Jorgensen D.M.,Pfizer
International Journal of Infectious Diseases | Year: 2011

Objectives: A randomized, double-blind, double-dummy, multicenter international study was conducted to assess the clinical and bacteriologic response, safety, and compliance of a single 60-mg/kg dose of azithromycin extended-release (ER) versus a 10-day regimen of amoxicillin/clavulanate 90/6.4. mg/kg per day in children with acute otitis media at high risk of persistent or recurrent middle ear infection. Methods: Children aged 3 to 48 months were enrolled and stratified into two age groups (≤24 months and >24 months). Pretreatment tympanocentesis was performed at all sites and was repeated during treatment at selected sites. Results: The primary endpoint, clinical response at the test-of-cure visit in the bacteriologic eligible population, was achieved in 80.5% of children in the azithromycin ER group and 84.5% of children in the amoxicillin/clavulanate group (difference - 3.9%; 95% confidence interval - 10.4, 2.6). Bacteriologic eradication was 82.6% in the azithromycin ER group and 92% in the amoxicillin/clavulanate group (p=0.050). Children who received amoxicillin/clavulanate had significantly higher rates of dermatitis and diarrhea, a greater burden of adverse events, and a lower rate of compliance to study drug compared to those who received azithromycin ER. Conclusions: A single 60-mg/kg dose of azithromycin ER provides near equivalent effectiveness to a 10-day regimen of amoxicillin/clavulanate 90/6.4. mg/kg per day in the treatment of children with acute otitis media. © 2011 International Society for Infectious Diseases.

Arguedas A.,Institute Atencion Pediatrica | Arguedas A.,University of Medical Sciences of Costa Rica | Abdelnour A.,Institute Atencion Pediatrica | Soley C.,Institute Atencion Pediatrica | And 7 more authors.
Vaccine | Year: 2012

Background: Streptococcus pneumoniae (SP) is the leading cause of vaccine-preventable death in children <5 years of age, globally. This surveillance determined incidence rates of invasive pneumococcal disease (IPD), clinical and chest radiograph-confirmed pneumonia (CXR. +. Pn); and SP serotype distribution and antimicrobial susceptibility in children in San José, Costa Rica. Methods: This was a 2-year prospective, population-based surveillance conducted in 2007-2009 in children aged 28 days to 36 months presenting to participating healthcare centers. Eligibility criteria for study inclusion were as follows: temperature ≥ 39.0 °C within 24. h and/or clinical suspicion of IPD or pneumonia. Results: 8801 subjects were enrolled. Median age: 14.5 months. A total of 25 children had invasive pneumococcal disease with S. pneumoniae isolated from nonduplicative cultures (22) or detected solely by PCR and a clinical picture consistent with IPD (3). Sources of positive cultures (some children had >1 positive culture) were: blood (20), pleural fluid (4), and cerebrospinal fluid (3). Of the 3 cases detected solely by PCR, 2 were from cerebrospinal fluid and 1 from pleural fluid. The overall IPD incidence rates for culture-positive only cases for children aged 28 days to <3 years was 33.7/100,000 per year for years 1 and 2 combined. Age stratification of culture-positive only subjects showed a peak during year 1 (106.8/100,000) in children 28 days to <6 months of age group, and in year 2 (45.5/100,000) in children 12 months to <24 months of age group. Most common serotypes were 14 (28.6%), followed by 3, 4, 6A, 19A, and 22F (9.5% each). Of 22 nonduplicative IPD isolates, 42.9% were penicillin- and trimethoprim/sulfamethoxazole nonsusceptible isolates. Consideration of PCR-positive cases increases the incidence of IPD for children aged 28 days to <3 years to 46.0/100,000. Overall incidence of clinical pneumonia and CXR. +. Pn was 1968/100,000 and 551/100,000, respectively. Conclusions: There is a considerable burden of IPD and pneumonia in children in San José. These epidemiologic data serve as a baseline to evaluate the effectiveness of the incorporation of new conjugate pneumococcal vaccines into the National Immunization Program in Costa Rican children. © 2012 Elsevier Ltd.

Guevara S.,Institute Atencion Pediatrica | Abdelnour A.,Institute Atencion Pediatrica | Soley C.,Institute Atencion Pediatrica | Soley C.,University of Medical Sciences of Costa Rica | And 4 more authors.
Vaccine | Year: 2012

Background: The heptavalent pneumococcal conjugate vaccine (PCV-7) was introduced in high risk children and into the private market in Costa Rica in 2004 (<5% annual birth cohort). The aim of this study was to compare the Streptococcus pneumoniae serotype (ST) distribution, antibiotic resistance patterns and potential coverage before and after partial introduction of PCV-7. Methods: A comparison between the S. pneumoniae isolates obtained and serotyped from the middle ear fluid (MEF) of Costa Rican children with otitis media between years 1999 and 2003 (before PCV-7 usage) and those isolates obtained from 2004 to 2008. Results: A total of 145 and 218 MEF S. pneumoniae were serotyped between years 1999 and 2003 and 2004 and 2008, respectively. Considering a 19F outbreak observed between years 1999 and 2003, the following statistically significant changes in serotype distribution were detected between1999 and 2003 and 2004 and 2008: ST 3: 4.8-12.8% (P= 0.01); ST 11A: 0-4.1% (P= 0.01); ST 14: 3.5-21.1% (P< 0.001) and ST 19F: 52.4-18.3% (P< 0.05). Comparison of the two study periods demonstrated that during 2004 and 2008 a statistically significant decrease in penicillin non-susceptible serotypes (36.2-20.4% [. P= 0.003]) and a statistically significant increase in trimethoprim-sulfametoxazole resistant serotypes (54.9-68.5%, respectively [. P= 0.03]) was observed. Potential pneumococcal vaccines coverage between 1999 and 2003 and between 2004 and 2008 were: for PCV-7: 77.2-60.5%, respectively (P= 0.001); for the 10-valent conjugated vaccine (PCV-10): 78.6-61.4%, respectively (P= 0.0008) and for the 13-valent conjugated vaccine (PCV-13): 84.8-79.3%, respectively (P= 0.2). Conclusions: Changes in the serotype distribution and antimicrobial susceptibility of MEF S. pneumoniae have been observed in Costa Rican children with OM. Because of the limited use of PCV-7 during the study period, these changes probably cannot be attributed to PCV-7 use. Between 2004 and 2008, PCV-13 offered the highest potential vaccine coverage. © 2012 Elsevier Ltd.

PubMed | Institute Atencion Pediatrica
Type: Clinical Trial | Journal: Chemotherapy | Year: 2015

Otitis media (OM) is one of the most common infections in children, Streptococcus pneumoniae and nontypable Haemophilus influenzae being the two most common pathogens isolated in the middle ear fluid (MEF) of children with OM. Cefditoren is a third-generation cephalosporin with broad-spectrum antibacterial activity, including activity against those pathogens commonly causing OM, with enhanced stability against common -lactamases. The main objective of this study was to evaluate the in vitro activity of cefditoren against pathogens collected from the MEF of Costa Rican children with OM between 2006 and 2011. A total of 715 samples were analyzed. Among the 89 S. pneumoniae strains that were penicillin-nonsusceptible, only 7% were cefditoren-resistant according to Spanish Regulatory Agency criteria; among the H. influenza and M. catarrhalis isolates obtained, 100 and 90% of the isolates, respectively, were cefditoren-susceptible. MIC50/90 against the 207 PCV-13 S. pneumoniae serotyped strains and the 79 serotypes not covered by PCV-13 for cefditoren were 0.03/1 and 0.03/0.12 mg/l, respectively. For both amoxicillin-susceptible and resistant H. influenzae strains, the MIC range against cefditoren was from 0.015 to 0.06 mg/l as well. In conclusion, the confirmation of the wide spectrum of activity of cefditoren and its intrinsic strength against resistant strains allows us to suggest that cefditoren might be included as one of the best choices among antibiotics that are widely used in empiric therapy for OM in pediatric patients.

Loading Institute Atencion Pediatrica collaborators
Loading Institute Atencion Pediatrica collaborators