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Biomedical subjects

Xavier Sáez-Llorens

Publications and source records attributed to Xavier Sáez-Llorens.

14 recordsLinked to original sources
PubMed2006

Safety and efficacy of an attenuated vaccine against severe rotavirus gastroenteritis.

BACKGROUND: The safety and efficacy of an attenuated G1P[8] human rotavirus (HRV) vaccine were tested in a randomized, double-blind, phase 3 trial. METHODS: We studied 63,225 healthy infants from 11 Latin American countries and Finland who received two oral doses of either the HRV vaccine (31,673 infants) or placebo (31,552 infants) at approximately two months and four months of age. Severe gastroenteritis episodes were identified by active surveillance. The severity of disease was graded with the use of the 20-point Vesikari scale. Vaccine efficacy was evaluated in a subgroup of 20,169 infants (10,159 vaccinees and 10,010 placebo recipients). RESULTS: The efficacy of the vaccine against severe rotavirus gastroenteritis and against rotavirus-associated hospitalization was 85 percent (P<0.001 for the comparison with placebo) and reached 100 percent against more severe rotavirus gastroenteritis. Hospitalization for diarrhea of any cause was reduced by 42 percent (95 percent confidence interval, 29 to 53 percent; P<0.001). During the 31-day window after each dose, six vaccine recipients and seven placebo recipients had definite intussusception (difference in risk, -0.32 per 10,000 infants; 95 percent confidence interval, -2.91 to 2.18; P=0.78). CONCLUSIONS: Two oral doses of the live attenuated G1P[8] HRV vaccine were highly efficacious in protecting infants against severe rotavirus gastroenteritis, significantly reduced the rate of severe gastroenteritis from any cause, and were not associated with an increased risk of intussusception. (ClinicalTrials.gov numbers, NCT00139347 and NCT00263666.)

Administration, Oral↗
PubMed2005

Randomized, investigator-blinded, multicenter study of gatifloxacin versus amoxicillin/clavulanate treatment of recurrent and nonresponsive otitis media in children.

BACKGROUND: Decreased susceptibility of pathogens to currently used agents for recurrent otitis media has provided the impetus for identifying new antimicrobial options. OBJECTIVE: To compare gatifloxacin with amoxicillin/clavulanate in children with recurrent or nonresponsive acute otitis media (AOM). METHODS: Included in this multicenter randomized trial were 413 patients, ranging in age from 6 months to 7 years, who had recurrent AOM (at least 3 episodes in the previous 6 months or 4 episodes in the previous 12 months) and/or had failed antibiotic therapy for AOM within 14 days of enrollment. Diagnosis required evidence of acute inflammation and otoscopic findings of middle ear effusion; baseline tympanocentesis was optional and encouraged. Children were randomly assigned (2:1) to 10 days of oral therapy with gatifloxacin suspension (10 mg/kg of body weight once daily) or amoxicillin/clavulanate suspension (45/6.4 mg/kg/d in 2 divided doses). RESULTS: : Clinical cure was obtained in 90.2% (222 of 246) of patients in the gatifloxacin group and 84.3% (102 of 121) of those in the amoxicillin/clavulanate group (95% confidence interval, -1.9-12.9) 3-10 days after treatment ended. Gatifloxacin was associated with higher clinical cure rates than was amoxicillin/clavulanate in children younger than 2 years of age (92.0% versus 80.0%, respectively). Cure rates by pretreatment pathogen in the gatifloxacin and amoxicillin/clavulanate groups were 92.1% (35 of 38) versus 88.9% (16 of 18) for Streptococcus pneumoniae infections and 88.2% (30 of 34) versus 92.3% (12 of 13) for Haemophilus influenzae infections, respectively. Sustained clinical cures 3-4 weeks after treatment ended were obtained in 74.4% (183 of 246) of patients treated with gatifloxacin and 72.7% (88 of 121) of those treated with amoxicillin/clavulanate. Adverse events considered drug-related occurred with similar frequency in the 2 groups. Six patients (2.2%) in the gatifloxacin group and 2 patients (1.5%) in the amoxicillin/clavulanate group developed transient symptoms of mild or moderate arthralgia. CONCLUSIONS: In this comparative evaluation of fluoroquinolone therapy in children with AOM, gatifloxacin was similar in clinical efficacy to amoxicillin/clavulanate 45/6.4 mg/kg/d for treatment of recurrent/nonresponsive infections.

Amoxicillin-Potassium Clavulanate Combination↗
PubMed2004

Intussusception and rotavirus vaccines: what is the background risk?

The first rotavirus vaccine was associated with a small, albeit statistically significant, risk of intussusception in immunized infants. Before results of new vaccine studies are available, we need to define the real background risk of intussusception in participating countries. A 5-year retrospective study conducted in Panama found an average rate of 1 case per 3300 infants younger than 1 year of age, with substantial yearly variations ranging from 1:2500 to 1:5000.

Age Distribution↗
PubMed2004

Cerebrospinal fluid and plasma concentrations of proinflammatory mediators in human immunodeficiency virus-infected children.

BACKGROUND: The pathogenesis of HIV encephalopathy is poorly understood especially in children. Studies suggest that HIV replication and the release of proinflammatory mediators in the central nervous system contribute to the pathogenesis of HIV dementia in adults. METHODS: Cerebrospinal fluid (CSF) and plasma samples from 23 HIV-infected children were longitudinally analyzed at Weeks 0, 8, 16 and 48 for HIV RNA and concentrations of the following proinflammatory mediators: monocyte chemotactic protein-1 (MCP-1), tumor necrosis factor-alpha, regulated upon activation, normal T cell expressed and secreted (RANTES), macrophage-inflammatory protein (MIP)-1-alpha, MIP-1-beta and matrix metalloproteinase-9 (MMP-9). RESULTS: All 23 children had detectable concentrations of MCP-1 in the CSF at all time points evaluated. However, of the remaining of proinflammatory mediators measured in CSF at baseline, only a few children had detectable concentrations: tumor necrosis factor-alpha, n = 1; RANTES, n = 5; MMP-9, n = 9; MIP-1-alpha and MIP-1-beta, n = 0. A reduction from baseline to Week 48 was observed in CSF concentrations of MCP-1 and, among children with detectable values, MMP-9, which paralleled declines in CSF HIV RNA. CONCLUSION: These results suggest that MCP-1 and MMP-9 may be involved in the pathogenesis of central nervous system disease in HIV-infected children.

AIDS Dementia Complex↗
PubMed2004

Safety and pharmacokinetics of palivizumab therapy in children hospitalized with respiratory syncytial virus infection.

BACKGROUND: Respiratory syncytial virus (RSV) infection represents a major cause of pediatric respiratory hospitalizations. Limited treatment options exist. Palivizumab is a humanized monoclonal IgG1 antibody to the fusion protein of RSV that is highly active against RSV A and B strains. METHODS: A phase I/II, multicenter, randomized, double-blind, placebo-controlled, escalating dose clinical trial to describe the safety, tolerance, pharmacokinetics and clinical outcome of a single intravenous dose of palivizumab in previously healthy children hospitalized with acute RSV infection. RESULTS: Fifty-nine children < or =2 years of age received study drug. Sixteen children received 5 mg/kg of palivizumab (n = 8) or placebo (n = 8); 43 received 15 mg/kg of palivizumab (n = 22) or placebo (n = 21). Adverse events judged to be related to study drug were seen in one 5-mg/kg palivizumab patient and one 15-mg/kg palivizumab patient. These events were transient or consistent with progression of RSV disease. No discontinuations of study drug infusion because of adverse events occurred. Mean serum concentrations of palivizumab in the 5- and 15-mg/kg groups, respectively, were 61.2 and 303.4 microg/mL at 60 min and 11.2 and 38.4 microg/mL after 30 days. There were no significant differences in clinical outcomes between placebo and palivizumab groups for either dose. CONCLUSIONS: Intravenous palivizumab was safe and well-tolerated in children hospitalized with RSV disease. A single 15-mg/kg dose achieved serum palivizumab concentrations above the 25- to 30-microg/mL concentration associated with 2-log reduction of pulmonary RSV titer in the cotton rat model.

Antibodies, Monoclonal↗
PubMed2003

Bacterial meningitis in children.

This review comprises aspects of the epidemiology, microbiology, pathophysiology, clinical manifestations, diagnosis, management, prognosis, and prevention of bacterial meningitis, with emphasis on the paediatric population. The beginning of this millennium has witnessed the virtual disappearance of Haemophilus invasive disease in some countries, emergence of pneumococcal strains that are resistant to multiple antibiotics, isolation of pneumococci with tolerance to vancomycin, outbreaks and clusters of meningococcal meningitis in several geographical areas, and intense research in development of effective conjugate pneumococcal and meningococcal vaccines. Bacterial meningitis has become an uncommon disease in the developed world. Unfortunately, because of limited economic resources and poor living conditions, many developing countries are still affected by the devastating consequences of this life-threatening systemic infection. Basic and clinical research is needed to discover new antimicrobial and anti-inflammatory agents to improve outcome from disease. Novel strategies are needed to distribute and implement effective vaccines worldwide to prevent bacterial meningitis.

Child↗
PubMed2003

Brain abscess in children.

Brain abscess is a relatively uncommon but life-threatening infection in children. It can originate from contiguous site infections (eg, chronic otitis media, mastoiditis, sinusitis, meningitis), from distant pathologic states (eg, cyanotic congenital heart disease, chronic lung infections), after head trauma or neurosurgical procedures, or from cryptogenic sources. Predominant etiologic microorganisms vary depending on these predisposing factors. Computed tomography and magnetic resonance imaging are essential tools that enable the physician to make an accurate diagnosis of intracranial purulent collections. Proper selection of antimicrobial agents with good penetration of the central nervous system and with adequate coverage of both anaerobic and aerobic bacteria is critical for the medical management of brain abscess. Delay in surgical drainage can be associated with high morbidity and case-fatality rates. In the early phase of cerebritis, however, infection can respond to antibiotic therapy alone. Advances in diagnostic and therapeutic modalities during the last decade have improved the prognosis of this serious disease.

Anti-Bacterial Agents↗
PubMed2003

Forty-eight-week evaluation of lopinavir/ritonavir, a new protease inhibitor, in human immunodeficiency virus-infected children.

BACKGROUND: Lopinavir/ritonavir has demonstrated antiviral activity in the HIV-infected adult. SUBJECTS: The objective of this study was to investigate a liquid coformulation of lopinavir/ritonavir, in combination with reverse transcriptase inhibitors, in HIV-infected children. METHODS: One hundred antiretroviral (ARV)-naive and ARV-experienced, nonnucleoside reverse transcriptase inhibitor-naive children between 6 months and 12 years of age participated in this Phase I/II, open label, multicenter trial. Subjects initially received either 230/57.5 mg/m(2) or 300/75 mg/m(2) lopinavir/ritonavir twice daily; ARV-naive subjects also received stavudine and lamivudine, whereas ARV-experienced subjects also received nevirapine and one or two nucleoside reverse transcriptase inhibitors. Lopinavir/ritonavir pharmacokinetics, safety and efficacy were evaluated. RESULTS: All subjects were escalated to the 300/75 mg/m(2) twice daily dose based on results from an interim pharmacokinetic and safety evaluation. The pharmacokinetics of lopinavir did not appear to be dependent on age when dosing was based on body surface area but were decreased on coadministration with nevirapine. Overall 79% of subjects had HIV RNA levels <400 copies/ml at Week 48 (intent-to-treat: missing = failure). Mean increases in absolute and relative (percent) CD4 counts from baseline to Week 48 were observed in both ARV-naive subjects (404 cells/mm(3); 10.3%) and ARV-experienced subjects (284 cells/mm(3); 5.9%). Only one subject prematurely discontinued the study because of a study drug-related adverse event. CONCLUSIONS: The liquid coformulation of lopinavir/ritonavir demonstrated durable antiviral activity and was safe and well-tolerated after 48 weeks of treatment in HIV-infected children.

Administration, Oral↗
PubMed2003

Open label, multicenter study of gatifloxacin treatment of recurrent otitis media and acute otitis media treatment failure.

BACKGROUND: Recurrent otitis media and treatment failures of acute infections are refractory to therapy. Newer fluoroquinolones have excellent activity against respiratory pathogens, but their use in children has been limited because of concerns about adverse effects. METHODS: This was an open label, multicenter trial in which patients with recurrent otitis media or acute otitis media (AOM) treatment failure were treated with 10 mg/kg gatifloxacin oral suspension once daily for 10 days. Before treatment a tympanocentesis or a swab of middle ear fluid was obtained. Nasopharyngeal swabs were obtained at baseline and at the end of therapy. Efficacy was evaluated 3 to 10 days after cessation of treatment and at 3 to 4 weeks. Safety monitoring included special attention to any sign or symptom suggestive of joint or bone abnormality. RESULTS: The study enrolled 254 patients 6 months to 7 years of age, with one-half (52%) of the patients having recurrent otitis media, 17% having AOM treatment failure and 28% having both. Cure was achieved posttreatment in 88% of 198 clinically evaluable patients, with similar outcomes for patients younger or older than 2 years of age. Of the 45 evaluable patients with Streptococcus pneumoniae, 38 (84%) were cured, including 25 of 28 with penicillin-nonsusceptible strains. Also cured were 89% of those with Haemophilus influenzae and those with Moraxella catarrhalis. No selection of resistance to gatifloxacin was detected among nasopharyngeal pathogens. Eighty-three percent of the children had sustained cure at the 4 weeks follow-up visit. Adverse events were primarily mild gastrointestinal, with no occurrences of arthropathy. CONCLUSION: Gatifloxacin is safe and effective for treatment of recurrent otitis media and AOM treatment failure in children.

Acute Disease↗
PubMed2002

Effect of combination antiretroviral therapy on cerebrospinal fluid HIV RNA, HIV resistance, and clinical manifestations of encephalopathy.

OBJECTIVES: This study evaluated the effect of treatment with abacavir/lamivudine/zidovudine versus lamivudine/zidovudine on cerebrospinal fluid (CSF) human immunodeficiency virus (HIV) RNA and clinical manifestations of HIV encephalopathy in children. STUDY DESIGN: HIV-infected children 7 months to 10 years of age (n = 23) were studied. CSF and plasma were obtained at baseline and weeks 8, 16, and 48. Genotype analysis of HIV was attempted at baseline and week 48. Neurologic evaluations were performed at baseline and weeks 16, 32, and 48. RESULTS: At baseline, 83% of children had >2.00 log(10) copies/mL HIV RNA in CSF, but only 10% had HIV RNA measurable at week 48. Among children in whom paired genotyping of HIV was possible, 8 of 11 had identical patterns in both CSF and plasma at baseline, whereas at week 48, only 1 of 9 children had similar patterns. Neurologic abnormalities were observed in 83% of children at baseline but only 35% of children at week 48 (P =.004), suggesting a benefit of treatment. CONCLUSIONS: Antiretroviral therapy was associated with a decline in CSF HIV RNA and an improvement in neurologic status. The development of genotypic mutations was different in CSF and plasma, suggesting discordant viral evolution. These results suggest that antiretroviral treatment in children should include agents with activity in the CNS.

AIDS Dementia Complex↗
PubMed2002

Quinolone treatment for pediatric bacterial meningitis: a comparative study of trovafloxacin and ceftriaxone with or without vancomycin.

BACKGROUND: Trovafloxacin is a new fluoroquinolone that exhibits good penetration into the central nervous system and excellent antimicrobial activity against common meningeal pathogens, including beta-lactam-resistant pneumococci. PURPOSE AND DESIGN: A multicenter, randomized clinical trial was conducted in children with bacterial meningitis to compare the safety and efficacy of trovafloxacin with that of ceftriaxone with or without vancomycin therapy. RESULTS: A total of 311 patients, ages 3 months to 12 years, were enrolled, of whom 203 were fully evaluable, 108 treated with trovafloxacin and 95 with the conventional regimen. Both groups were comparable with regard to baseline characteristics: age; cerebrospinal fluid findings; use of dexamethasone; history of seizures; and etiologic agents. No significant differences between trovafloxacin and the comparator, respectively, were detected in any of the following outcome measures: clinical success at 5 to 7 weeks after treatment (79% vs. 81%); deaths (2% vs. 3%); seizures after enrollment (22% vs. 21%); and severe sequelae (14% vs. 14%). Only 4 of 284 children developed joint abnormalities up to 6 months after treatment, 1 (0.9%) child received trovafloxacin and 3 (3.1%) received the comparator regimen. None of the evaluable patients experienced significant abnormalities of liver function during treatment. One nonevaluable patient who received trovafloxacin for 5 days and ceftriaxone for 11 days was readmitted to the hospital with hepatitis of unknown etiology 1 day after discharge. The episode resolved with liver function tests returning to normal within 2 months. CONCLUSIONS: We conclude that trovafloxacin is an effective antibiotic for treatment of pediatric bacterial meningitis. These favorable results support further evaluation of fluoroquinolone therapy for children with meningitis or other serious bacterial infections.

Anti-Infective Agents↗
PubMed2002

Starry, starry night.

Explore the source record for details and available documents.

AIDS-Related Opportunistic Infections↗
PubMed2002

[Complications and costs associated with chickenpox in immunocompetent children].

OBJECTIVES: Chickenpox is a common infection of childhood in countries that have not included the corresponding vaccination in their immunization schedules. Chickenpox is usually benign in immunocompetent children, and treatment is not needed. The objectives of this study were to investigate the frequency and characteristics of chickenpox complications that require hospital treatment in immunocompetent children and the clinical progression in children of mothers with perinatal chickenpox. In addition, the hospital costs associated with chickenpox in the studied children were calculated. METHODS: This was a retrospective study using the clinical records of children with chickenpox hospitalized at the Children's Hospital of Panama, from January 1991 through December 2000. We analyzed the types of complications, the clinical progression, and the hospital costs of the chickenpox patients. RESULTS: Of 5 203 children seen in outpatient consultations, 568 of them (11%) were hospitalized. We included 513 children in our study: 381 (74%) with chickenpox acquired in the community, 92 (18%) the children of mothers with chickenpox, and 40 (8%) with nosocomial chickenpox. The most frequent complications were cutaneous and subcutaneous infections (45%), respiratory infections (25%), and neurological changes (7%). The respiratory and cutaneous complications occurred sooner and among younger patients than did the neurological changes. Overall, 13 of the children (2.5%) died. The case fatality rate was 8% for chickenpox with respiratory and neurological complications and 0% for chickenpox with cutaneous complications. Of the 92 children with a mother with chickenpox, 60 of them (65%) did not develop the disease, and none of the 92 died. In contrast, 2 of the 32 neonates (6%) with perinatal chickenpox died. The mean length of hospitalization was 8.9 days (standard deviation, +/- 17.4 days). Parenteral pharmacotherapy was used with the great majority of the children, particularly antibiotics (54%), acyclovir (17%), and intravenous immunoglobulin (14%). The mean per-patient cost of hospitalization was US$ 1 209. CONCLUSIONS: Our results show that chickenpox is associated with a sizable number of expensive complications and a not-insignificant case fatality rate in immunocompetent children. Routine vaccination against chickenpox could reduce the impact of this disease on the health of children in Panama

Acyclovir↗