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Papers by Andrea Falaschi

Research paper thumbnail of Improving Antibiotics Use in Pediatric Hospitals in Argentina: Feasibility Study

medRxiv (Cold Spring Harbor Laboratory), Feb 13, 2024

Research paper thumbnail of Clinical leadership and coping strategies in times of COVID-19: observational study with health managers in Mendoza

BMC Health Services Research

Background The outbreak of the COVID-19 pandemic required an immediate response to the healthcare... more Background The outbreak of the COVID-19 pandemic required an immediate response to the healthcare challenges it posed. This study was conducted to identify actions that helped healthcare professionals to overcome the initial impact in Mendoza (Argentina). Methods A cross-sectional study was carried out in a non-random sample of managers and staff of the public health system of Mendoza (Argentina) (n = 134). An ad-hoc and voluntary survey was carried out with 5 multi-response questions that combined questions referring to the management of the pandemic at the organizational level with others referring to coping at the individual level. The survey questions were formulated based on the results of six focus groups that were conducted previously. Descriptive frequency analysis was performed. Results 60 people agreed to participate and 45 answered the full questionnaire. At both the organizational and individual level, there was consensus with at least 50% of votes. The most outstanding ...

Research paper thumbnail of Enfermedad invasiva por Haemophilus influenzae b: disminución de la incidencia en la era postvaccinal

Research paper thumbnail of Chest X-ray classification and CAP end point definitions

<p>Chest X-ray classification and CAP end point definitions.</p

Research paper thumbnail of Vaccination schedule

<p>The following vaccines were used: PHiD-CV, Synflorix; diphtheria–tetanus–acellular pertu... more <p>The following vaccines were used: PHiD-CV, Synflorix; diphtheria–tetanus–acellular pertussis–hepatitis B–inactivated poliovirus–<i>Haemophilus influenzae</i> type b vaccine (DTPa-HBV-IPV/Hib), Infanrix hexa; DTPa-IPV/Hib, Infanrix-IPV/Hib; hepatitis B, Engerix-B; hepatitis A, Havrix (all by GlaxoSmithKline Vaccines). In addition to these blinded study vaccines, the following vaccines were administered or were recommended: measles–mumps–rubella vaccine at 12 mo of age, hepatitis B vaccination at birth, and hepatitis A vaccination at 12 and 18–21 mo of age, with the second dose given at least 28 days after the study vaccine booster dose. In Argentina, <i>Neisseria meningitidis</i> group C conjugate vaccine (NeisVac-C, Baxter International) was offered at 12 mo of age; in Colombia and Panama, varicella vaccine (Varilrix, GlaxoSmithKline Vaccines) was offered at 12 mo of age; in Colombia, two doses of oral rotavirus vaccine (Rotarix, GlaxoSmithKline Vaccines) were offered within the first 6 mo of life.</p

Research paper thumbnail of Study objectives

<p>AOM, acute otitis media; B-CAP, likely bacterial community-acquired pneumonia; C-AOM, cl... more <p>AOM, acute otitis media; B-CAP, likely bacterial community-acquired pneumonia; C-AOM, clinically confirmed acute otitis media; CAP, community-acquired pneumonia; CRP, C-reactive protein; IPD, invasive pneumococcal disease; PHiD-CV, pneumococcal nontypable <i>Haemophilus influenzae</i> protein D conjugate vaccine; SAE, serious adverse event; VT, vaccine serotype.</p

Research paper thumbnail of Comparison of Epidemiologic and Clinical COVID-19 Profiles in Children in Argentina, During Circulation of Original and Variant (Alpha, Gamma and Lambda) Strains

Pediatric Infectious Disease Journal

Research paper thumbnail of 2128. Lack of Congenital Transmission in Infants Born of Female Patients with Chagas Disease who Became Pregnant During a Nifurtimox Study (CHICO and CHICO SECURE Study)

Open Forum Infectious Diseases, Dec 1, 2022

Research paper thumbnail of Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial

PLoS medicine, 2014

The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection... more The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed. This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at boos...

Research paper thumbnail of Serious adverse events reported from study start and administration of the first vaccine dose up to study end in at least 1.0% of children (intent-to-treat cohort: all children)

Research paper thumbnail of Trial profile for children included in the end-of-study analysis of acute otitis media

<p>Elimination criteria shown for one reason only, although more than one reason for elimin... more <p>Elimination criteria shown for one reason only, although more than one reason for elimination could apply per child. <sup>a</sup>Forbidden underlying medical conditions included, but were not limited to, major congenital defects, serious chronic illness, or confirmed or suspected immunosuppressive or immunodeficient conditions.</p

Research paper thumbnail of Trial profile for children included in the analysis of the primary study end point

<p>Elimination criteria shown for one reason only, although more than one reason for elimin... more <p>Elimination criteria shown for one reason only, although more than one reason for elimination could apply per child. <sup>a</sup>Forbidden underlying medical conditions included, but were not limited to, major congenital defects, serious chronic illness, or confirmed or suspected immunosuppressive or immunodeficient conditions.</p

Research paper thumbnail of Efficacy of PHiD-CV against first community-acquired pneumonia and invasive pneumococcal disease episodes

<p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox reg... more <p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox regression model based on time to first episode when at least one event was observed in each group and conditional on number of cases when no case in at least one group (i.e., VE equal to zero or −infinite (VE, 1 − [<i>x</i>/0]).</p>a<p>Number of first episodes during the respective follow-up period divided by <i>n</i>, multiplied by 100.</p>b<p>Significant <i>p</i>-value (<i>p</i> = 0.002); one-sided <i>p</i>-value from Cox regression model to test null hypothesis VE ≤ 0% with one-sided alpha of 1.75%.</p>c<p><i>S. pneumoniae</i> was isolated from all culture-confirmed invasive disease cases.</p>d<p>Pneumococcal serotype 6A, 9N, or 19A.</p><p>NC, not calculable.</p

Research paper thumbnail of Characteristics of the trial participants included in the analysis of the primary study end point (CAP efficacy cohort; interim analysis), CAP and IPD end-of-study analysis (CAP/IPD efficacy cohort), and AOM end-of-study analysis (AOM efficacy cohort)

a<p>59% of participants were recruited in Argentina (race predominantly white or with Europ... more a<p>59% of participants were recruited in Argentina (race predominantly white or with European heritage), and the remaining were recruited in Colombia and Panama (participants predominantly mixed race).</p>b<p>Follow-up time calculated as sum of follow-up periods of each child, expressed in years, censored at the first occurrence of a respective end point event.</p>c<p>Recruited in Panama only.</p><p>SD, standard deviation.</p

Research paper thumbnail of Efficacy of PHiD-CV against first acute otitis media episodes (end-of-study analysis)

<p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox reg... more <p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox regression model based on time to first episode.</p>a<p>Number of first episodes during the respective follow-up period divided by <i>n</i>, multiplied by 100.</p>b<p>Pneumococcal serotype 6A, 18B, 19A, or 23A.</p

Research paper thumbnail of Comparison of Epidemiological and Clinical COVID-19 Profiles in Children in Argentina, During Circulation of Original and Variant (Alfa, Gamma and Lambda) Strains

Research paper thumbnail of Surveillance of SARS-CoV-2 variants in Argentina: detection of Alpha, Gamma, Lambda, Epsilon and Zeta in locally transmitted and imported cases

Research paper thumbnail of A multicenter study of confirmed COVID-19 cases: preliminary data on 2690 pediatric patients in Argentina during the first year of the pandemic

Archivos argentinos de pediatria, 2022

INTRODUCTION The current evidence indicates that the severity of the coronavirus disease 2019 (CO... more INTRODUCTION The current evidence indicates that the severity of the coronavirus disease 2019 (COVID-19) is lower in the pediatric population but local data are still limited. Objective: To characterize the clinical and epidemiological aspects of COVID-19 infection in patients younger than 18 years in Argentina. POPULATION AND METHODS Cross-sectional, observational, and analytical study of confirmed COVID-19 patients aged 0-18 years seen between March 2020 and March 2021 at 19 referral children's hospitals of Argentina. A multivariate analysis was done to identify predictors of severe cases. RESULTS A total of 2690 COVID-19 cases were included: 77.7% lived in the Metropolitan Area of Buenos Aires; 50.1% were males; patients' median age was 5.6 years. Of them, 90% were seen during epidemiological weeks 20-47 of 2020; 60.4% had a history of contact with COVID-19 patients; and 96.6% in their family setting. Also, 51.4% had respiratory symptoms; 61.6%, general symptoms; 18.8%, g...

Research paper thumbnail of Infection Prevention and Control Program in a Public Pediatric Hospital in Argentina: Opportunities for Improvement

American Journal of Infection Control, 2012

Research paper thumbnail of Aspectos clínicos y epidemiológicos de la invaginación intestinal en niños menores de 2 años, de la provincia de Mendoza, Argentina

Archivos Argentinos De Pediatria, 2006

Research paper thumbnail of Improving Antibiotics Use in Pediatric Hospitals in Argentina: Feasibility Study

medRxiv (Cold Spring Harbor Laboratory), Feb 13, 2024

Research paper thumbnail of Clinical leadership and coping strategies in times of COVID-19: observational study with health managers in Mendoza

BMC Health Services Research

Background The outbreak of the COVID-19 pandemic required an immediate response to the healthcare... more Background The outbreak of the COVID-19 pandemic required an immediate response to the healthcare challenges it posed. This study was conducted to identify actions that helped healthcare professionals to overcome the initial impact in Mendoza (Argentina). Methods A cross-sectional study was carried out in a non-random sample of managers and staff of the public health system of Mendoza (Argentina) (n = 134). An ad-hoc and voluntary survey was carried out with 5 multi-response questions that combined questions referring to the management of the pandemic at the organizational level with others referring to coping at the individual level. The survey questions were formulated based on the results of six focus groups that were conducted previously. Descriptive frequency analysis was performed. Results 60 people agreed to participate and 45 answered the full questionnaire. At both the organizational and individual level, there was consensus with at least 50% of votes. The most outstanding ...

Research paper thumbnail of Enfermedad invasiva por Haemophilus influenzae b: disminución de la incidencia en la era postvaccinal

Research paper thumbnail of Chest X-ray classification and CAP end point definitions

<p>Chest X-ray classification and CAP end point definitions.</p

Research paper thumbnail of Vaccination schedule

<p>The following vaccines were used: PHiD-CV, Synflorix; diphtheria–tetanus–acellular pertu... more <p>The following vaccines were used: PHiD-CV, Synflorix; diphtheria–tetanus–acellular pertussis–hepatitis B–inactivated poliovirus–<i>Haemophilus influenzae</i> type b vaccine (DTPa-HBV-IPV/Hib), Infanrix hexa; DTPa-IPV/Hib, Infanrix-IPV/Hib; hepatitis B, Engerix-B; hepatitis A, Havrix (all by GlaxoSmithKline Vaccines). In addition to these blinded study vaccines, the following vaccines were administered or were recommended: measles–mumps–rubella vaccine at 12 mo of age, hepatitis B vaccination at birth, and hepatitis A vaccination at 12 and 18–21 mo of age, with the second dose given at least 28 days after the study vaccine booster dose. In Argentina, <i>Neisseria meningitidis</i> group C conjugate vaccine (NeisVac-C, Baxter International) was offered at 12 mo of age; in Colombia and Panama, varicella vaccine (Varilrix, GlaxoSmithKline Vaccines) was offered at 12 mo of age; in Colombia, two doses of oral rotavirus vaccine (Rotarix, GlaxoSmithKline Vaccines) were offered within the first 6 mo of life.</p

Research paper thumbnail of Study objectives

<p>AOM, acute otitis media; B-CAP, likely bacterial community-acquired pneumonia; C-AOM, cl... more <p>AOM, acute otitis media; B-CAP, likely bacterial community-acquired pneumonia; C-AOM, clinically confirmed acute otitis media; CAP, community-acquired pneumonia; CRP, C-reactive protein; IPD, invasive pneumococcal disease; PHiD-CV, pneumococcal nontypable <i>Haemophilus influenzae</i> protein D conjugate vaccine; SAE, serious adverse event; VT, vaccine serotype.</p

Research paper thumbnail of Comparison of Epidemiologic and Clinical COVID-19 Profiles in Children in Argentina, During Circulation of Original and Variant (Alpha, Gamma and Lambda) Strains

Pediatric Infectious Disease Journal

Research paper thumbnail of 2128. Lack of Congenital Transmission in Infants Born of Female Patients with Chagas Disease who Became Pregnant During a Nifurtimox Study (CHICO and CHICO SECURE Study)

Open Forum Infectious Diseases, Dec 1, 2022

Research paper thumbnail of Efficacy of pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) in young Latin American children: A double-blind randomized controlled trial

PLoS medicine, 2014

The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection... more The relationship between pneumococcal conjugate vaccine-induced antibody responses and protection against community-acquired pneumonia (CAP) and acute otitis media (AOM) is unclear. This study assessed the impact of the ten-valent pneumococcal nontypable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV) on these end points. The primary objective was to demonstrate vaccine efficacy (VE) in a per-protocol analysis against likely bacterial CAP (B-CAP: radiologically confirmed CAP with alveolar consolidation/pleural effusion on chest X-ray, or non-alveolar infiltrates and C-reactive protein ≥ 40 µg/ml); other protocol-specified outcomes were also assessed. This phase III double-blind randomized controlled study was conducted between 28 June 2007 and 28 July 2011 in Argentine, Panamanian, and Colombian populations with good access to health care. Approximately 24,000 infants received PHiD-CV or hepatitis control vaccine (hepatitis B for primary vaccination, hepatitis A at boos...

Research paper thumbnail of Serious adverse events reported from study start and administration of the first vaccine dose up to study end in at least 1.0% of children (intent-to-treat cohort: all children)

Research paper thumbnail of Trial profile for children included in the end-of-study analysis of acute otitis media

<p>Elimination criteria shown for one reason only, although more than one reason for elimin... more <p>Elimination criteria shown for one reason only, although more than one reason for elimination could apply per child. <sup>a</sup>Forbidden underlying medical conditions included, but were not limited to, major congenital defects, serious chronic illness, or confirmed or suspected immunosuppressive or immunodeficient conditions.</p

Research paper thumbnail of Trial profile for children included in the analysis of the primary study end point

<p>Elimination criteria shown for one reason only, although more than one reason for elimin... more <p>Elimination criteria shown for one reason only, although more than one reason for elimination could apply per child. <sup>a</sup>Forbidden underlying medical conditions included, but were not limited to, major congenital defects, serious chronic illness, or confirmed or suspected immunosuppressive or immunodeficient conditions.</p

Research paper thumbnail of Efficacy of PHiD-CV against first community-acquired pneumonia and invasive pneumococcal disease episodes

<p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox reg... more <p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox regression model based on time to first episode when at least one event was observed in each group and conditional on number of cases when no case in at least one group (i.e., VE equal to zero or −infinite (VE, 1 − [<i>x</i>/0]).</p>a<p>Number of first episodes during the respective follow-up period divided by <i>n</i>, multiplied by 100.</p>b<p>Significant <i>p</i>-value (<i>p</i> = 0.002); one-sided <i>p</i>-value from Cox regression model to test null hypothesis VE ≤ 0% with one-sided alpha of 1.75%.</p>c<p><i>S. pneumoniae</i> was isolated from all culture-confirmed invasive disease cases.</p>d<p>Pneumococcal serotype 6A, 9N, or 19A.</p><p>NC, not calculable.</p

Research paper thumbnail of Characteristics of the trial participants included in the analysis of the primary study end point (CAP efficacy cohort; interim analysis), CAP and IPD end-of-study analysis (CAP/IPD efficacy cohort), and AOM end-of-study analysis (AOM efficacy cohort)

a<p>59% of participants were recruited in Argentina (race predominantly white or with Europ... more a<p>59% of participants were recruited in Argentina (race predominantly white or with European heritage), and the remaining were recruited in Colombia and Panama (participants predominantly mixed race).</p>b<p>Follow-up time calculated as sum of follow-up periods of each child, expressed in years, censored at the first occurrence of a respective end point event.</p>c<p>Recruited in Panama only.</p><p>SD, standard deviation.</p

Research paper thumbnail of Efficacy of PHiD-CV against first acute otitis media episodes (end-of-study analysis)

<p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox reg... more <p>VE estimated as one minus the hazard ratio and obtained, with its 95% CI, from a Cox regression model based on time to first episode.</p>a<p>Number of first episodes during the respective follow-up period divided by <i>n</i>, multiplied by 100.</p>b<p>Pneumococcal serotype 6A, 18B, 19A, or 23A.</p

Research paper thumbnail of Comparison of Epidemiological and Clinical COVID-19 Profiles in Children in Argentina, During Circulation of Original and Variant (Alfa, Gamma and Lambda) Strains

Research paper thumbnail of Surveillance of SARS-CoV-2 variants in Argentina: detection of Alpha, Gamma, Lambda, Epsilon and Zeta in locally transmitted and imported cases

Research paper thumbnail of A multicenter study of confirmed COVID-19 cases: preliminary data on 2690 pediatric patients in Argentina during the first year of the pandemic

Archivos argentinos de pediatria, 2022

INTRODUCTION The current evidence indicates that the severity of the coronavirus disease 2019 (CO... more INTRODUCTION The current evidence indicates that the severity of the coronavirus disease 2019 (COVID-19) is lower in the pediatric population but local data are still limited. Objective: To characterize the clinical and epidemiological aspects of COVID-19 infection in patients younger than 18 years in Argentina. POPULATION AND METHODS Cross-sectional, observational, and analytical study of confirmed COVID-19 patients aged 0-18 years seen between March 2020 and March 2021 at 19 referral children's hospitals of Argentina. A multivariate analysis was done to identify predictors of severe cases. RESULTS A total of 2690 COVID-19 cases were included: 77.7% lived in the Metropolitan Area of Buenos Aires; 50.1% were males; patients' median age was 5.6 years. Of them, 90% were seen during epidemiological weeks 20-47 of 2020; 60.4% had a history of contact with COVID-19 patients; and 96.6% in their family setting. Also, 51.4% had respiratory symptoms; 61.6%, general symptoms; 18.8%, g...

Research paper thumbnail of Infection Prevention and Control Program in a Public Pediatric Hospital in Argentina: Opportunities for Improvement

American Journal of Infection Control, 2012

Research paper thumbnail of Aspectos clínicos y epidemiológicos de la invaginación intestinal en niños menores de 2 años, de la provincia de Mendoza, Argentina

Archivos Argentinos De Pediatria, 2006