•Community representatives should be involved from the early phases of any tuberculosis trials.•Their participation and role should be active, avoiding tokenism.•Representatives should be trained to ...fit the role to be able to contribute.
Community representatives are key to ensuring that tuberculosis (TB) research is relevant, culturally sensitive, and appropriate. For all trials (new drugs or treatment regimens, diagnostics, or vaccines) this can result in improvement of recruitment, retention, and adherence to the trial schedule. The early engagement of the community will, later in time, support the process of implementation of new policies designed for successful products. We aim at developing a structured protocol for the early engagement of TB community representatives developed in the context of the EU-Patient-cEntric clinicAl tRial pLatforms (EU-PEARL) project.
The EU-PEARL Innovative Medicine Initiative 2 (IMI2) project TB work package has developed a community engagement (CE) framework to ensure fair and efficient participation of the community in the design and implementation of TB clinical platform trials.
We showed that early engagement of the EU-PEARL community advisory board highly contributes to the process of development of a community-acceptable Master Protocol Trial and Intervention-Specific Appendixes. We identified capacity building and training as major gaps in advancing CE in the TB field.
Developing strategies to address these needs can contribute to preventing tokenism and increase the acceptability and appropriateness of TB research.
The screening and treatment of latent tuberculosis infection (LTBI) in countries with a low incidence of TB is a key strategy for the elimination of tuberculosis (TB). However, treatment can result ...in adverse events (AEs) and have poor adherence. This study aimed to describe treatment outcomes and AEs for LTBI patients at two departments in Vall d'Hebron University Hospital in Barcelona, Spain. A retrospective study was conducted on all persons treated for LTBI between January 2018 and December 2020. Variables collected included demographics, the reason for LTBI screening and treatment initiation, AEs related to treatment, and treatment outcome. Out of 261 persons who initiated LTBI treatment, 145 (55.6%) were men, with a median age of 42.1 years. The indications for LTBI screening were household contact of a TB case in 96 (36.8%) persons, immunosuppressive treatment in 84 (32.2%), and recently arrived migrants from a country with high TB incidence in 81 (31.0%). Sixty-three (24.1%) persons presented at least one AE during treatment, and seven (2.7%) required definitive discontinuation of treatment. In the multivariate analysis, AE development was more frequent in those who started LTBI treatment due to immunosuppression. Overall, 226 (86.6%) completed treatment successfully. We concluded that LTBI screening and treatment groups had different risks for adverse events and treatment outcomes. Persons receiving immunosuppressive treatment were at higher risk of developing AEs, and recently arrived immigrants from countries with a high incidence of TB had greater LTFU. A person-centered adherence and AE management plan is recommended.
Previous clinical trials for drug-susceptible tuberculosis (DS-TB) have shown that first-line treatment with doses of rifampicin up to 40 mg/kg are safe and increase the early treatment response for ...young adults with pulmonary tuberculosis. This may lead to a shorter treatment duration for those persons with TB and a good baseline prognosis, or increased treatment success for vulnerable subgroups (age > 60, diabetes, malnutrition, HIV, hepatitis B or hepatitis C coinfection, TB meningitis, stable chronic liver diseases). Here, we describe the design of a phase 2b/c clinical study under the hypothesis that rifampicin at 35 mg/kg is as safe for these vulnerable groups as for the participants included in previous clinical trials. RIAlta is an interventional, open-label, multicenter, prospective clinical study with matched historical controls comparing the standard DS-TB treatment (isoniazid, pyrazinamide, and ethambutol) with rifampicin at 35 mg/kg (HR35ZE group) vs. rifampicin at 10 mg/kg (historical HR10ZE group). The primary outcome is the incidence of grade ≥ 3 Adverse Events or Severe Adverse Events. A total of 134 participants will be prospectively included, and compared with historical matched controls with at least a 1:1 proportion. This will provide a power of 80% to detect non-inferiority with a margin of 8%. This study will provide important information for subgroups of patients that are more vulnerable to TB bad outcomes and/or treatment toxicity. Despite limitations such as non-randomized design and the use of historical controls, the results of this trial may inform the design of future more inclusive clinical trials, and improve the management of tuberculosis in subgroups of patients for whom scientific evidence is still scarce. Trial registration: EudraCT 2020-003146-36, NCT04768231.
Objectives In a previous study performed by our group, Strongyloides stercoralis infection in patients with Chagas disease was associated with higher proportion of Trypanosoma cruziDNA detection in ...peripheral blood. The aim of the study was to confirm this association in a larger cohort of patients. Methods Cross-sectional study of all patients with Chagas disease diagnosed from 2005 to 2015 during blood donation at the Catalan Blood Bank. Demographic data and T. cruziRT-PCR were collected. S. stercoralis infection diagnosis was based on a serological test. Results Two hundred and two blood donors were included. T. cruziRT-PCR was positive in 72 (35.6%) patients, and S. stercoralis serology was positive in 22 (10.9%) patients. Patients with positive S. stercoralis serology had higher proportion of positive T. cruziRT-PCR than those with negative serology (54.5% vs. 33.3%, P = 0.050), and the difference increased when taking a serological index cut-off of 2.5, which increases the specificity of the test to detect a confirmed strongyloidiasis (60% vs. 33%, P = 0.017). Conclusions Patients with Chagas disease with positive S. stercoralis serology had higher proportion of positive T. cruziRT-PCR in peripheral blood than those with negative serology, which reflects the potential immunomodulatory effects of S. stercoralis in T. cruzi co-infected patients. Objectifs Dans une étude précédente réalisée par notre groupe, l'infection par S. stercoralis chez les patients atteints de la maladie de Chagas était associée à une proportion plus élevée de détection d'ADN de Trypanosoma cruzi dans le sang périphérique. Le but de cette étude était de confirmer cette association dans une plus grande cohorte de patients. Méthodes Etude transversale de tous les patients atteints de la maladie de Chagas, diagnostiqués entre 2005 et 2015 au cours du don de sang à la banque de sang catalane. Les données démographiques et de la RT-PCR de T. cruzi ont été recueillies. Le diagnostic de l'infection par S. stercoralis était basé sur un test sérologique. Résultats 202 donneurs de sang ont été inclus. La RT-PCR pour T. cruzi était positive chez 72 (35,6%) patients et la sérologie de S. stercoralis était positive chez 22 (10,9%) patients. Les patients avec une sérologie positive pour S. stercoralis avaient une proportion plus élevée de RT-PCR positives pour T. cruzi que ceux avec une sérologie négative (54,5% contre 33,3%, p = 0,050) et la différence augmentait lorsqu'un seuil de 2,5 de l'indice sérologique était considéré, ce qui augmente la spécificité du test pour détecter une strongyloïdose confirmée (60% contre 33%, p = 0,017). Conclusions Les patients atteints de la maladie de Chagas avec une sérologie positive pour S. stercoralis avaient une plus forte proportion de RT-PCR positives pour T. cruzi dans le sang périphérique que ceux avec sérologie négative, ce qui reflète les effets immunomodulateurs potentiels de S. stercoralis chez les patients coinfectés avec T. cruzi.
The Spanish Society of Infectious Diseases and Clinical Microbiology (SEIMC), the Spanish Society of Tropical Medicine and International Health (SEMTSI), the Spanish Association of Surgeons (AEC), ...the Spanish Society of Pneumology and Thoracic Surgery (SEPAR), the Spanish Society of Thoracic Surgery (SECT), the Spanish Society of Vascular and Interventional Radiology (SERVEI), and the Spanish Society of Paediatric Infectious Diseases (SEIP) considered it pertinent to issue a consensus statement on the management of cystic echinococcosis (CE) to guide healthcare professionals in the care of patients with CE.
Specialists from several fields (clinicians, surgeons, radiologists, microbiologists, and parasitologists) identified the most clinically relevant questions and developed this Consensus Statement, evaluating the available evidence-based data to propose a series of recommendations on the management of this disease. This Consensus Statement is accompanied by the corresponding references on which these recommendations are based.
Prior to publication, the manuscript was open for comments and suggestions from the members of the SEIMC and the scientific committees and boards of the various societies involved.
La Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica (SEIMC), la Sociedad Española de Medicina Tropical y Salud Internacional (SEMTSI), la Asociación Española de Cirujanos (AEC), la Sociedad Española de Neumología y Cirugía Torácica (SEPAR), la Sociedad Española de Cirugía Torácica (SECT), la Sociedad Española de Radiología Vascular e Intervencionista (SERVEI) y la Sociedad Española de Infectología Pediátrica (SEIP) han considerado pertinente la elaboración de una declaración de consenso sobre el tratamiento de la equinococosis quística (EQ) que sirva de ayuda al personal sanitario en la atención de pacientes con EQ.
Varios tipos de profesionales (médicos, cirujanos, radiólogos, microbiólogos y parasitólogos) han seleccionado las preguntas más clínicamente relevantes y han desarrollado esta Declaración de consenso, en la que evalúan los datos basados en la evidencia disponibles para proponer una serie de recomendaciones sobre el tratamiento de esta enfermedad. Esta Declaración de consenso se acompaña de la bibliografía correspondiente que fundamenta estas recomendaciones.
Antes de su publicación, el manuscrito estuvo abierto a comentarios y sugerencias de los miembros de la SEIMC y de los comités científicos y juntas directivas de las diferentes sociedades implicadas.
On February 1st 2016 the WHO declared the Zika Virus (ZIKV) infection a worldwide public health emergency because of its rapid expansion and severe complications, such as Guillain-Barré Syndrome or ...microcephaly in newborn. The huge amount of people traveling to endemic areas and the presence of
in Barcelona increase the risk of autochtonous transmission. The objective of this study was to describe the first ZIKV cases diagnosed in our city and to analyze the surveillance, prevention, and control measures implemented to avoid autochthonous transmission.
An observational cross-sectional population-based study in Barcelona, Spain was performed.An analysis of the socio-demographic, epidemiological, clinical characteristics, and mosquito control activities of the ZIKV cases detected between January 1st and December 2016 was carried out using a specific ZIKV epidemiological survey of the Barcelona Public Health Agency.
A total of 118 notifications of possible ZIKV infections were received, and 44 corresponded to confirmed cases in Barcelona residents.Amongst these, the median age was 35 years and 57% were women. All cases were imported, 48% were Spanish-born and 52% foreign-born. Dominican Republic was the most visited country amongst foreign-born patients and Nicaragua amongst Spanish-born. The most frequent symptoms were exanthema, fever, and arthralgia. Among the 24 diagnosed women, 6 (25%) were pregnant. There was one case of microcephaly outside Barcelona city. Entomological inspections were done at the homes of 19 cases (43.2% of the total) and in 34 (77.3%) public spaces. Vector activity was found in one case of the 44 confirmed cases, and 134 surveillance and vector control were carried out associated to imported ZIKV cases. In all cases prevention measures were recommended to avoid mosquito bites on infected cases.
Epidemiological and entomological surveillance are essential for the prevention of autochthonous transmission of arbovirosis that may have a great impact on Public Health.The good coordination between epidemiologists, entomologists, microbiologists, and clinicians is a priority in a touristic city with an intense relationship with endemic countries to minimize the risk of local transmission by competent vectors.
Metodos En marzo de 2015, se inicio un programa de rastreo de contactos basado en centros sanitarios en el Hospital Nossa Senhora da Paz y se siguio hasta 2022. En ese tiempo, la dotacion de personal ...y las pruebas variaron, lo que clasificamos en cuatro periodos: refuerzo del personal medico, de 2015 a 2017, con un medico enviado en comision de servicios desde el Hospital Universitario Vall d'Hebron (Espana); personal de rutina, de 2017 a 2021, sin apoyo medico externo; tratamiento directamente observado (TDO) en la poblacion, de 2018 a 2019, con apoyo de trabajadores comunitarios; y rastreo de contactos mejorado, de 2021 a 2022, con financiacion que permitio realizar radiografias de torax y pruebas moleculares y de aspirado gastrico gratuitas. Se evaluaron las diferencias en los contactos atendidos al mes y las pruebas y el tratamiento ofrecidos en los cuatro periodos. Resultados En total, el programa evaluo 1978 contactos de 969 casos de referencia. La participacion en el programa fue baja, aunque aumento de manera significativa durante el periodo de TDO en la poblacion. Solo el 16,6% (329/1978) de los contactos se sometieron a una radiografia de torax. La confirmacion microbiologica aumento al 72,2% (26/36) tras incluir las pruebas moleculares y el 10,1% (200/1978) de los contactos recibieron tratamiento para la tuberculosis. De 457 contactos menores de 5 anos, 36 (7,9%) recibieron tratamiento preventivo contra la tuberculosis. Se perdio el seguimiento de la mitad de los contactos antes de que se tomara una decision final sobre el tratamiento.
Gastrointestinal symptoms are a common cause of consultation about children traveling to or coming from developing countries. The aim of this study was to identify the risk factors associated with ...gastrointestinal syndrome in children who travel.
A prospective observational analytical and multicenter study was performed within +Redivi, a Spanish Tropical Medicine network on imported infections, from January 2009 to December 2013. All participants aged 16 years and younger were included in the analysis. Ethical approval was obtained from all the participating centers.
A total of 606 children ≤16 years of age were registered in the +Redivi database during the study period. Median age was 8.7 years (interquartile range, 4.4-12.4 years), 65.8% (399/606) were immigrants, 90% were >2 years old and 54% were male. Median travel duration, excluding immigrants, was 50 days (interquartile range, 30-150 days). Children with gastrointestinal symptoms represented 13.5% (82/606) of total consultations. A significant association was found in bivariate analysis between gastrointestinal disorder and age <2 years (P < 0.01) and travel duration (P = 0.046). Immigrants had less gastrointestinal disorders than tourists (P < 0.05). The most prevalent infection was protozoan in 23.4% (142/606), and Giardia intestinalis was the most common pathogen in 10.1% (61/606) of total children. Independent risk factors for gastrointestinal symptoms were tourist and traveler child visiting friends and relatives (P = 0.03), travel duration <90 days (P = 0.008) and bacterial cause (P < 0.001).
Traveling children who developed a gastrointestinal syndrome represented 13.5% of the total pediatric consultations in +Redivi. Independent risk factors were tourist or traveler visiting friends and relatives, travel duration <90 days and bacterial infection. G. intestinalis was the most common infectious agent causing a gastrointestinal disorder in the traveler children.
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