Design of a monitoring system and its cost-effectiveness : optimization of biodiversity monitoring through close collaboration of users and data providers

At the European policy level there is demand for an international framework for surveillance and monitoring of biodiversity, indicating the growing need to quantify biodiversity composition and dynamics at large spatial and temporal scales to bridge the gap between international commitments and national and local actions, and to ensure that biodiversity monitoring and responses to biodiversity change are incorporated effectively into policy and practice at international, national and local levels. This report presents the results of the EBONE project on how such framework can be met effectively. It draws conclusions on sampling design, time management and sampling effectiveness

¿No es la misma de siempre esta mujer? Género, raza y poesía cubana de los ochenta en la obra poética de Soleida Ríos

Este artículo se propone determinar cuán revolucionarias fueron las construcciones poético discursivas de las categorías identitarias de raza y género, según las imágenes poéticas creadas por la escritora afrodescendiente cubana Soleida Ríos (Santiago de Cuba, 1950), en la década de los ochenta. Es decir, cómo la poeta se vio a sí misma como mujer negra, dentro de un contexto cuya retórica de igualdad se contradecía con su praxis diferenciadora. Me interesa la evolución de la mujer negra cubana a casi treinta años de iniciado el proyecto revolucionario del “hombre nuevo”. Analizo el diálogo del discurso poético con el discurso dominante (el político), para distinguir cuán considerable fue la participación de este último en la redefinición de las categorías género y raza, teniendo en cuenta que tales conceptos de identidad no son construcciones exclusivamente culturales, sino también políticas, camufladas estratégicamente detrás de lo cultural, tradicional e histórico

A randomised, double-blind clinical phase II trial of the efficacy, safety, tolerability and pharmacokinetics of a single dose combination treatment with artefenomel and piperaquine in adults and children with uncomplicated Plasmodium falciparum malaria

BACKGROUND: The clinical development of a single encounter treatment for uncomplicated malaria has the potential to significantly improve the effectiveness of antimalarials. Exploratory data suggested that the combination of artefenomel and piperaquine phosphate (PQP) has the potential to achieve satisfactory cure rates as a single dose therapy. The primary objective of the study was to determine whether a single dose of artefenomel (800 mg) plus PQP in ascending doses is an efficacious treatment for uncomplicated Plasmodium falciparum malaria in the 'target' population of children ≤ 5 years of age in Africa as well as Asian patients of all ages. METHODS: Patients in six African countries and in Vietnam were randomised to treatment with follow-up for 42-63 days. Efficacy, tolerability, safety and pharmacokinetics were assessed. Additional key objectives were to characterise the exposure-response relationship for polymerase chain reaction (PCR)-adjusted adequate clinical and parasitological response at day 28 post-dose (ACPR28) and to further investigate Kelch13 mutations. Patients in Africa (n = 355) and Vietnam (n = 82) were included, with 85% of the total population being children < 5 years of age. RESULTS: ACPR28 in the per protocol population (95% confidence interval) was 70.8% (61.13-79.19), 68.4% (59.13-76.66) and 78.6% (70.09-85.67) for doses of 800 mg artefenomel with 640 mg, 960 mg and 1440 mg of PQP respectively. ACPR28 was lower in Vietnamese than in African patients (66.2%; 54.55-76.62 and 74.5%; 68.81-79.68) respectively. Within the African population, efficacy was lowest in the youngest age group of ≥ 0.5 to ≤ 2 years, 52.7% (38.80-66.35). Initial parasite clearance was twice as long in Vietnam than in Africa. Within Vietnam, the frequency of the Kelch13 mutation was 70.1% and was clearly associated with parasite clearance half-life (PCt1/2). The most significant tolerability finding was vomiting (28.8%). CONCLUSIONS: In this first clinical trial evaluating a single encounter antimalarial therapy, none of the treatment arms reached the target efficacy of > 95% PCR-adjusted ACPR at day 28. Achieving very high efficacy following single dose treatment is challenging, since > 95% of the population must have sufficient concentrations to achieve cure across a range of parasite sensitivities and baseline parasitaemia levels. While challenging, the development of tools suitable for deployment as single encounter curative treatments for adults and children in Africa and to support elimination strategies remains a key development goal