Severe imported malaria involving hyperparasitemia (≥ 10%) in non-immune children: Assessment of French practices.

BACKGROUND: Plasmodium falciparum hyperparasitemia (over or equal to 10%), isolated or associated with other severity criteria, should be managed in a pediatric intensive care unit according to the French pediatric guidelines. The main objective of our study was to describe the management and course of these special cases. POPULATION AND METHODS: We conducted a retrospective study in eight French hospital facilities from January 2007 to December 2014. We reviewed the management of non-immune children aged 0-15 years, assessing the following: clinical and paraclinical data, type of care unit, treatment initiated, initial and long-term course. Data were analyzed for the whole population and for two groups according to the place of first-line management: group A (in pediatric intensive care unit), and group B (other places). RESULTS: A total of 61 children were included, 14 (23%) of whom were initially admitted to the intensive care unit (group A), all with neurological or hemodynamic disorders. Only 23 children (38%) overall received intravenous antimalarial treatment and the other patients received exclusively oral treatment. No deaths were reported. Median parasitemia was comparable in the two groups. In group B (n = 47/61, 77%), isolated hyperparasitemia, jaundice, and renal failure were predominant. The children who underwent initial intravenous treatment (n = 5/47, 11%) all progressed favorably, as did 92% of the children who received oral treatment (n = 42/47, 89%). CONCLUSION: A majority of children with Plasmodium falciparum hyperparasitemia were managed outside the pediatric intensive care unit via the oral route, against the French pediatric guidelines except when neurologic or hemodynamic disorders were present. Initial clinical evaluation and hospital supervision are essential for the best management of these patients.

Lack of potential carcinogenicity for sucralose - Systematic evaluation and integration of mechanistic data into the totality of the evidence.

Sucralose is widely used as a sugar substitute. Many studies and authoritative reviews have concluded that sucralose is non-carcinogenic, based primarily on animal cancer bioassays and genotoxicity data. To add to the body of knowledge on the potential carcinogenicity of sucralose, a systematic assessment of mechanistic data was conducted. This entailed using a framework developed for the quantitative integration of data related to the proposed key characteristics of carcinogens (KCCs). Data from peer-reviewed literature and the ToxCast/Tox21 database were evaluated using an algorithm that weights data for quality and relevance. The resulting integration demonstrated an overall lack of activity for sucralose across the KCCs, with no "strong" activity observed for any KCC. Almost all data collected demonstrated inactivity, including those conducted in human models. The overall lack of activity in mechanistic data is consistent with findings from animal cancer bioassays. The few instances of activity across the KCC were generally accompanied by limitations in study design in the context of either quality and/or dose and model relevance, highlighted upon integration of the totality of the evidence. The findings from this comprehensive and integrative evaluation of mechanistic data support prior conclusions that sucralose is unlikely to be carcinogenic in humans.