BackgroundIn many malaria-endemic, sub-Saharan African countries, existing pharmacovigilance systems are not sufficiently operational to document reliably the safety profile of anti-malarial drugs. This study describes the implantation of a community-based pharmacovigilance system in Côte d’Ivoire and its use to document the safety of ASAQ Winthrop® (artesunate–amodiaquine).MethodsThis prospective, longitudinal, descriptive, non-comparative, non-interventional study on the use of artesunate–amodiaquine in real-life conditions of use was conducted in seven Community Health Centres of the Agboville district in Côte d’Ivoire. Twenty trained Health Centre employees and 70 trained community health workers were involved in data collection in the field. All patients with suspected uncomplicated falciparum malaria, seeking treatment at one of the participating Health Centres, and treated with artesunate–amodiaquine could be enrolled. Two visits were planned, one for inclusion at the Health Centre and a second at home, performed by a community health worker 3–10 days after the inclusion visit. Administration of artesunate–amodiaquine was unsupervised. Adverse events (AEs) were documented at the home visit or during any unexpected visit to the Health Centre or to the hospital and coded and adjudicated by a local pharmacovigilance committee. Symptoms suggestive of hepatic failure, severe neutropaenia, extrapyramidal disorders and retinopathy were considered a priori as AEs of special interest.ResultsSome 15,228 malaria episodes in 12,198 patients were evaluated; 2545 AEs were documented during 1978 malaria episodes (13.0%). The most frequently observed events were asthenia (682 cases), vomiting (482 cases) and somnolence (174 cases). Most reported AEs were of mild or moderate intensity and resolved without corrective treatment. One-hundred and five (105) AEs reported during 100 episodes (0.7%) were considered as serious. Three serious cases of transient extrapyramidal disorders, identified as AEs of special interest were reported in three patients.ConclusionThe fixed dose artesunate–amodiaquine combination ASAQ Winthrop® for the unsupervised treatment of uncomplicated falciparum malaria under real-life conditions of care in Côte d’Ivoire is well tolerated. The study emphasizes the interest of involving properly trained community health workers to collect pharmacovigilance data in the field in order to document rare AEs.Electronic supplementary materialThe online version of this article (doi:10.1186/s12936-016-1655-1) contains supplementary material, which is available to authorized users.

The objective of this study was to monitor the effectiveness of artesunate-amodiaquine fixed-dose combination tablets (ASAQ Winthrop®) in the treatment of uncomplicated Plasmodium falciparum malaria in Côte d'Ivoire. Two enrolment periods (November 2009 to May 2010 and March to October 2013) were compared using an identical design. Subjects with proven monospecific P. falciparum infection according to the WHO diagnostic criteria were eligible. 290 patients during each period received a dose of ASAQ Winthrop tablets appropriate for their age. The primary outcome measure was PCR-corrected adequate clinical and parasitological response at Day 28 in the per protocol population (255 in Period 1 and 240 in Period 2). This was achieved by 95.7% of patients during Period 1 and 96.3% during Period 2. Over 95% of patients were afebrile at Day 3 and complete parasite clearance was achieved at Day 3 in >99% of patients. Nineteen adverse events in nineteen patients were considered as possibly related to treatment, principally vomiting, abnormal liver function tests, and pruritus. There was no evidence for loss of effectiveness over the three-year period in spite of strong drug pressure. This trial was registered in the US Clinical Trials Registry (clinical.trials.gov) under the identifier number NCT01023399.

Introduction: Children are likely to present with atypical and non-specific clinical manifestations of COVID-19, unlike adults. The aim of this observation is to identify the difficulties related to the diagnosis and the curative and preventive management of SARS-CoV-2 infection in children. Observation: This is a 15-month-old infant admitted for febrile seizures. The interrogation revealed signs evolving 48 hours before his admission marked by post-prandial vomiting, wet cough, hypotonia, food refusal, incessant crying, fever, and seizures. His antecedents can be summed up as an uneventful pre-and per-natal period, good eating habits, good psychomotor and staturo-ponderal development, and outdated vaccination. The physical and paraclinical examination made it possible to retain the diagnosis of severe pneumonia. The initial management consisted of oxygenation, hydroelectrolyte intake, antibiotic therapy, and neurosedation. The evolution 3 days later was marked by a worsening of the clinical features, and the hypothesis of infection with SARS-CoV-2 was raised. The nasopharyngeal swab for COVID-19 RT-PCR performed was positive. The infant was isolated in the intensive care unit, where he received oxygen therapy with a mask, enteral nutrition, antibiotic therapy, corticosteroid therapy, and adequate nursing. The evolution was favorable 48 hours later. In addition, his asymptomatic mother and 14-year-old brother were placed in isolation after a positive RT-PCR COVID-19 test. Her father who was very often away from home for professional reasons was negative for COVID-19