Nutritional treatment of children 6-59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial

BACKGROUND: Admission criteria that treat children with low mid-upper-arm circumference (MUAC), and low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This study will address whether children with WAZ <-3 but MUAC ≥125 mm benefit from therapeutic feeding with ready-to-use therapeutic foods (RUTF) and whether a simplified protocol is non-inferior to the weight-based standard protocol. METHODS: This is a prospective individually randomized controlled 3-arm trial conducted in the Nara health district in Mali. Children aged 6-59 months presenting with MUAC ≥125 mm and WAZ <-3 will be randomized to (1) control group receiving no treatment, (2) simplified treatment receiving 1 sachet of RUTF daily until WAZ ≥-3 for 2 visits, (3) standard treatment receiving RUTF according to WHZ category: (a) WHZ <-3 receive 200 kcal/kg/day until WHZ ≥-2 for 2 visits, (b) WHZ ≥-3 but <-2 receive 1 sachet daily until WHZ ≥-2 for 2 visits or (c) WHZ ≥-2 receive no treatment. All children will be followed up first fortnightly for 12 weeks and then monthly until 6 months post-enrolment. The primary endpoint will be measured at 2 months with the primary outcome being WAZ as a continuous measure. Other outcomes include other anthropometric measurements and a secondary endpoint will be observed at 6 months. A total of 1397 children will be recruited including 209 in the control and 594 in both the simplified and standard arms. The sample size should enable us to conclude on the superiority of the simplified treatment compared to no treatment and on the non-inferiority of the simplified treatment versus standard treatment with a margin of non-inferiority of 0.2 WAZ. DISCUSSION: This trial aims to generate new evidence on the benefit of treating children with WAZ <-3 but MUAC ≥125 mm in order to guide the choice of admission criteria to malnutrition treatment and build evidence on the most efficient treatment protocol. TRIAL REGISTRATION: This trial was registered at ClinicalTrials.gov: NCT05248516 on February 21, 2022

Nutritional treatment of children 6–59 months with severely low weight-for-age z-score : a study protocol for a 3-arm randomized controlled trial

Background: Admission criteria that treat children with low mid-upper-arm circumference (MUAC), and low weight-for-height z-score (WHZ) are not aligned with the evidence on which children are at risk of mortality. An analysis of community-based cohort data from Senegal found that a combination of weight-for-age (WAZ) and MUAC criteria identified all children at risk of near-term death associated with severe anthropometric deficits. This study will address whether children with WAZ <−3 but MUAC ≥125 mm benefit from therapeutic feeding with ready-to-use therapeutic foods (RUTF) and whether a simplified protocol is non-inferior to the weight-based standard protocol. Methods: This is a prospective individually randomized controlled 3-arm trial conducted in the Nara health district in Mali. Children aged 6–59 months presenting with MUAC ≥125 mm and WAZ <−3 will be randomized to (1) control group receiving no treatment, (2) simplified treatment receiving 1 sachet of RUTF daily until WAZ ≥−3 for 2 visits, (3) standard treatment receiving RUTF according to WHZ category: (a) WHZ <−3 receive 200 kcal/kg/day until WHZ ≥−2 for 2 visits, (b) WHZ ≥−3 but <−2 receive 1 sachet daily until WHZ ≥−2 for 2 visits or (c) WHZ ≥−2 receive no treatment. All children will be followed up first fortnightly for 12 weeks and then monthly until 6 months post-enrolment. The primary endpoint will be measured at 2 months with the primary outcome being WAZ as a continuous measure. Other outcomes include other anthropometric measurements and a secondary endpoint will be observed at 6 months. A total of 1397 children will be recruited including 209 in the control and 594 in both the simplified and standard arms. The sample size should enable us to conclude on the superiority of the simplified treatment compared to no treatment and on the non-inferiority of the simplified treatment versus standard treatment with a margin of non-inferiority of 0.2 WAZ. Discussion: This trial aims to generate new evidence on the benefit of treating children with WAZ <−3 but MUAC ≥125 mm in order to guide the choice of admission criteria to malnutrition treatment and build evidence on the most efficient treatment protocol. Trial registration: This trial was registered at ClinicalTrials.gov: NCT05248516 on February 21, 2022.Peer reviewe

Challenges of scaling up and of knowledge transfer in an action research project in Burkina Faso to exempt the worst-off from health care user fees

<p>Abstract</p> <p>Background</p> <p>Systems to exempt the indigent from user fees have been put in place to prevent the worst-off from being excluded from health care services for lack of funds. Yet the implementation of these mechanisms is as rare as the operational research on this topic. This article analyzes an action research project aimed at finding an appropriate solution to make health care accessible to the indigent in a rural district of Burkina Faso.</p> <p>Research</p> <p>This action research project was initiated in 2007 to study the feasibility and effectiveness of a community-based, participative and financially sustainable process for exempting the indigent from user fees. A interdisciplinary team of researchers from Burkina Faso and Canada was mobilized to document this action research project.</p> <p>Results and knowledge sharing</p> <p>The action process was very well received. Indigent selection was effective and strengthened local solidarity, but coverage was reduced by the lack of local financial resources. Furthermore, the indigent have many other needs that cannot be addressed by exemption from user fees. Several knowledge transfer strategies were implemented to share research findings with residents and with local and national decision-makers.</p> <p>Partnership achievements and difficulties</p> <p>Using a mixed and interdisciplinary research approach was critical to grasping the complexity of this community-based process. The adoption of the process and the partnership with local decision-makers were very effective. Therefore, at the instigation of an NGO, four other districts in Burkina Faso and Niger reproduced this experiment. However, national decision-makers showed no interest in this action and still seem unconcerned about finding solutions that promote access to health care for the indigent.</p> <p>Lessons learned</p> <p>The lessons learned with regard to knowledge transfer and partnerships between researchers and associated decision-makers are: i) involve potential users of the research results from the research planning stage; ii) establish an ongoing partnership between researchers and users; iii) ensure that users can participate in certain research activities; iv) use a variety of strategies to disseminate results; and v) involve users in dissemination activities.</p

Persistent Submicroscopic Plasmodium falciparum Parasitemia 72 Hours after Treatment with Artemether-Lumefantrine Predicts 42-Day Treatment Failure in Mali and Burkina Faso.

A recent randomized controlled trial, the WANECAM (West African Network for Clinical Trials of Antimalarial Drugs) trial, conducted at seven centers in West Africa, found that artemether-lumefantrine, artesunate-amodiaquine, pyronaridine-artesunate, and dihydroartemisinin-piperaquine all displayed good efficacy. However, artemether-lumefantrine was associated with a shorter interval between clinical episodes than the other regimens. In a further comparison of these therapies, we identified cases of persisting submicroscopic parasitemia by quantitative PCR (qPCR) at 72 h posttreatment among WANECAM participants from 5 sites in Mali and Burkina Faso, and we compared treatment outcomes for this group to those with complete parasite clearance by 72 h. Among 552 evaluable patients, 17.7% had qPCR-detectable parasitemia at 72 h during their first treatment episode. This proportion varied among sites, reflecting differences in malaria transmission intensity, but did not differ among pooled drug treatment groups. However, patients who received artemether-lumefantrine and were qPCR positive at 72 h were significantly more likely to have microscopically detectable recurrent Plasmodium falciparum parasitemia by day 42 than those receiving other regimens and experienced, on average, a shorter interval before the next clinical episode. Haplotypes of pfcrt and pfmdr1 were also evaluated in persisting parasites. These data identify a possible threat to the parasitological efficacy of artemether-lumefantrine in West Africa, over a decade since it was first introduced on a large scale

Socializing One Health: an innovative strategy to investigate social and behavioral risks of emerging viral threats

In an effort to strengthen global capacity to prevent, detect, and control infectious diseases in animals and people, the United States Agency for International Development’s (USAID) Emerging Pandemic Threats (EPT) PREDICT project funded development of regional, national, and local One Health capacities for early disease detection, rapid response, disease control, and risk reduction. From the outset, the EPT approach was inclusive of social science research methods designed to understand the contexts and behaviors of communities living and working at human-animal-environment interfaces considered high-risk for virus emergence. Using qualitative and quantitative approaches, PREDICT behavioral research aimed to identify and assess a range of socio-cultural behaviors that could be influential in zoonotic disease emergence, amplification, and transmission. This broad approach to behavioral risk characterization enabled us to identify and characterize human activities that could be linked to the transmission dynamics of new and emerging viruses. This paper provides a discussion of implementation of a social science approach within a zoonotic surveillance framework. We conducted in-depth ethnographic interviews and focus groups to better understand the individual- and community-level knowledge, attitudes, and practices that potentially put participants at risk for zoonotic disease transmission from the animals they live and work with, across 6 interface domains. When we asked highly-exposed individuals (ie. bushmeat hunters, wildlife or guano farmers) about the risk they perceived in their occupational activities, most did not perceive it to be risky, whether because it was normalized by years (or generations) of doing such an activity, or due to lack of information about potential risks. Integrating the social sciences allows investigations of the specific human activities that are hypothesized to drive disease emergence, amplification, and transmission, in order to better substantiate behavioral disease drivers, along with the social dimensions of infection and transmission dynamics. Understanding these dynamics is critical to achieving health security--the protection from threats to health-- which requires investments in both collective and individual health security. Involving behavioral sciences into zoonotic disease surveillance allowed us to push toward fuller community integration and engagement and toward dialogue and implementation of recommendations for disease prevention and improved health security

Renal failure in cancer patients: results from the national cancer registry of Abidjan, Côte d’Ivoire

Background: Renal failure (RF) is a risk factor for morbidity and mortality in cancer patients. Objectives: To describe the profile of cancer patients with RF. Patients and Methods: This is a retrospective descriptive study of RF in patients enrolled in the national cancer registry of Abidjan, during the period from January 2012 to December 2015. The diagnosis of RF was confirmed based on a measured glomerular filtration rate (GFR) < 60 mL/min obtained using the Modification in Diet of Renal Disease (MDRD) formula. A comparison of patients with (n = 131) or without (n = 136) RF, followed by a logistic regression analysis, made it possible to identify the risk factors for RF. Results: The mean age was 54 ± 13.9 years in the group with RF versus 49 ± 14.8 years in the group without RF (P = 0.003). The etiologies of RF were urinary tract obstruction (41.2%), administration of platinum salts (19.8%) and water losses (12.2%). In multivariate analysis, age (P = 0.009), presence of hypertension (P = 0.02), uterine cancer (P = 0.0001) and prostate cancer (P = 0.014) were associated with the risk of RF in cancer patients. Factors such as male gender (P = 0.007), HIV infection (P = 0.021), GFR<15 mL/min (P = 0.002), and hemoglobin level <8 g/dL (P = 0.041) were associated with mortality in cancer patients with RF. Conclusions: Late diagnosis leads to renal complications with an increased risk of mortality

Molecular characterization of African Swine fever viruses in Burkina Faso, Mali, and Senegal 1989–2016

International audienceAfrican swine fever (ASF) has been endemic in sub-Saharan Africa since the 1960s. Following its introduction in Senegal, in 1957, ASF steadily progressed through West Africa, reaching Burkina Faso in 2003, and later Mali in 2016. Despite the heavy burden of disease on pig production, little information is available on the genetic diversity of Africa swine fever virus (ASFV) in Burkina Faso, Mali and Senegal. Here, we used real-time PCR ASFV to detect the ASFV genome in samples collected between 1989 and 2016, in Burkina Faso, Mali and Senegal, and conventional approaches for isolate characterization. The C-terminal end of the p72 protein gene, the full E183L gene and the central variable region (CVR) within the B602L gene in ASFV genome were sequenced and compared to publicly available sequences. ASFV genome was found in 27 samples, 19 from Burkina Faso, three from Mali and five from Senegal. The phylogenetic analyses showed that all viruses belong to genotype I, with the ASFVs from Burkina Faso and Mali grouping with genotype Ia and ASFV serogroup 4, and those from Senegal with genotype Ib and the ASFV serogroup 1. The analysis of the CVR tetrameric tandem repeat sequences (TRS) showed four TRS variants in Burkina Faso, two in Senegal and one in Mali. The three countries did not share any common TRS, and all CVRs of this study differed from previously reported CVRs in West Africa, except for Senegal. Three of the five isolates from Senegal fully matched with the CVR, p72 and p54 sequences from ASFV IC96 collected during the 1996 ASF outbreak in Ivory Coast. This study shows the spread of the same ASFV strains across countries, highlighting the importance of continuous m;onitoring of ASFV isolates. It also calls for an urgent need to establish a regional plan for the control and eradication of ASF in West Afric

Additional file 1 of Nutritional treatment of children 6–59 months with severely low weight-for-age z-score: a study protocol for a 3-arm randomized controlled trial

Additional file 1