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Efficacy and safety of arachidonic acid for treatment of school-age children in Schistosoma mansoni high-endemicity regions.

ABSTRACT: Arachidonic acid (ARA), an omega-6 fatty acid, is a potent schistosomicide that displayed significant and safe therapeutic effects in Schistosoma mansoni-infected schoolchildren in S. mansoni low-prevalence regions. We here report on ARA efficacy and safety in treatment of schoolchildren in S. mansoni high-endemicity areas of Kafr El Sheikh, Egypt. The study was registered with ClinicalTrials.gov (NCT02144389). In total, 268 schoolchildren with light, moderate, or heavy S. mansoni infection were assigned to three study arms of 87, 91, and 90 children and received a single dose of 40 mg/kg praziquantel (PZQ), ARA (10 mg/kg per day for 15 days), or PZQ combined with ARA, respectively. The children were examined before and after treatment for stool parasite egg counts and blood biochemical, hematological, and immunological parameters. ARA, like PZQ, induced moderate cure rates (50% and 60%, respectively) in schoolchildren with light infection and modest cure rates (21% and 20%, respectively) in schoolchildren with high infection. PZQ and ARA combined elicited 83% and 78% cure rates in children with light and heavy infection, respectively. Biochemical and immunological profiles were either unchanged or ameliorated after ARA therapy. Combination of PZQ and ARA might be useful for treatment of children with schistosomiasis in high-endemicity regions.

SUBMITTER: Barakat R

PROVIDER: S-EPMC4385776 | biostudies-literature | 2015 Apr

REPOSITORIES: biostudies-literature

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Efficacy and safety of arachidonic acid for treatment of school-age children in Schistosoma mansoni high-endemicity regions.

Barakat Rashida R Abou El-Ela Nadia E NE Sharaf Soraya S El Sagheer Ola O Selim Sahar S Tallima Hatem H Bruins Maaike J MJ Hadley Kevin B KB El Ridi Rashika R

The American journal of tropical medicine and hygiene 20150126 4

Arachidonic acid (ARA), an omega-6 fatty acid, is a potent schistosomicide that displayed significant and safe therapeutic effects in Schistosoma mansoni-infected schoolchildren in S. mansoni low-prevalence regions. We here report on ARA efficacy and safety in treatment of schoolchildren in S. mansoni high-endemicity areas of Kafr El Sheikh, Egypt. The study was registered with ClinicalTrials.gov (NCT02144389). In total, 268 schoolchildren with light, moderate, or heavy S. mansoni infection were ...[more]

PMID: 25624403

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Project description:BackgroundAnnual mass drug administration with praziquantel has reduced schistosomiasis transmission in some highly endemic areas, but areas with persistent high endemicity have been identified across sub-Saharan Africa, including Uganda. In these areas many children are rapidly reinfected post treatment, while some children remain uninfected or have low-intensity infections. The aim of this mixed-methods study was to better understand variation in water contact locations, behaviours and infection risk in school-aged children within an area with persistent high endemicity to inform additional control efforts.MethodsData were collected in Bugoto, Mayuge District, Uganda. Two risk groups were identified from a longitudinal cohort, and eight children with no/low-intensity infections and eight children with reinfections were recruited. Individual structured day-long observations with a focus on water contact were conducted over two periods in 2018. In all identified water contact sites, four snail surveys were conducted quarterly over 1 year. All observed Biomphalaria snails were collected, counted and monitored in the laboratory for Schistosoma mansoni cercarial shedding for 3 weeks.ResultsChildren came into contact with water for a range of purposes, either directly at the water sources or by coming into contact with water collected previously. Although some water contact practices were similar between the risk groups, only children with reinfection were observed fetching water for commercial purposes and swimming in water sources; this latter group of children also came into contact with water at a larger variety and number of sites compared to children with no/low-intensity infection. Households with children with no/low-intensity infections collected rainwater more often. Water contact was observed at 10 sites throughout the study, and a total of 9457 Biomphalaria snails were collected from these sites over four sampling periods. Four lake sites had a significantly higher Biomphalaria choanomphala abundance, and reinfected children came into contact with water at these sites more often than children with no/low-intensity infections. While only six snails shed cercariae, four were from sites only contacted by reinfected children.ConclusionsChildren with reinfection have more high-risk water contact behaviours and accessed water sites with higher B. choanomphala abundance, demonstrating that specific water contact behaviours interact with environmental features to explain variation in risk within areas with persistent high endemicity. Targeted behaviour change, vector control and safe water supplies could reduce reinfection in school-aged children in these settings.

Project description:BackgroundPraziquantel has been the drug of choice for schistosomiasis control for more than 40 years, yet surprisingly, the optimal dose for children younger than 4 years is not known. We aimed to assess the efficacy and safety of escalating praziquantel dosages in preschool-aged children (PSAC).MethodsWe did a randomised controlled, parallel-group, single-blind, dose-ranging, phase 2 trial in PSAC (2-5 years) and school-aged children (SAC; aged 6-15 years) as a comparator group in southern Côte d'Ivoire. Children were randomly assigned (1:1:1:1) to 20 mg/kg, 40 mg/kg, or 60 mg/kg praziquantel or placebo. Participants, investigators, and laboratory technicians were masked to group assignment, while the investigator providing treatment was aware of the treatment group. The primary objective was to estimate the nature of the dose-response relation in terms of cure rate using the Kato Katz technique. Dose-response curves were estimated using Emax models. Available case analysis was done including all participants with primary endpoint data. This trial is registered with International Standard Randomised Controlled Trial, number ISRCTN15280205.FindingsBetween Nov 11, 2014, and Feb 18, 2015, 660 PSAC and 225 SAC were assessed for eligibility; of whom 161 (24%) PSAC and 180 (80%) SAC had a detectable Schistosoma mansoni infection. 161 PSAC were randomly allocated of whom 154 received treatment: 42 were assigned to 20 mg/kg praziquantel, of whom 40 received treatment; 38 were assigned to 40 mg/kg praziquantel, of whom 38 received treatment; 41 were assigned to 60 mg/kg praziquantel, of whom 39 received treatment; and 40 were assigned to placebo, of whom 37 received placebo. 180 SAC were randomly allocated of whom 177 received treatment: 49 were assigned to 20 mg/kg praziquantel, of whom 47 received treatment; 46 were assigned to 40 mg/kg praziquantel, of whom 46 received treatment; 42 were assigned to 60 mg/kg praziquantel, of whom 42 received treatment; and 43 were assigned to placebo, of whom 43 received treatment. Follow-up (available-case) data were available for 143 PSAC and 174 SAC. In PSAC, the 20 mg/kg dose resulted in cure in 23 children (62%; 95% CI 44·8-77·5), 40 mg/kg in 26 children (72%; 54·8-85·8), 60 mg/kg in 25 children (71%; 53·7-85·4), and placebo in 13 children (37%; 21·5-55·1). In SAC, the 20 mg/kg dose resulted in cure in 14 children (30%; 95% CI 17·7-45·8), 40 mg/kg in 31 children (69%; 53·4-81·8), 60 mg/kg in 34 children (83%; 67·9-92·8), and placebo in five children (12%; 4·0-25·6). For both age groups, the number of adverse events was similar among the three praziquantel treatment groups, with fewer adverse events observed in the placebo groups. The most common adverse events in PSAC were diarrhoea (11 [9%] of 124) and stomach ache (ten [8%]) and in SAC were diarrhoea (50 [28%] of 177), stomach ache (66 [37%]), and vomiting (26 [15%]) 3 h post treatment. No serious adverse events were reported.InterpretationPraziquantel shows a flat dose-response and overall lower efficacy in PSAC compared with in SAC. In the absence of treatment alternatives, a single dose of praziquantel of 40 mg/kg, recommended by the WHO for S mansoni infections in SAC can be endorsed for PSAC in preventive chemotherapy programmes.FundingEuropean Research Council.

Project description:BACKGROUND:Head lice most commonly affect children, ages 3 to 11. Concerns exist about the safety and efficacy of pesticide-based treatments. Published studies suggest dimethicone is a potentially safe and effective non-toxic treatment, but have not evaluated 100% dimethicone in a pediatric population. The objectives were to evaluate the efficacy and safety of 100% dimethicone for the treatment of head lice in children, monitored by school nurses. METHODS:This was a multi-site, open-label study of a 100% dimethicone gel for the treatment of head lice in a pediatric population. Children (ages 3-12) suspected of infestation with head lice were evaluated by school nurses at six schools and daycare programs in New York and New Jersey. Inclusion criteria were presence of at least three live lice, or one live louse and 10 viable eggs (eggs found within 1.27 cm of the scalp) and no use of any head lice treatment within four weeks of enrollment. Counts of live lice and viable eggs found in 58 subjects were tracked at baseline (Day 0) and on Day 1, Day 7, and Day 14 after treatment. RESULTS:After 1 day of treatment with 100% dimethicone, 98.30% of subjects were free of live lice and 55.20% were free of viable eggs. On day 14, 96.50% were still free of live lice, and 80.70% were free of viable eggs. All subjects were monitored by the school nurse at baseline and throughout the study period for adverse effects, including scalp erythema, excoriation, flaking and edema. There was one adverse event of skin irritation lasting 10 min, and no serious adverse events reported. Overall, scalp conditions improved from the baseline: 10 subjects (17.5%) reported mild to moderate scalp erythema on day 1, compared with only one subject (1.7%) on day 14; 8 subjects (14.3%) reported mild scalp excoriation on day 1, with none reporting on day 14. CONCLUSIONS:100% dimethicone was found to be a safe and highly effective treatment for pediatric head lice. Because dimethicone avoids pesticide exposure and resistance issues, dimethicone should be considered as a first-line treatment for head lice. TRIAL REGISTRATION:NCT02213055 Date of registration: August 8, 2014. STANDARDS OF REPORTING: The CONSORT 2010 Checklist was consulted during the review of this manuscript. Please note that sections pertaining specifically to randomized controlled trials (RCT's) were not applicable.

Project description:BackgroundFrom 2011 to 2015, seven trachoma impact surveys in 150 districts across Amhara, Ethiopia, included in their design a nested study to estimate the zonal prevalence of intestinal parasite infections including soil-transmitted helminths (STH) and Schistosoma mansoni.MethodsA multi-stage cluster random sampling approach was used to achieve a population-based sample of children between the ages of 6 and 15 years. Stool samples of approximately 1 g were collected from assenting children, preserved in 10 ml of a sodium acetate-acetic acid-formalin solution, and transported to the Amhara Public Health Research Institute for processing with the ether concentration method and microscopic identification of parasites. Bivariate logistic and negative binomial regression were used to explore associations with parasite prevalence and intensity, respectively.ResultsA total of 16,955 children were selected within 768 villages covering 150 districts representing all ten zones of the Amhara region. The final sample included 15,455 children of whom 52% were female and 75% reported regularly attending school. The regional prevalence among children of 6 to 15 years of age was 36.4% (95% confidence interval, CI: 34.9-38.0%) for any STH and 6.9% (95% CI: 5.9-8.1%) for S. mansoni. The zonal prevalence of any STH ranged from 12.1 to 58.3%, while S. mansoni ranged from 0.5 to 40.1%. Categories of risk defined by World Health Organization guidelines would indicate that 107 districts (71.3%) warranted preventive chemotherapy (PC) for STH and 57 districts (38.0%) warranted PC for schistosomiasis based solely on S. mansoni. No statistical differences in the prevalence of these parasites were observed among boys and girls, but age and school attendance were both associated with hookworm infection (prevalence odds ratio, POR: 1.02, P = 0.03 per 1 year, and POR: 0.81, P = 0.001, respectively) and age was associated with infection by any STH (POR: 1.02, P = 0.03). Age was also associated with reduced intensity of Ascaris lumbricoides infection (unadjusted rate ratio: 0.96, P = 0.02) and increased intensity of hookworm infection (unadjusted rate ratio: 1.07, P < 0.001).ConclusionsThese surveys determined that between 2011 and 2015, STH and Schistosoma mansoni were present throughout the region, and accordingly, these results were used to guide PC distribution to school-age children in Amhara.

Project description:BackgroundIn sub-Saharan Africa the recommended strategy to control schistosomiasis is preventive chemotherapy. Emphasis is placed on school-aged children, but in high endemicity areas, preschool-aged children are also at risk, and hence might need treatment with praziquantel. Since a pediatric formulation (e.g., syrup) is not available outside of Egypt, crushed praziquantel tablets are used, but the efficacy and safety of this treatment regimen is insufficiently studied.MethodologyWe assessed the efficacy and safety of crushed praziquantel tablets among preschool-aged children (<6 years) in the Azaguié district, south Côte d'Ivoire, where Schistosoma mansoni and S. haematobium coexist. Using a cross-sectional design, children provided two stool and two urine samples before and 3 weeks after treatment. Crushed praziquantel tablets, mixed with water, were administered at a dose of 40 mg/kg. Adverse events were assessed and graded 4 and 24 hours posttreatment by interviewing mothers/guardians.Principal findingsOverall, 160 preschool-aged children had at least one stool and one urine sample examined with duplicate Kato-Katz thick smears and a point-of-care circulating cathodic antigen (POC-CCA) cassette for S. mansoni, and urine filtration for S. haematobium diagnosis before and 3 weeks after praziquantel administration. According to the Kato-Katz and urine filtration results, we found high efficacy against S. mansoni (cure rate (CR), 88.6%; egg reduction rate (ERR), 96.7%) and S. haematobium (CR, 88.9%; ERR, 98.0%). POC-CCA revealed considerably lower efficacy against S. mansoni (CR, 53.8%). Treatment was generally well tolerated, but moderately severe adverse events (i.e., body and face inflammation), were observed in four Schistosoma egg-negative children.Conclusions/significanceCrushed praziquantel administered to preschool-aged children at a dose of 40 mg/kg is efficacious against S. mansoni and S. haematobium in a co-endemic setting of Côte d'Ivoire. Further research is required with highly sensitive diagnostic tools and safety must be investigated in more depth.Trial registrationControlled-Trials.com ISRCTN53172722.

Dataset Information

Efficacy and safety of arachidonic acid for treatment of school-age children in Schistosoma mansoni high-endemicity regions.

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Efficacy and safety of arachidonic acid for treatment of school-age children in Schistosoma mansoni high-endemicity regions.

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