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Repeated doses of Praziquantel in Schistosomiasis Treatment (RePST) - single versus multiple praziquantel treatments in school-aged children in Cote d'Ivoire: a study protocol for an open-label, randomised controlled trial.

ABSTRACT: BACKGROUND:Large scale administration of the anthelminthic drug praziquantel (PZQ) to at-risk populations is the cornerstone of schistosomiasis control, although persisting high prevalence of infections in some areas and growing concerns of PZQ resistance have revealed the limitations of this strategy. Most studies assessing PZQ efficacy have used relatively insensitive parasitological diagnostics, such as the Kato-Katz (KK) and urine-filtration methods, thereby overestimating cure rates (CRs). This study aims to determine the efficacy of repeated PZQ treatments against Schistosoma mansoni infection in school-aged children in Côte d'Ivoire using the traditional KK technique, as well as more sensitive antigen- and DNA-detection methods. METHODS:An open-label, randomised controlled trial will be conducted in school-aged children (5 to 18?years) from the region of Taabo, Côte d'Ivoire, an area endemic for S. mansoni. This 8-week trial includes four two-weekly standard doses of PZQ in the "intense treatment" intervention group and one standard dose of PZQ in the "standard treatment" control group. The efficacy of PZQ will be evaluated in stool samples using the KK technique and real-time PCR as well as in urine using the point-of-care circulating cathodic antigen test and the up-converting phosphor, lateral flow, circulating anodic antigen assay. The primary outcome of the study will be the difference in CR of intense versus standard treatment with PZQ on individuals with a confirmed S. mansoni infection measured by KK. Secondary outcomes include the difference in CR and intensity reduction rate between the intense and standard treatment groups as measured by the other diagnostic tests, as well as the accuracy of the different diagnostic tests, and the safety of PZQ. DISCUSSION:This study will provide data on the efficacy of repeated PZQ treatment on the clearance of S. mansoni as measured by several diagnostic techniques. These findings will inform future mass drug administration policy and shed light on position of novel diagnostic tools to evaluate schistosomiasis control strategies. TRIAL REGISTRATION:The study is registered at EudraCT (2016-003017-10, date of registration: 22 July 2016) and ( NCT02868385 , date of registration: 16 August 2016).

SUBMITTER: Hoekstra PT

PROVIDER: S-EPMC6295059 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Project description:BACKGROUND:Preventive chemotherapy with praziquantel (PZQ) is the cornerstone of schistosomiasis control. However, a single dose of PZQ (40 mg/kg) does not cure all infections. Repeated doses of PZQ at short intervals might increase efficacy in terms of cure rate (CR) and intensity reduction rate (IRR). Here, we determined the efficacy of a single versus four repeated treatments with PZQ on Schistosoma mansoni infection in school-aged children from Côte d'Ivoire, using two different diagnostic tests. METHODS:An open-label, randomized controlled trial was conducted from October 2018 to January 2019. School-aged children with a confirmed S. mansoni infection based on Kato-Katz (KK) and point-of-care circulating cathodic antigen (POC-CCA) urine cassette test were randomly assigned to receive either a single or four repeated doses of PZQ, administered at two-week intervals. The primary outcome was the difference in CR between the two treatment arms, measured by triplicate KK thick smears 10 weeks after the first treatment. Secondary outcomes included CR estimated by POC-CCA, IRR by KK and POC-CCA, and safety of repeated PZQ administration. PRINCIPAL FINDINGS:During baseline screening, 1,022 children were assessed for eligibility of whom 153 (15%) had a detectable S. mansoni infection, and hence, were randomized to the standard treatment group (N = 70) and the intense treatment group (N = 83). Based on KK, the CR was 42% (95% confidence interval (CI) 31-52%) in the standard treatment group and 86% (95% CI 75-92%) in the intense treatment group. Observed IRR was 72% (95% CI 55-83%) in the standard treatment group and 95% (95% CI 85-98%) in the intense treatment group. The CR estimated by POC-CCA was 18% (95% CI 11-27%) and 36% (95% CI 26-46%) in the standard and intense treatment group, respectively. Repeated PZQ treatment did not result in a higher number of adverse events. CONCLUSION/SIGNIFICANCE:The observed CR using KK was significantly higher after four repeated treatments compared to a single treatment, without an increase in adverse events. Using POC-CCA, the observed CR was significantly lower than measured by KK, indicating that PZQ may be considerably less efficacious as concluded by KK. Our findings highlight the need for reliable and more accurate diagnostic tools, which are essential for monitoring treatment efficacy, identifying changes in transmission, and accurately quantifying the intensity of infection in distinct populations. In addition, the higher CR in the intense treatment group suggests that more focused and intense PZQ treatment can help to advance schistosomiasis control. TRIAL REGISTRATION:www.clinicaltrials.gov NCT02868385.

Project description:Over the past decade, a significant reduction in the prevalence of schistosomiasis has been achieved, partially explained by the large-scale administration of praziquantel. Yet, the burden of schistosomiasis remains considerable, and factors influencing intervention coverage are important. This study aimed to deepen the understanding of low treatment coverage rates observed in two schistosomiasis-endemic villages in Côte d'Ivoire. The research was conducted in August 2015, in Moronou and Bigouin, two villages of Côte d'Ivoire that are endemic for Schistosoma haematobium and S. mansoni, respectively. After completion of a clinical trial, standard praziquantel treatment (single 40 mg/kg oral dose) was offered to all village inhabitants by community health workers using a house-to-house approach. Factors influencing treatment coverage were determined by a questionnaire survey, randomly selecting 405 individuals. The overall treatment coverage rate was only 47.6% (2730/5733) with considerable intervillage heterogeneity (27.7% in Bigouin (302/1091) versus 52.3% in Moronou (2428/4642)). Among the 200 individuals interviewed in Moronou, 50.0% were administered praziquantel, while only 19.5% of the 205 individuals interviewed in Bigouin received praziquantel. The main reasons for low treatment coverage were work-related (agricultural activities), the bitter taste of praziquantel and previous experiences with adverse events. The most suitable period for treatment campaigns was reported to be the dry season. More than three-quarter of the interviewees who had taken praziquantel (overall, 116/140; Moronou, 84/100; Bigouin, 32/40) declared that they would not participate in future treatments (p < 0.001). In order to enhance praziquantel treatment coverage, careful consideration should be given to attitudes and practices, such as prior or perceived adverse events and taste of praziquantel, and appropriate timing, harmonized with agricultural activities. Without such understanding, breaking the transmission of schistosomiasis remains a distant goal.

Project description:BackgroundThe Schistosomiasis Consortium for Operational Research and Evaluation (SCORE) has launched several large-scale trials to determine the best strategies for gaining and sustaining control of schistosomiasis and transitioning toward elimination. In Côte d'Ivoire, a 5-year cluster-randomized trial is being implemented in 75 schools to sustain the control of schistosomiasis mansoni. We report Schistosoma mansoni infection levels in children one year after the initial school-based treatment (SBT) with praziquantel and compare with baseline results to determine the effect of the intervention.MethodologyThe baseline cross-sectional survey was conducted in late 2011/early 2012 and the first follow-up in May 2013. Three consecutive stool samples were collected from 9- to 12-year-old children in 75 schools at baseline and 50 schools at follow-up. Stool samples were subjected to duplicate Kato-Katz thick smears. Directly observed treatment (DOT) coverage of the SBT was assessed and the prevalence and intensity of S. mansoni infection compared between baseline and follow-up.Principal findingsThe S. mansoni prevalence in the 75 schools surveyed at baseline was 22.1% (95% confidence interval (CI): 19.5-24.4%). The DOT coverage was 84.2%. In the 50 schools surveyed at baseline and one year after treatment, the overall prevalence of S. mansoni infection decreased significantly from 19.7% (95% CI: 18.5-20.8%) to 12.8% (95% CI: 11.9-13.8%), while the arithmetic mean S. mansoni eggs per gram of stool (EPG) among infected children slightly increased from 92.2 EPG (95% CI: 79.2-105.3 EPG) to 109.3 EPG (95% CI: 82.7-135.9 EPG). In two of the 50 schools, the prevalence increased significantly, despite a DOT coverage of >75%.Conclusions/significanceOne year after the initial SBT, the S. mansoni prevalence had decreased. Despite this positive trend, an increase was observed in some schools. Moreover, the infection intensity among S. mansoni-infected children was slightly higher at the 1-year follow-up compared to the baseline situation. Our results emphasize the heterogeneity of transmission dynamics and provide a benchmark for the future yearly follow-up surveys of this multi-year SCORE intervention study.

Project description:BackgroundSchistosomiasis and soil-transmitted helminthiasis are important public health problems in sub-Saharan Africa causing malnutrition, anemia, and retardation of physical and cognitive development. However, the effect of these diseases on physical fitness remains to be determined.MethodologyWe investigated the relationship between schistosomiasis, soil-transmitted helminthiasis and physical performance of children, controlling for potential confounding of Plasmodium spp. infections and environmental parameters (i.e., ambient air temperature and humidity). A cross-sectional survey was carried out among 156 school children aged 7-15 years from Côte d'Ivoire. Each child had two stool and two urine samples examined for helminth eggs by microscopy. Additionally, children underwent a clinical examination, were tested for Plasmodium spp. infection with a rapid diagnostic test, and performed a maximal multistage 20 m shuttle run test to assess their maximal oxygen uptake (VO(2) max) as a proxy for physical fitness.Principal findingsThe prevalence of Schistosoma haematobium, Plasmodium spp., Schistosoma mansoni, hookworm and Ascaris lumbricoides infections was 85.3%, 71.2%, 53.8%, 13.5% and 1.3%, respectively. Children with single, dual, triple, quadruple and quintuple species infections showed VO(2) max of 52.7, 53.1, 52.2, 52.6 and 55.6 ml kg(-1) min(-1), respectively. The VO(2) max of children with no parasite infections was 53.5 ml kg(-1) min(-1). No statistically significant difference was detected between any groups. Multivariable analysis revealed that VO(2) max was influenced by sex (reference: female, coef.?=?4.02, p<0.001) and age (years, coef.?=?-1.23, p<0.001), but not by helminth infection and intensity, Plasmodium spp. infection, and environmental parameters.Conclusion/significanceSchool-aged children in Côte d'Ivoire showed good physical fitness, irrespective of their helminth infection status. Future studies on children's physical fitness in settings where helminthiasis and malaria co-exist should include pre- and post-intervention evaluations and the measurement of hemoglobin and hematocrit levels and nutritional parameters as potential co-factors to determine whether interventions further improve upon fitness.

Project description:BACKGROUND:Schistosomiasis is a water-based disease transmitted by trematodes belonging to the genus Schistosoma. The aim of this study was to assess the relationship between the prevalence of schistosomiasis and access to water, sanitation and hygiene (WASH) and environmental and socioeconomic factors in the city of Korhogo, northern Côte d'Ivoire. METHODS:A cross-sectional study including 728 randomly selected households was conducted in Korhogo in March 2015. The heads of the households were interviewed about access to WASH and environmental and socioeconomic factors. All children abed between 5 and 15 years living in the households were selected to provide stool and urine samples for parasitological diagnosis of Schistosoma mansoni and Schistosoma haematobium infection. The relationship between infection with S. mansoni and potential risk factors was analysed by a mixed logistic regression model with 'household' as a random factor. Likelihood ratio tests were used to identify factors that were significantly associated with a Schistosoma spp. infection. RESULTS:The overall prevalence of schistosomiasis among school-aged children in Korhogo was 1.9% (45/2341) composed of 0.3% (3/1248) S. haematobium and 3.5% (42/1202) S. mansoni. Due to the low prevalence of S. haematobium infection, risk factor analysis was limited to S. mansoni. Boys were 7.8 times more likely to be infected with S. mansoni than girls. Children between 10 and 15 years of age were 3.8 times more likely to be infected than their younger counterparts aged 5-10 years. Moreover, living in a house further away from a water access point (odds ratio [OR]?=?0.29, 95% confidence interval [CI]: 0.13-0.70) and abstaining from swimming in open freshwater bodies (OR?=?0.16, 95% CI: 0.04-0.56) were significantly associated with decreased odds of S. mansoni infection. The socioeconomic status did not appear to influence the prevalence of S. mansoni. CONCLUSIONS:A strategy to reduce the incidence of schistosomiasis should focus on health education to change the behaviour of populations at risk and encourage communities to improve sanitation and infrastructure in order to reduce contact with surface water.

Project description:BackgroundSchistosomiasis is a serious public health burden in sub-Saharan Africa. Praziquantel is the only drug recommended by the World Health Organization to treat both urogenital and intestinal schistosomiasis. The reliance on a single drug to treat a disease with such a huge burden has raised concerns of possible drug resistance mainly in endemic areas. This systematic review was conducted to identify gaps and recent progress on the efficacy of different regimens of praziquantel in treating schistosomiasis among children in sub-Saharan Africa where Schistosoma mansoni and S. haematobium are endemic.Main textA literature search of peer-reviewed journals was done on Google Scholar, MEDLINE (under EBSCOhost) and PubMed databases using pre-defined search terms and Boolean operators. The search included studies published from 2008 to 2017 (August) with emphasis on the efficacy of praziquantel on S. haematobium and S. mansoni infections among preschool and school children. Nineteen publications satisfied the inclusion criteria for the review. The studies reviewed were from 10 sub-Saharan African countries and 7/19 of the studies (37%) were conducted in Uganda. Seven studies (37%) focused on Schistosoma mansoni, 6/19 (31.5%) on S. haematobium and another 6 on mixed infection. A single standard dose of 40 mg/kg body weight was the most used regimen (9) followed by the repeated single standard dose assessed for efficacy at 3-4 weeks post-treatment.ConclusionsA repeated standard dose of 40 mg/kg achieved satisfactory efficacy compared to a single dose against both parasite species. However, findings on efficacy of repeated doses in co-infection of S. mansoni and S. haematobium were not conclusive. Praziquantel administrated at 60 mg/kg was slightly more efficacious than the 40 mg/kg standard dose. Minor and transitory side-effects were reported for both regimens. The review indicates that further investigations are necessary to conclusively determine efficacy of praziquantel on coinfection of S. haematobium and S. mansoni to formulate concrete guidelines on the use of repeated doses at 40 or 60 mg/kg for treating schistosomiasis. We recommend the use of the egg reduction rate (ERR) formula recommended by the WHO for assessing praziquantel efficacy in order for the results to be comparable for different regions.

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Repeated doses of Praziquantel in Schistosomiasis Treatment (RePST) - single versus multiple praziquantel treatments in school-aged children in Cote d'Ivoire: a study protocol for an open-label, randomised controlled trial.

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