BackgroundChild health in many low- and middle-income countries lags behind international goals and affects children’s education, well-being, and general development. Large-scale school health programmes can be effective in reducing preventable diseases through cost-effective interventions. This paper outlines the baseline and 1-year results of a longitudinal health study assessing the impact of the Fit for School Programme in the Philippines.MethodsA longitudinal 4-year cohort study was conducted in the province of Camiguin, Mindanao (experimental group); an external concurrent control group was studied in Gingoog, Mindanao. The study has three experimental groups: group 1—daily handwashing with soap, daily brushing with fluoride toothpaste, biannual deworming with 400 mg albendazole (Essential Health Care Program [EHCP]); group 2—EHCP plus twice-a-year access to school-based Oral Urgent Treatment; group 3—EHCP plus weekly toothbrushing with high-fluoride concentration gel. A non-concurrent internal control group was also included. Baseline data on anthropometric indicators to calculate body mass index (BMI), soil-transmitted helminths (STH) infection in stool samples, and dental caries were collected in August 2009 and August 2010. Data were analysed to assess validity of the control group design, baseline, and 1-year results.ResultsIn the cohort study, 412 children were examined at baseline and 341 1 year after intervention. The baseline results were in line with national averages for STH infection, BMI, and dental caries in group 1 and the control groups. Children lost to follow-up had similar baseline characteristics in the experimental and control groups. After 1 year, group 1 showed a significantly higher increase in mean BMI and lower prevalence of moderate to heavy STH infection than the external concurrent control group. The increases in caries and dental infections were reduced but not statistically significant. The results for groups 2 and 3 will be reported separately.ConclusionsDespite the short 1-year observation period, the study found a reduction in the prevalence of moderate to heavy STH infections, a rise in mean BMI, and a (statistically non-significant) reduction in dental caries and infections. The study design proved functional in actual field conditions. Critical aspects affecting the validity of cohort studies are analysed and discussed.Trial registrationDRKS00003431 WHO Universal Trial Number U1111-1126-0718

BackgroundPraziquantel at 40 mg/kg in a single dose is the WHO recommended treatment for all forms of schistosomiasis, but 60 mg/kg is also deployed nationally.Methodology/Principal FindingsFour trial sites in the Philippines, Mauritania, Tanzania and Brazil enrolled 856 patients using a common protocol, who were randomised to receive praziquantel 40 mg/kg (n = 428) or 60 mg/kg (n = 428). While the sites differed for transmission and infection intensities (highest in Tanzania and lowest in Mauritania), no bias or heterogeneity across sites was detected for the main efficacy outcomes. The primary efficacy analysis was the comparison of cure rates on Day 21 in the intent-to-treat population for the pooled data using a logistic model to calculate Odd Ratios allowing for baseline characteristics and study site. Both doses were highly effective: the Day 21 cure rates were 91.7% (86.6%–98% at individual sites) with 40 mg/kg and 92.8% (88%–97%) with 60 mg/kg. Secondary parameters were eggs reduction rates (ERR), change in intensity of infection and reinfection rates at 6 and 12 months. On Day 21 the pooled estimate of the ERR was 91% in both arms. The Hazard Ratio for reinfections was only significant in Brazil, and in favour of 60 mg/kg on the pooled estimate (40 mg/kg: 34.3%, 60 mg/kg: 23.9%, HR = 0.78, 95%CI = [0.63;0.96]). Analysis of safety could not distinguish between disease- and drug-related events. 666 patients (78%) reported 1327 adverse events (AE) 4 h post-dosing. The risk of having at least one AE was higher in the 60 than in the 40 mg/kg group (83% vs. 73%, p<0.001). At 24 h post-dosing, 456 patients (54%) had 918 AEs with no difference between arms. The most frequent AE was abdominal pain at both 4 h and 24 h (40% and 24%).ConclusionA higher dose of 60 mg/kg of praziquantel offers no significant efficacy advantage over standard 40 mg/kg for treating intestinal schistosomiasis caused by either S. mansoni or S. japonicum. The results of this study support WHO recommendation and should be used to inform policy decisions in the countries.Trial Registration Controlled-Trials.com ISRCTN29273316 ClinicalTrials.gov NCT00403611

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