Does increasing the biltricide (praziquantel) treatment frequency reduce liver damage in children?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2019
INTERVENTION: This trial is designed to align with the national Uganda Neglected Tropical Disease Control Programme, Mass Drug Administration with Praziquantel, (MDA) which is a public health programme. The public health programme is delivered annually through the primary schools and the control arm for this trial mimics the annual public health programme. The IMP is Praziquantel, the dose is 40mg/kg, dependent on standardised and verified dose pole. This is the method used to determine dose for the MDA. Maximum dose 5x600mg tablets. The IMP is given orally after food. Children who are treated with praziquantel will be directly observed for 1‐hour with follow‐up the next day. Total treatments detailed below include an end of trial final treatment. The trial runs over 50 months: the treatment period over two years. Randomisation will be stratified by school. Individuals will be randomised on a 1:1:1 ratio into the control or intervention arms. Six hundred primary school‐aged children will be enrolled in the study and 200 randomised into each of the three arms. Assessments during the trail: 2 x 3 day‐annual screening period for S. mansoni egg counts and ultrasonography examination. The Ultrasound Examination and the collection of stool samples will be collected up‐to 2‐weeks prior to treatment with praziquantel. 3 x 3 day‐annual 4‐week follow up screen for S. mansoni egg counts. Stool samples will be collected at 4‐weeks post treatment to assess treatment efficacy. Intervention period: Control arm: 3 treatments of Praziquantel, provided annually. Intervention arm 1: 5 treatments, provided bi‐annually at 6 months apart Intervention arm 2: 9 treatments, provided quarterly at 3 months apart. Timings of treatments are shown in the Schedule of Assessments. Their exact timing is dependent on the timin CONDITION: Periportal fibrosis of the liver caused by schistsosomiasis mansoni ; Digestive System ; Hepatic fibrosis PRIMARY OUTCOME: Prevalence of periportal fibrosis, defined as Niamey Protocol pattern scores of C,D,E or F, measured at 2‐years follow‐up. SECONDARY OUTCOME: Schistosoma mansoni infection intensities are measured using Kato‐Katz faecal egg counts (28) at 2‐years follow‐up. INCLUSION CRITERIA: 1. Have a parent/guardian who has given written/marked informed consent for the child to participate. 2. Given written/marked informed assent to participate. 3. Aged 6‐14 years of age. 4. Born or resident within the community in which their school is situated for >=2 years.
Epistemonikos ID: e380c76b35c4c990ace04ea031b8e32bcba032fa
First added on: Aug 24, 2024