ArticleTrials2021
The praziquantel in preschoolers (PIP) trial: study protocol for a phase II PK/PD-driven randomised controlled trial of praziquantel in children under 4 years of age.
Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03640377 (Phase II PK/PD Driven Dose Finding Trial of Praziquantel in Children Under Four), which is not on this map. Cited by 10 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II PK/PD Driven Dose Finding Trial of Praziquantel in Children Under Four
Who cites it
10 citing papers in PubMed, 16 citations in OpenAlex.
- Article
- Identification of training needs in schistosomiasis research to build capacity for schistosomiasis control in Uganda.Tropical medicine & international health : TM & IH · 2025Article
- Effect of Praziquantel Treatment on the Nutritional Status of Children Infected withPathogens (Basel, Switzerland) · 2025Article
- Schistosomiasis in the Philippines: A Comprehensive Review of Epidemiology and Current Control.Tropical medicine and infectious disease · 2025Review
- Associations of poor water, sanitation, and hygiene and parasite burden with markers of environmental enteric dysfunction in preschool-age children infected with Schistosoma mansoni in Uganda.Tropical medicine & international health : TM & IH · 2025Article
- A Recent Advance in the Diagnosis, Treatment, and Vaccine Development for Human Schistosomiasis.Tropical medicine and infectious disease · 2024Review
- A cross-sectional pilot household study of Schistosoma mansoni burden and associated morbidities in Lake Albert, Uganda.Tropical medicine & international health : TM & IH · 2024Article
- Relationships Between Schistosoma mansoni Infection Intensity and Nutritional Status and Anemia Among Preschool-aged Children in Uganda.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2024Article
- Drugs for neglected tropical diseases: availability of age-appropriate oral formulations for young children.Parasites & vectors · 2022Review
- Safety of integrated preventive chemotherapy for neglected tropical diseases.PLoS neglected tropical diseases · 2022Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 4 institutions in 3 countries.
Funding
Abstract
backgroundOver 200 million individuals worldwide are infected with Schistosoma species, with over half of infections occurring in children. Many children experience first infections early in life and this impacts their growth and development; however praziquantel (PZQ), the drug used worldwide for the treatment of schistosomiasis, only has regulatory approval among adults and children over the age of four, although it is frequently used "off label" in endemic settings. Furthermore, pharmacokinetic/pharmacodynamics (PK/PD) evidence suggests the standard PZQ dose of 40 mg/kg is insufficient in preschool-aged children (PSAC). Our goal is to understand the best approaches to optimising the treatment of PSAC with intestinal schistosomiasis.
methodsWe will conduct a randomised, controlled phase II trial in a Schistosoma mansoni endemic region of Uganda and a Schistosoma japonicum endemic region of the Philippines. Six hundred children, 300 in each setting, aged 12-47 months with Schistosoma infection will be randomised in a 1:1:1:1 ratio to receive either (1) 40 mg/kg PZQ at baseline and placebo at 6 months, (2) 40 mg/kg PZQ at baseline and 40 mg/kg PZQ at 6 months, (3) 80 mg/kg PZQ at baseline and placebo at 6 months, or (4) 80 mg/kg PZQ at baseline and 80 mg/kg PZQ at 6 months. Following baseline treatment, children will be followed up for 12 months. The co-primary outcomes will be cure rate and egg reduction rate at 4 weeks. Secondary outcomes include drug efficacy assessed by novel antigenic endpoints at 4 weeks, actively collected adverse events and toxicity for 12 h post-treatment, morbidity and nutritional outcomes at 6 and 12 months, biomarkers of inflammation and environmental enteropathy and PZQ PK/PD parameters. DISCUSSION: The trial will provide valuable information on the safety and efficacy of the 80 mg/kg PZQ dose in PSAC, and on the impact of six-monthly versus annual treatment, in this vulnerable age group.
trial registrationClinicalTrials.gov NCT03640377 . Registered on 21 Aug 2018.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.