Praziquantel in Children Under Age 4 (PIPS)
Schistosomiasis, Schistosomiasis Mansoni, Schistosoma Japonicum Infection
About this trial
This is an interventional treatment trial for Schistosomiasis
Eligibility Criteria
Inclusion Criteria:
- S. japonicum or S. mansoni infection by urine CCA
- Otherwise healthy as determined by history and physical examination conducted by the study physician at the second stage screening
- Age 12-48 months inclusive
- Parental consent to participate.
Exclusion Criteria:
- Parental inability to provide informed consent
- Significant disease/illness as determined by history or physical exam. This includes a severe acute illness or chronic disease as defined by greater than 3 months duration and significantly impacting a child's daily activities.
- Severe wasting as defined by WHZ < -3,
- Severe anemia (hemoglobin < 7 g/dL)
- Exposure to immuno-modulatory therapeutics.
Sites / Locations
- Medical Research CouncilRecruiting
- London School of Tropical Hygiene and Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Praziquantel 40 mg/kg dose only baseline treatment
Praziquantel 80 mg/kg dose only baseline treatment
Praziquantel 40 mg/kg dose at baseline and 6 months
Praziquantel 80 mg/kg dose at baseline and 6 months
150 children will receive 40 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
150 children will receive 80 mg/kg Praziquantel at baseline as single treatment and placebo six months following baseline
150 children will receive 40 mg/kg Praziquantel at baseline and again six months later.
150 children will receive 80 mg/kg Praziquantel at baseline and again six months later.