Malaria Paediatrics
Conditions
Interventions
DP Placebo Group
Sponsors
Liverpool School of Tropical Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Infants from 2.5 months (10 weeks) whose parent/guardian has provided informed consent • No symptoms of malaria at the time of recruitment • Parent or guardian willing to adhere to study procedures including infant follow-up
Exclusion criteria
Exclusion criteria: Exclusion criteria • Known allergy or contraindication to any study drugs • Known HIV exposure • Pre-existing medical history of significant comorbidities that may influence drug exposure, e.g. renal, liver, gastrointestinal or cardiac diseases • Severe anaemia (haemoglobin (Hb) <7 g/dL) • Infant (breastfeeding mother) on medications that are known to have clinically significant interactions with DP • Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Age- and body-weight-related changes in pharmacokinetic properties of piperaquine (such as clearance and volume of distribution) in infants receiving IPTi-DP Association between the incidence of malaria and pharmacokinetic parameters. This will be achieved by comparing the Incidence of malaria from 2.5 months to 12 months of age, evaluated by comparing 1) DP exposed and unexposed infants and 2) primary pharmacokinetic parameters of piperaquine and the difference in piperaquine clearance (and other pharmacokinetic parameters such as trough concentrations) between infants who develop an episode of malaria and those who do not Recommendations for optimised DP dosing regimens for malaria intermittent preventive treatment in infants Safety and tolerability of IPTi-DP | — |
Secondary
| Measure | Time frame |
|---|---|
| Association between piperaquine pharmacokinetic exposure parameters and possible determinants of drug exposure such as nutritional status (weight for age z-score [WAZ], height for age [HAZ], weight for height z-score [WHZ], mid-upper arm circumference [MUAC]) and sex | — |
Countries
Malawi
Contacts
Public ContactClifford Banda
Site Principal Investigator
Outcome results
None listed