Malaria
Conditions
Interventions
Artavol
Dihydroartemisini piperaquine
Sponsors
Science Technology and Innovation secretariat office of the president
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A public, day primary school located in Kibuku district which has provided written consent to participate in the study. 2. A participant will be eligible for enrolment in the Phase 2B clinical trial if he or she satisfies the following criteria: I. Aged 8-15 years II. Informed consent obtained from parent/legal guardian. III. Assent obtained from children from 8-15 years of age. IV. Residents in Kibuku district. V. Parents/guardians and participants willing to adhere to the study procedures and follow-up periods. VI. Willing to provide locator information and to be contacted during the course of the trial.
Exclusion criteria
Exclusion criteria: The study will exclude primary schools for children with special needs, and those already enrolled in other interventional studies. A participant who meets the above inclusion criteria will not be enrolled in this study if he or she has;Known allergy or adverse reaction to artemisinin-based regimens or study drug II. Ongoing antimalarial treatment or receiving routine malaria prophylaxis e.g. for Sickle cell disease (SCD) or those routinely taking other malaria chemopreventive herbs III. Physical evidence of abnormal organ function including renal, hepatic, and haematological IV. Positive pregnancy test V. Haemoglobin less than 8g/dl (severe anaemia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of malaria parasitaemia Incidence of clinical malaria | — |
Secondary
| Measure | Time frame |
|---|---|
| Prevalence of parasitemia Prevalence of anaemia Change in haemoglobin Prevalence of PCR-confirmed (LAMP) sub-microscopic parasitaemia Prevalence of gametocytemia Prevalence of artemisinin markers (K13 mutations), partner drug markers in Plasmodium falciparum Number of school days missed Adverse events (safety) | — |
Countries
Uganda
Contacts
Public ContactWinters Muttamba
Project Manager Makerere University Lung Institute
Outcome results
None listed