Malaria
Conditions
Interventions
Single Low Dose Primaquine
Routine Artemisinin Based Combination Treatment
Sponsors
ReMeD Reseau Medicaments et Developpement
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients responding to the following criteria will be included: • age = 6 months • presentation with clinically uncomplicated disease and a fever/history of fever and either a positive rapid diagnostic rapid test for falciparum malaria, and • consent and assent for children aged 12-17 years • Resident in the study area
Exclusion criteria
Exclusion criteria: Any patient presenting one of the following criteria will be excluded: • Anaemia (Hb concentration): Hb <6 g/dL (age <12y) or <7 g/dL (= 12y) • Malaria danger signs, sign(s) of severe malaria, or decompensated anaemia, including: o An inability to take or retain fluids or oral medications o confusion o prostration o convulsions o respiratory distress • passing of red or cola-coloured urine (putative “blackwater fever”) • a comorbid illness that requires treatment in hospital or referral to a higher-level clinic (clinical judgement) • patients with significant/complex medical illnesses e.g., HIV, TB, leprosy • patients on drugs known to cause haemolysis in G6PDd e.g., dapsone, nalidixic acid • Known to be allergic to PQ and to all ACTs • Known to be pregnant or think they are very likely to be pregnant by history (e.g. amenorrhoea in a woman of child bearing age or positive pregnant test)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • all children aged <12y who develop a Hb concentration of <6 g/dL, irrespective of their clinical state, and • all other patients who develop a Hb <7 g/dL, irrespective of their clinical state, following treatment for acute uncomplicated falciparum malaria. | — |
Secondary
| Measure | Time frame |
|---|---|
| occurrence of gastrointestinal symptoms: e.g., abdominal pain, nausea, early vomiting. • haemoglobin concentration on Day 3 (D3) • thick blood film positive for asexual parasites on D3 & detection of K13 mutation • sexual parasites carriage rates on D3 (optional ‘and D7 in a subset’*) • % of isolates with molecular markers of drug resistance • % of carriers of HRP2/3 mutant parasites • acceptability score of the new formulation in the target population: children under 12 years of age. | — |
Countries
Burkina Faso, Burundi, Madagascar
Contacts
Public ContactPascal Millet
Director
Outcome results
None listed