Uncomplicated falciparum Malaria, G6PD deficiency, Single low dose primaquine (SLDPQ) Infections and Infestations Uncomplicated falciparum Malaria, G6PD deficiency, Single low dose primaquine (SLDPQ)
Conditions
Interventions
Participants are allocated to either the G6PDd group or the G6PD normal group based on their the results of a G6PD rapid diagnostic test (RDT).
Participants are then randomly allocated as to which do
Sponsors
The University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 6 months to 11 years old 2. Clinically uncomplicated disease 3. Fever (=37.5°C aural) or history of fever within the previous 72 hours 4. Positive malaria RDT (Uganda only) 5. Positive malaria slide for P. falciparum (mono or mixed infection) of any parasitaemia (Kinshasa only) 6. Informed consent provided by patient or relative/legal guardian
Exclusion criteria
Exclusion criteria: 1. Malaria danger signs, sign(s) of severe malaria, or decompensated anaemia, including: an inability to take or retain fluids or oral medications, confusion, prostration, convulsions, respiratory distress, passing of red or cola-coloured urine (putative “blackwater fever”) 2. Severe anaemia (Hb <6 g/dL) 3. Comorbid illness that requires treatment in hospital (physician’s judgement) 4. Patients on drugs known to cause haemolysis in G6PDd e.g. dapsone, nalidixic acid 5. Known to be allergic to PQ, AL, or DHAPP 6. Previous enrolment in the current trial or current enrolment in another trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Profound anaemia (Hb concentration < 4g/dL) is measured using the HemoCue machine during the first days 21 days of follow up 2. Severe anaemia (Hb <5g/dL) with clinical features of severe malaria is measured using the HemoCue machine during the first 21 days of follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fractional change in haemoglobin on day seven vs. baseline, measured by HemoCue® at baseline and day seven 2. Proportion of patients with a fractional change of = 25% measured by HemoCue® over the follow up period of 42 days 3. Determinants of changes in HemoCue® measured haemoglobin over the follow up period of 42 days 4. G6PD genotype (hemizygous male, homo-, heterozygous female, normal) and selected G6PD variants (e.g. G6PD A- 202 mutations) are assessed by polymerase chain reaction (PCR) at baseline 5. G6PD enzyme activity is measured using a quantitative spectrophotometric method at baseline 6. Genotypes of other inherited blood disorders are assessed by polymerase chain reaction (PCR) at baseline 7. Incidence of adverse events are measured using clinical and laboratory records over the follow up period of 42 days 8. Pharmacokinetic characteristics of PQ and carboxyPQ by measuring drug concentrations at baseline and at hours one, one and a half, two, three, four, six, eight, ten, 12, 24 hours 9. Pharmacokinetic characteristics of lumefantrine and piperaquine are measured using their drug concentrations at baseline, day three, seven and 28 10. CYP 2D6 genotypes are assessed by polymerase chain reaction (PCR) at baseline 11. Asexual parasitaemia clearance time and half life are measured using malaria slide results at days one, two and three 12. Therapeutic efficacy of AL and DHAPP is measured using the WHO criteria at day 42 13. Gametocytaemia over time is measured using thick blood films at baseline and days one, two, three, seven, 14, 21, 28, 35 and 42 14. Proportion of patients with gametocytes over time is measured using those with a positive thick blood film at baseline and on days one, two, three, seven, 14, 21, 28, 35 and 42 | — |
Countries
Congo, Democratic Republic, Uganda
Contacts
Public ContactBob Taylor
Outcome results
None listed