This is a randomized controlled trial to assess the efficacy and safety of the national malaria treatment guidelines, asses the efficacy and safety of artesunate and sulphadoxine - pyrimethamine (AS+SP) for treatment in uncomplicated P. falciparum and P. vivax malaria and the hematologic effect of 14 days routine primaquine based radical cure in patients suffering from a P. vivax or mixed infection.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
320
New Halfa Hospital
New Halfa, Kassalla, Sudan
Gizeria Slang Hospital
Khartoum, Khartoum State, Sudan
The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. falciparum intervention and control arm
Time frame: In the first 42 days
The recurrence of parasitaemia within 42 days of follow in P. vivax infections
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm
Time frame: In the first 42 days
The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment
Outcome measure is stratified for P. falciparum and P. vivax infections
Time frame: on days 1,2,3
The proportion of patients with fever on day 1, 2 and 3 after treatment
Outcome measure is stratified for P. falciparum and P. vivax infections
Time frame: on days 1, 2, 3
The proportion of patients with gametocytemia on any of the follow up dates
Outcome measure is stratified for P. falciparum and P. vivax infections
Time frame: In the first 42 days
The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment
Outcome measure is stratified for P. falciparum and P. vivax infections
Time frame: In the first 42 days
The fractional change in Hb between baseline and day 7,14 and 16 (incl. proportion of patients with >25% drop in Hb between the time points) in vivax / mixed infection patients receiving PQ
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14 day primaquine starting on day 42
Outcome measure is stratified for P. falciparum and P. vivax infections
Time frame: on days 0, 7, 14 and 16
The proportion of patients with adverse and serious adverse events
Outcome measure is stratified for P. falciparum and P. vivax infections
Time frame: In the first 42 days
The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count
Time frame: at the end of 14DPQ treatment (day 16)
The distribution of G6PD activity among the study population
Time frame: on day of enrolment