Malaria
Conditions
Brief summary
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.
Interventions
DRUGASP
3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
DRUGSDPQ
single dose primaquine on day 2
DRUG14DPQ
14 day primaquine starting on day 2
DRUG14DPQ on Day 42
14 day primaquine starting on day 42
Sponsors
University of Khartoum
Menzies School of Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 12 months * P. vivax or P. falciparum mono-infection or P. vivax / P. falciparum mixed infection * Presence of axillary temperature ≥ 37.5°C or history of fever during the past 24 hrs * Able to tolerate oral medication * Able and willing to comply with the study protocol for the duration of the study * Informed consent from the patient or from a parent or guardian in the case of children
Exclusion criteria
* Bodyweight ≤5kg * Presence of general danger signs in children aged under 5 years or signs of severe malaria in any patient according to the definitions of WHO * Presence of severe malnutrition * Acute anaemia \<8g/dL * Regular medication, which may interfere with antimalarial pharmacokinetics * History of hypersensitivity reactions or contraindications to any of the drug(s) tested or used as alternative treatment(s) * A positive pregnancy test or lactating.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The recurrence of parasitaemia within 42 days of follow in P. falciparum infections | In the first 42 days | Outcome measure is presented unadjusted and adjusted for PCR and compared between P. falciparum intervention and control arm |
| The recurrence of parasitaemia within 42 days of follow in P. vivax infections | In the first 42 days | Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of patients with gametocytemia on any of the follow up dates | In the first 42 days | Outcome measure is stratified for P. falciparum and P. vivax infections |
| The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment | In the first 42 days | Outcome measure is stratified for P. falciparum and P. vivax infections |
| 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 | on days 0, 7, 14 and 16 | Outcome measure is stratified for P. falciparum and P. vivax infections |
| The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment | on days 1,2,3 | Outcome measure is stratified for P. falciparum and P. vivax infections |
| The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count | at the end of 14DPQ treatment (day 16) | — |
| The distribution of G6PD activity among the study population | on day of enrolment | — |
| The proportion of patients with adverse and serious adverse events | In the first 42 days | Outcome measure is stratified for P. falciparum and P. vivax infections |
| The proportion of patients with fever on day 1, 2 and 3 after treatment | on days 1, 2, 3 | Outcome measure is stratified for P. falciparum and P. vivax infections |
Countries
Sudan
Outcome results
None listed