A Study to Assess Current Standard Malaria Treatment Guidelines in the Republic of the Sudan

Study Overview
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Brief Summary
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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.

Official Title
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A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan

Conditions
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Malaria

Intervention / Treatment
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* Drug: ASP
* Drug: SDPQ
* Drug: 14DPQ
* Drug: 14DPQ on Day 42


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pf: ASP<br>In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) | Drug: ASP<br>* 3 days of artesunate sulfadoxine/pyrimethamine on days 0-2<br>|
| Active Comparator: Pv: ASP + 14DPQ on day 2<br>In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2 | Drug: ASP<br>* 3 days of artesunate sulfadoxine/pyrimethamine on days 0-2<br>Drug: 14DPQ<br>* 14 day primaquine starting on day 2<br>|
| Active Comparator: Pf: ASP + SDPQ<br>In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2 | Drug: ASP<br>* 3 days of artesunate sulfadoxine/pyrimethamine on days 0-2<br>Drug: SDPQ<br>* single dose primaquine on day 2<br>|
| Active Comparator: Pv: ASP + 14DPQ on day 42<br>In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42 | Drug: ASP<br>* 3 days of artesunate sulfadoxine/pyrimethamine on days 0-2<br>Drug: 14DPQ on Day 42<br>* 14 day primaquine starting on day 42<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | In the first 42 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 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 | 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 | 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 | Outcome measure is stratified for P. falciparum and P. vivax infections | 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 | 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 |  | at the end of 14DPQ treatment (day 16) | 
| The distribution of G6PD activity among the study population |  | on day of enrolment |