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

Menzies School of Health Research

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Drug: 14DPQ on Day 42; Drug: 14DPQ; Drug: SDPQ; Drug: ASP

Study type: Interventional

Funder types: Other

Identifiers

NCT02592408

MenziesSHR

Details and patient eligibility

About

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.

Enrollment: 320 patients

Sex: All

Ages: 12+ months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 4 patient groups

Pf: ASP

Active Comparator group

Description:

In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP)

Treatment:

Drug: ASP

Pv: ASP + 14DPQ on day 2

Active Comparator group

Description:

In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2

Treatment:

Drug: 14DPQ

Drug: ASP

Pf: ASP + SDPQ

Active Comparator group

Description:

In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2

Treatment:

Drug: SDPQ

Drug: ASP

Pv: ASP + 14DPQ on day 42

Active Comparator group

Description:

In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42

Treatment:

Drug: 14DPQ on Day 42

Drug: ASP