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

Phase 4

Completed

• Conditions: Malaria
• Interventions: Drug: ASP; Drug: SDPQ; Drug: 14DPQ on Day 42; Drug: 14DPQ

• Registration Number: NCT02592408
• Lead Sponsor: Menzies School of Health Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-26
• Study First Submitted QC: 2015-10-29
• Study First Posted: 2015-10-30
• Study Start: 2015-11
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-31
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pf: ASP + SDPQ	SDPQ	In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2
Pv: ASP + 14DPQ on day 42	14DPQ on Day 42	In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42
Pf: ASP	ASP	In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP)
Pv: ASP + 14DPQ on day 2	ASP	In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2
Pv: ASP + 14DPQ on day 2	14DPQ	In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2
Pf: ASP + SDPQ	ASP	In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2
Pv: ASP + 14DPQ on day 42	ASP	In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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
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 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 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 distribution of G6PD activity among the study population	on day of enrolment
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)

Trial Locations

Locations (2)

New Halfa Hospital; 🇸🇩 New Halfa, Kassalla, Sudan

Gizeria Slang Hospital; 🇸🇩 Khartoum, Sudan