Overview

This trial is active, not recruiting.

Condition malaria
Treatments asp, sdpq, 14dpq, 14dpq on day 42
Phase phase 4
Sponsor Menzies School of Health Research
Collaborator University of Khartoum
Start date November 2015
End date August 2016
Trial size 280 participants
Trial identifier NCT02592408, MenziesSHR

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP)
asp
3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
(Active Comparator)
In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2
asp
3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
14dpq
14 day primaquine starting on day 2
(Active Comparator)
In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2
asp
3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
sdpq
single dose primaquine on day 2
(Active Comparator)
In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42
asp
3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
14dpq on day 42
14 day primaquine starting on day 42

Primary Outcomes

Measure
The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
time frame: In the first 42 days
The recurrence of parasitaemia within 42 days of follow in P. vivax infections
time frame: In the first 42 days

Secondary Outcomes

Measure
The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment
time frame: on days 1,2,3
The proportion of patients with fever on day 1, 2 and 3 after treatment
time frame: on days 1, 2, 3
The proportion of patients with gametocytemia on any of the follow up dates
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
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
time frame: on days 0, 7, 14 and 16
The proportion of patients with adverse and serious adverse events
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

Eligibility Criteria

Male or female participants at least 12 months old.

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.

Additional Information

Official title A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan
Principal investigator Muzamil Mahdi, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Menzies School of Health Research.