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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Randomized Trial of Two Antimalarial Treatments for Clearing Low Density P.Falciparum Parasitaemia in Sudan

NCT00330902

Plasmodium Infections

COMPLETED PHASE3

Antimalarial Treatments for Clearing Low Density P. Falciparum and Its Impact on Malaria Transmission

NCT00646126

Plasmodium Falciparum Asymptomatic Parataemia Sub Patent Parasitaemia

COMPLETED PHASE3

A Study to Assess Safety of Current Standard Malaria Treatment and an Assessment of G6PD Status in South-east Bangladesh

NCT02389374

Malaria

COMPLETED PHASE4

A Trial of Four Drug Regimens for the Prevention of Malaria in Senegalese Children

NCT00132548

Malaria

COMPLETED PHASE3

A Randomised Efficacy Study of Combination Antimalarials to Treat Uncomplicated Malaria

NCT00203814

Malaria

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pv: ASP + 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

Group Type ACTIVE_COMPARATOR

ASP

Intervention Type DRUG

3 days of artesunate sulfadoxine/pyrimethamine on days 0-2

14DPQ on Day 42

Intervention Type DRUG

14 day primaquine starting on day 42

Pf: ASP

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

Group Type ACTIVE_COMPARATOR

ASP

Intervention Type DRUG

3 days of artesunate sulfadoxine/pyrimethamine on days 0-2

Pv: ASP + 14DPQ on day 2

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

Group Type ACTIVE_COMPARATOR

ASP

Intervention Type DRUG

3 days of artesunate sulfadoxine/pyrimethamine on days 0-2

14DPQ

Intervention Type DRUG

14 day primaquine starting on day 2

Pf: ASP + SDPQ

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

Group Type ACTIVE_COMPARATOR

ASP

Intervention Type DRUG

3 days of artesunate sulfadoxine/pyrimethamine on days 0-2

SDPQ

Intervention Type DRUG

single dose primaquine on day 2

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ASP

3 days of artesunate sulfadoxine/pyrimethamine on days 0-2

Intervention Type DRUG

SDPQ

single dose primaquine on day 2

Intervention Type DRUG

14DPQ

14 day primaquine starting on day 2

Intervention Type DRUG

14DPQ on Day 42

14 day primaquine starting on day 42

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

12 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No