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

January 31, 2017 updated by: Menzies School of Health Research

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
      • Khartoum, Sudan, 11111
        • Gizeria Slang Hospital
    • Kassalla
      • New Halfa, Kassalla, Sudan, 31112
        • New Halfa Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
Time Frame: In the first 42 days
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
Time Frame: In the first 42 days
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
Time Frame: on days 1,2,3
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
Time Frame: on days 1, 2, 3
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
Time Frame: In the first 42 days
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
Time Frame: In the first 42 days
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
Time Frame: on days 0, 7, 14 and 16
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
Time Frame: In the first 42 days
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
Time Frame: at the end of 14DPQ treatment (day 16)
at the end of 14DPQ treatment (day 16)
The distribution of G6PD activity among the study population
Time Frame: on day of enrolment
on day of enrolment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menzies School of Health Research

Collaborators

University of Khartoum

Investigators

  • Principal Investigator: Muzamil Mahdi, PhD, University of Khartoum

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

October 26, 2015

First Submitted That Met QC Criteria

October 29, 2015

First Posted (Estimate)

October 30, 2015

Study Record Updates

Last Update Posted (Estimate)

February 1, 2017

Last Update Submitted That Met QC Criteria

January 31, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MenziesSHR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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