search
Back to results

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

Primary Purpose

Malaria

Status
Completed
Phase
Phase 4
Locations
Sudan
Study Type
Interventional
Intervention
ASP
SDPQ
14DPQ
14DPQ on Day 42
Sponsored by
Menzies School of Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malaria

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • New Halfa Hospital
  • Gizeria Slang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Pf: ASP

Pv: ASP + 14DPQ on day 2

Pf: ASP + SDPQ

Pv: ASP + 14DPQ on day 42

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
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
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm

Secondary Outcome Measures

The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment
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
Outcome measure is stratified for P. falciparum and P. vivax infections
The proportion of patients with gametocytemia on any of the follow up dates
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
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
Outcome measure is stratified for P. falciparum and P. vivax infections
The proportion of patients with adverse and serious adverse events
Outcome measure is stratified for P. falciparum and P. vivax infections
The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count
The distribution of G6PD activity among the study population

Full Information

First Posted
October 26, 2015
Last Updated
January 31, 2017
Sponsor
Menzies School of Health Research
Collaborators
University of Khartoum
search

1. Study Identification

Unique Protocol Identification Number
NCT02592408
Brief Title
A Study to Assess Current Standard Malaria Treatment Guidelines in the Republic of the Sudan
Acronym
MalTreSu
Official Title
A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menzies School of Health Research
Collaborators
University of Khartoum

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
320 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pf: ASP
Arm Type
Active Comparator
Arm Description
In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP)
Arm Title
Pv: ASP + 14DPQ on day 2
Arm Type
Active Comparator
Arm Description
In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 2
Arm Title
Pf: ASP + SDPQ
Arm Type
Active Comparator
Arm Description
In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and a single dose of primaquine (SDPQ) on day 2
Arm Title
Pv: ASP + 14DPQ on day 42
Arm Type
Active Comparator
Arm Description
In vivax patients (Pv): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP) and 14 days of primaquine (14DPQ) starting on day 42
Intervention Type
Drug
Intervention Name(s)
ASP
Intervention Description
3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
Intervention Type
Drug
Intervention Name(s)
SDPQ
Intervention Description
single dose primaquine on day 2
Intervention Type
Drug
Intervention Name(s)
14DPQ
Intervention Description
14 day primaquine starting on day 2
Intervention Type
Drug
Intervention Name(s)
14DPQ on Day 42
Intervention Description
14 day primaquine starting on day 42
Primary Outcome Measure Information:
Title
The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
Description
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. falciparum intervention and control arm
Time Frame
In the first 42 days
Title
The recurrence of parasitaemia within 42 days of follow in P. vivax infections
Description
Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm
Time Frame
In the first 42 days
Secondary Outcome Measure Information:
Title
The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment
Description
Outcome measure is stratified for P. falciparum and P. vivax infections
Time Frame
on days 1,2,3
Title
The proportion of patients with fever on day 1, 2 and 3 after treatment
Description
Outcome measure is stratified for P. falciparum and P. vivax infections
Time Frame
on days 1, 2, 3
Title
The proportion of patients with gametocytemia on any of the follow up dates
Description
Outcome measure is stratified for P. falciparum and P. vivax infections
Time Frame
In the first 42 days
Title
The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment
Description
Outcome measure is stratified for P. falciparum and P. vivax infections
Time Frame
In the first 42 days
Title
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
Description
Outcome measure is stratified for P. falciparum and P. vivax infections
Time Frame
on days 0, 7, 14 and 16
Title
The proportion of patients with adverse and serious adverse events
Description
Outcome measure is stratified for P. falciparum and P. vivax infections
Time Frame
In the first 42 days
Title
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)
Title
The distribution of G6PD activity among the study population
Time Frame
on day of enrolment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Muzamil Mahdi, PhD
Organizational Affiliation
University of Khartoum
Official's Role
Principal Investigator
Facility Information:
Facility Name
New Halfa Hospital
City
New Halfa
State/Province
Kassalla
ZIP/Postal Code
31112
Country
Sudan
Facility Name
Gizeria Slang Hospital
City
Khartoum
ZIP/Postal Code
11111
Country
Sudan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29548285
Citation
Hamid MMA, Thriemer K, Elobied ME, Mahgoub NS, Boshara SA, Elsafi HMH, Gumaa SA, Hamid T, Abdelbagi H, Basheir HM, Marfurt J, Chen I, Gosling R, Price RN, Ley B. Low risk of recurrence following artesunate-Sulphadoxine-pyrimethamine plus primaquine for uncomplicated Plasmodium falciparum and Plasmodium vivax infections in the Republic of the Sudan. Malar J. 2018 Mar 16;17(1):117. doi: 10.1186/s12936-018-2266-9.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs