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Completed

NCT Number: NCT02592408

A Study to Assess Current Standard Malaria Treatment Guidelines 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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

12 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

New Halfa Hospital, New Halfa, Kassalla, Sudan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASP

Drug

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

SDPQ

Drug

single dose primaquine on day 2

14DPQ

Drug

14 day primaquine starting on day 2

14DPQ on Day 42

Drug

14 day primaquine starting on day 42

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. The distribution of G6PD activity among the study population

    Time frame: on day of enrolment

Sponsors and collaborators

Lead sponsor

Menzies School of Health Research

Other

Collaborators

  • University of Khartoum

Registry information

Official study title

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

Acronym: MalTreSu

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 30, 2015
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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