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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02592408
Recruitment Status : Completed
First Posted : October 30, 2015
Last Update Posted : February 1, 2017
Sponsor:
Collaborator:
University of Khartoum
Information provided by (Responsible Party):
Menzies School of Health Research

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.

Condition or disease Intervention/treatment Phase
Malaria Drug: ASP Drug: SDPQ Drug: 14DPQ Drug: 14DPQ on Day 42 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016


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




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   12 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02592408


Locations
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Sudan
New Halfa Hospital
New Halfa, Kassalla, Sudan, 31112
Gizeria Slang Hospital
Khartoum, Sudan, 11111
Sponsors and Collaborators
Menzies School of Health Research
University of Khartoum
Investigators
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Principal Investigator: Muzamil Mahdi, PhD University of Khartoum

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT02592408     History of Changes
Other Study ID Numbers: MenziesSHR
First Posted: October 30, 2015    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Artesunate
Primaquine
Pyrimethamine
Sulfadoxine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents