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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

Tracking Information
First Submitted Date  ICMJE October 26, 2015
First Posted Date  ICMJE October 30, 2015
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE November 2015
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • The recurrence of parasitaemia within 42 days of follow in P. falciparum infections [ Time Frame: 10 months ]
    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 [ Time Frame: 10 months ]
    Outcome measure is presented unadjusted and adjusted for PCR and compared between P. vivax intervention and control arm
Change History Complete list of historical versions of study NCT02592408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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) ]
  • The distribution of G6PD activity among the study population [ Time Frame: on day of enrolment ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2015)
  • The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment [ Time Frame: 10 months ]
    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 [ Time Frame: 10 months ]
    Outcome measure is stratified for P. falciparum and P. vivax infections
  • The proportion of patients with gametocytemia on any of the follow up dates [ Time Frame: 10 months ]
    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 [ Time Frame: 10 months ]
    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 [ Time Frame: 10 months ]
    Outcome measure is stratified for P. falciparum and P. vivax infections
  • The proportion of patients with adverse and serious adverse events [ Time Frame: 10 months ]
    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 [ Time Frame: 10 months ]
  • The distribution of G6PD activity among the study population [ Time Frame: 10 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Assess Current Standard Malaria Treatment Guidelines in the Republic of the Sudan
Official Title  ICMJE A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Malaria
Intervention  ICMJE
  • Drug: ASP
    3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
  • Drug: SDPQ
    single dose primaquine on day 2
  • Drug: 14DPQ
    14 day primaquine starting on day 2
  • Drug: 14DPQ on Day 42
    14 day primaquine starting on day 42
Study Arms  ICMJE
  • Active Comparator: Pf: ASP
    In falciparum patients (Pf): 3 days of artesunate + sulfadoxine/pyrimethamine (ASP)
    Intervention: Drug: ASP
  • 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
    Interventions:
    • Drug: ASP
    • Drug: 14DPQ
  • 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
    Interventions:
    • Drug: ASP
    • Drug: SDPQ
  • 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
    Interventions:
    • Drug: ASP
    • Drug: 14DPQ on Day 42
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 31, 2017)
320
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2015)
280
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sudan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02592408
Other Study ID Numbers  ICMJE MenziesSHR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Menzies School of Health Research
Study Sponsor  ICMJE Menzies School of Health Research
Collaborators  ICMJE University of Khartoum
Investigators  ICMJE
Principal Investigator: Muzamil Mahdi, PhD University of Khartoum
PRS Account Menzies School of Health Research
Verification Date January 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP