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

NCT02592408 | Completed Phase 4

• 1 other identifier: MenziesSHR
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (2)

• 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

  In the first 42 days

• 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

  In the first 42 days

Secondary Outcomes (8)

• The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment

  on days 1,2,3

• The proportion of patients with fever on day 1, 2 and 3 after treatment

  on days 1, 2, 3

• The proportion of patients with gametocytemia on any of the follow up dates

  In the first 42 days

• The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment

  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

  on days 0, 7, 14 and 16

Study Arms (4)

Pf: ASP

ACTIVE COMPARATOR

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

Drug: ASP

Pv: ASP + 14DPQ on day 2

ACTIVE COMPARATOR

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

Drug: ASP; Drug: 14DPQ

Pf: ASP + SDPQ

ACTIVE COMPARATOR

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

Drug: ASP; Drug: SDPQ

Pv: ASP + 14DPQ on day 42

ACTIVE COMPARATOR

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

Drug: ASP; Drug: 14DPQ on Day 42

Interventions

ASP DRUG

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

Pf: ASP; Pf: ASP + SDPQ; Pv: ASP + 14DPQ on day 2; Pv: ASP + 14DPQ on day 42

SDPQ DRUG

single dose primaquine on day 2

Pf: ASP + SDPQ

14DPQ DRUG

14 day primaquine starting on day 2

Pv: ASP + 14DPQ on day 2

14DPQ on Day 42 DRUG

14 day primaquine starting on day 42

Pv: ASP + 14DPQ on day 42

Eligibility Criteria

• Age: 12 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Menzies School of Health Research: lead
• University of Khartoum: collaborator

Study Sites (2)

New Halfa Hospital

New Halfa, Kassalla, 31112, Sudan

Location

Gizeria Slang Hospital

Khartoum, Khartoum State, 11111, Sudan

Location

Related Publications (1)

• 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.

  PMID: 29548285 DERIVED

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

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

Study Officials

• Muzamil Mahdi, PhD

  University of Khartoum

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2015
• First Posted: October 30, 2015
• Study Start: November 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: February 1, 2017

Record last verified: 2017-01

Locations

SU (2)