Clinical trial NCT02592408: A Study to Assess Current Standard Malaria Treatment Guidelines in the Republic of the Sudan
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: University of Khartoum
First posted: 2015-10-30
Enrollment: 320
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The recurrence of parasitaemia within 42 days of follow in P. falciparum infections
timeFrame: In the first 42 days
measure: The recurrence of parasitaemia within 42 days of follow in P. vivax infections
timeFrame: In the first 42 days
Secondary outcomes:
measure: The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment
timeFrame: on days 1,2,3
measure: The proportion of patients with fever on day 1, 2 and 3 after treatment
timeFrame: on days 1, 2, 3
measure: The proportion of patients with gametocytemia on any of the follow up dates
timeFrame: In the first 42 days
measure: The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment
timeFrame: In the first 42 days
measure: 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
timeFrame: on days 0, 7, 14 and 16
measure: The proportion of patients with adverse and serious adverse events
timeFrame: In the first 42 days
measure: The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count
timeFrame: at the end of 14DPQ treatment (day 16)
measure: The distribution of G6PD activity among the study population
timeFrame: on day of enrolment
Other outcomes:
Locations:
city: New Halfa
country: Sudan
facility: New Halfa Hospital
state: Kassalla
city: Khartoum
country: Sudan
facility: Gizeria Slang Hospital
Study officials:
affiliation: University of Khartoum
name: Muzamil Mahdi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.