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

Malaria Clinical Trial

— MalTreSu  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02592408
• Other study ID #: MenziesSHR
• Status: Completed
• Phase: Phase 4
• First received: October 26, 2015
• Last updated: January 31, 2017
• Start date: November 2015
• Est. completion date: May 2016

Study information

• Verified date: January 2017
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months and older

Eligibility

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.

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• ASP
3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
• SDPQ
single dose primaquine on day 2
• 14DPQ
14 day primaquine starting on day 2
• 14DPQ on Day 42
14 day primaquine starting on day 42

Locations

Country	Name	City	State
Sudan	Gizeria Slang Hospital	Khartoum
Sudan	New Halfa Hospital	New Halfa	Kassalla

Sponsors (2)

Lead Sponsor	Collaborator
Menzies School of Health Research	University of Khartoum

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment	Outcome measure is stratified for P. falciparum and P. vivax infections	on days 1,2,3
Secondary	The proportion of patients with fever on day 1, 2 and 3 after treatment	Outcome measure is stratified for P. falciparum and P. vivax infections	on days 1, 2, 3
Secondary	The proportion of patients with gametocytemia on any of the follow up dates	Outcome measure is stratified for P. falciparum and P. vivax infections	In the first 42 days
Secondary	The proportion of patients with severe anaemia (Hb<7g/dl) or requiring blood transfusion within 42 days of enrolment	Outcome measure is stratified for P. falciparum and P. vivax infections	In the first 42 days
Secondary	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	Outcome measure is stratified for P. falciparum and P. vivax infections	on days 0, 7, 14 and 16
Secondary	The proportion of patients with adverse and serious adverse events	Outcome measure is stratified for P. falciparum and P. vivax infections	In the first 42 days
Secondary	The proportion of vivax patients adhering to 14 days of primaquine treatment in the vivax cohort as measured by pill count		at the end of 14DPQ treatment (day 16)
Secondary	The distribution of G6PD activity among the study population		on day of enrolment