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

• Sponsor: Menzies School of Health Research (Other)
• Overall Status: Completed
• CT.gov ID: NCT02592408
• Collaborator: University of Khartoum (Other)
• Enrollment: 320
• Locations: 2
• Arms: 4
• Duration (Months): 6
• Patients Per Site: 160
• Patients Per Site Per Month: 26.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• 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: Nov 1, 2015
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. The recurrence of parasitaemia within 42 days of follow in P. falciparum infections [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 [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 [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 [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 [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 [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 [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 [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 [at the end of 14DPQ treatment (day 16)]

8. The distribution of G6PD activity among the study population [on day of enrolment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Months and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Age ≥ 12 months

• 1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New Halfa Hospital	New Halfa	Kassalla	Sudan	31112
2	Gizeria Slang Hospital	Khartoum		Sudan	11111

Sponsors and Collaborators

• Menzies School of Health Research
• University of Khartoum

Investigators

• Principal Investigator: Muzamil Mahdi, PhD, University of Khartoum

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Menzies School of Health Research
• ClinicalTrials.gov Identifier: NCT02592408
• Other Study ID Numbers: MenziesSHR
• First Posted: Oct 30, 2015
• Last Update Posted: Feb 1, 2017
• Last Verified: Jan 1, 2017

• Additional relevant MeSH terms: Malaria

Study Results

No Results Posted as of Feb 1, 2017