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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02592408
• Date of registration: 26/10/2015
• Prospective Registration: Yes
• Primary sponsor: Menzies School of Health Research
• Public title: A Study to Assess Current Standard Malaria Treatment Guidelines in the Republic of the Sudan MalTreSu
• Scientific title: A Study to Assess Current Standard Malaria Treatment Guidelines and Evaluate Recently Developed G6PD Diagnostic Tools in the Republic of the Sudan
• Date of first enrolment: November 2015
• Target sample size: 320
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02592408
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Sudan

Contacts

• Name: Muzamil Mahdi, PhD
• Affiliation: University of Khartoum

Key inclusion & exclusion 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.



Age minimum: 12 Months
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Malaria

Intervention(s)

Drug: 14DPQ

Drug: SDPQ

Drug: ASP

Drug: 14DPQ on Day 42

Primary Outcome(s)

The recurrence of parasitaemia within 42 days of follow in P. falciparum infections [Time Frame: In the first 42 days]

The recurrence of parasitaemia within 42 days of follow in P. vivax infections [Time Frame: In the first 42 days]

Secondary Outcome(s)

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]

The proportion of patients with adverse and serious adverse events [Time Frame: In the first 42 days]

The proportion of patients with fever on day 1, 2 and 3 after treatment [Time Frame: on days 1, 2, 3]

The distribution of G6PD activity among the study population [Time Frame: on day of enrolment]

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]

The proportion of patients with any parasitemia on day 1, 2 and 3 after treatment [Time Frame: on days 1,2,3]

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 proportion of patients with gametocytemia on any of the follow up dates [Time Frame: In the first 42 days]

Secondary ID(s)

MenziesSHR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Khartoum