A Trial on Supervised Primaquine Use in Ethiopia (SPRUE)

Menzies School of Health Research

Status and phase: Withdrawn; Phase 4

Conditions: Malaria

Treatments: Drug: Unsupervised primaquine treatment; Drug: Supervised primaquine treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT02793388

HREC 2016-2620

Details and patient eligibility

About

This is a randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is high. Hence patients infected with either P. vivax or P. falciparum will be included in the study. The study will be conducted in Ethiopia. Participants will be enrolled at health centres and provided with the recommended schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised according to randomisation. Participants will be followed up for four months and assessed at regular intervals for the presence of patent and sub-patent malaria. The outcome of the study will contribute to an improved treatment scheme for uncomplicated malaria in this area.

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
• Age >5 years
• Weight >5kg
• Written informed consent
• Living in the study area and willing to be followed for 4 months

Exclusion criteria

• General danger signs or symptoms of severe malaria (Appendix 17.1 and 17.2)
• Anaemia, defined as Hb <8g/dl
• Pregnant women as determined by Urine β-HCG pregnancy test
• Breast feeding women
• Known hypersensitivity to any of the drugs given
• Living in the same household as an individual enrolled into the study in the last 14 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Supervised primaquine arm

Active Comparator group

Description:

Following standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure. Supervision of primaquine is done on alternate days at home (attended by a home visitor) or at the health centre.

Treatment:

Drug: Supervised primaquine treatment

Unsupervised primaquine arm

Active Comparator group

Description:

Following standard schizontocidal treatment according to national guidelines and if haemoglobin levels are above 8g/dL and G6PD testing is normal, the patient receives primaquine (0.5mg/kg/day) for 14 days for radical cure for self administration.

Treatment:

Drug: Unsupervised primaquine treatment