A Trial on Supervised Primaquine Use in Ethiopia

NCT02793388 | Withdrawn Phase 4

• 1 other identifier: HREC 2016-2620
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria.

  4 months

Secondary Outcomes (9)

• The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria infection.

  4 months

• The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria infection.

  4 months

• The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with malaria due to P. falciparum or P. vivax.

  4 months

• The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria.

  4 months

• The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria.

  4 months

Other Outcomes (5)

• The proportion of patients vomiting their medication within 1 hour of administration.

  1 day

• The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course.

  1 day

• The proportion of adverse events and serious adverse events over 4 months in all patients.

  1 year

Study Arms (2)

Supervised primaquine arm

ACTIVE COMPARATOR

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.

Drug: Supervised primaquine treatment

Unsupervised primaquine arm

ACTIVE COMPARATOR

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.

Drug: Unsupervised primaquine treatment

Interventions

Supervised primaquine treatment DRUG

Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided supervised every other day.

Supervised primaquine arm

Unsupervised primaquine treatment DRUG

Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided unsupervised.

Unsupervised primaquine arm

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Menzies School of Health Research: lead
• Armauer Hansen Research Institute, Ethiopia: collaborator

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 8, 2016
• Study Start: September 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: February 8, 2017

Record last verified: 2017-02