A Trial on Supervised Primaquine Use in Ethiopia

Malaria Clinical Trial

— SPRUE  

Official title:

A Randomized Controlled Trial on Supervised Primaquine Use in Ethiopia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02793388
• Other study ID #: HREC 2016-2620
• Status: Withdrawn
• Phase: Phase 4
• First received: May 26, 2016
• Last updated: February 7, 2017
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: February 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, 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Fever (axillary temperature =37.5°C) 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 ß-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

Related Conditions & MeSH terms

• Malaria

Intervention

Drug:
• Supervised primaquine treatment
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.
• Unsupervised primaquine treatment
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Menzies School of Health Research	Armauer Hansen Research Institute, Ethiopia

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The proportion of patients vomiting their medication within 1 hour of administration.		1 day
Other	The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course.		1 day
Other	The proportion of adverse events and serious adverse events over 4 months in all patients.		1 year
Other	The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion over 4 months.		4 months
Other	The incidence risk of an acute drop in Hb >5g/dl within 14 days of starting primaquine treatment.		14 days
Primary	The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax or P. falciparum malaria.		4 months
Secondary	The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria infection.		4 months
Secondary	The incidence risk of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria infection.		4 months
Secondary	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
Secondary	The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. vivax malaria.		4 months
Secondary	The incidence rate of symptomatic P. vivax malaria over 4 months in patients enrolled with P. falciparum malaria.		4 months
Secondary	The incidence risk of patent or sub-microscopic P. vivax malaria over 4 months in patients enrolled with malaria (sub-group analysis for patients recruited with P. vivax infection and P. falciparum infection)		4 months
Secondary	The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over 4 months in patients		4 months
Secondary	The cost-effectiveness of supervised primaquine therapy in terms of cost per malaria episode averted		1 year
Secondary	Socio-economic factors for adherence to primaquine treatment	Factors are collected through a semi-standardized questionaire. Factors include indicators for economic status, as well as information on educational background.	1 year