A Randomized Controlled Trial on Malaria Primaquine Treatment in Timika, Indonesia (TRIPI)

Uncomplicated Malaria Clinical Trial

— TRIPI  

Official title:

A Randomized Controlled Trial on Malaria Primaquine Treatment in Timika, Indonesia (TRIPI)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02787070
• Other study ID #: TRIPI
• Status: Completed
• Phase: Phase 4
• Start date: September 14, 2016
• Est. completion date: November 2018

Study information

• Verified date: April 2019
• Source: Menzies School of Health Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Plasmodium vivax can form dormant liver stages that reactivate weeks or months following an acute infection. Recurrent infections can be associated with a febrile illness, a cumulative risk of severe anaemia, and even mortality. In co-endemic areas the risk of recurrence after both P. vivax and P. falciparum infections can be over 50% within 3 months. The only drug we have to kill P. vivax hypnozoites is primaquine which is currently given as a 14 day regimen. In Papua a retrospective study found very low effectiveness for unsupervised treatment. If true this has profound effects on treatment policy, suggesting that greater efforts are needed to encourage adherence to treatment.

We propose a cluster randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. Since the risk of recurrent P. vivax is high in patients with either P. vivax or P. falciparum, both infections will be included in the study. The study will be conducted in Mimika, in the southern part of Papua Province, Indonesia. Participants will be enrolled at village health posts and provided with schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised depending on which cluster the clinic is in. Participants will be followed up for 6 months and assessed in 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: Completed
• Enrollment: 420
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

Eligibility

Inclusion Criteria:

• Infection with Plasmodium falciparum or P. vivax either alone or mixed

• Age >12 months

• Weight >5kg

• Living in the study clusters

Exclusion Criteria:

• General danger signs or symptoms of severe malaria

• Anaemia, defined as Hb <9g/dl

• G6PD deficiency (as determined by FST)

• Pregnant women as determined by Urine ß-HCG pregnancy test

• Known hypersensitivity to any of the drugs given

Related Conditions & MeSH terms

• Malaria
• Uncomplicated Malaria

Intervention

Drug:
• PQ supervised

• PQ unsupervised

Locations

Country	Name	City	State
Indonesia	Timika Research Facility	Timika	Timika-Papua

Sponsors (2)

Lead Sponsor	Collaborator
Menzies School of Health Research	Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with any malaria infection		6 months
Secondary	The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria infection		6 months
Secondary	The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria infection		6 months
Secondary	The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with malaria due to P. falciparum or P. vivax		6 months
Secondary	The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria		6 months
Secondary	The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria		6 months
Secondary	The incidence risk of patent or sub-microscopic P. vivax malaria over six months in patients enrolled with a malaria (sub-group analysis for patients recruited with P. vivax infection and P. falciparum infection)		6 months
Secondary	The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over six months in patients		6 months
Secondary	The proportion of patients vomiting their medication within 1 hour of administration		1 hour
Secondary	• The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course		14 days
Secondary	• The proportion of adverse events and serious adverse events over 6 months in all patients		6 months
Secondary	• The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion over 6 months		6 months
Secondary	• The incidence risk of an acute drop in Hb >5g/dl within 14 days of starting primaquine treatment		14 days