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

Menzies School of Health Research

Status and phase: Completed; Phase 4

Conditions: Uncomplicated Malaria

Treatments: Drug: PQ supervised; Drug: PQ unsupervised

Study type: Interventional

Funder types: Other

Identifiers

NCT02787070

TRIPI

Details and patient eligibility

About

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.

Enrollment: 420 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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 β-HCG pregnancy test
• Known hypersensitivity to any of the drugs given

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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420 participants in 2 patient groups

Primaquine supervised

Active Comparator group

Description:

14 days of supervised primaquine treatment (0.5mg/kg/day).

Treatment:

Drug: PQ supervised

Primaquine unsupervised

Active Comparator group

Description:

14 days of unsupervised primaquine treatment (0.5mg/kg/day).

Treatment:

Drug: PQ unsupervised