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

NCT ID: NCT02787070

Last Updated: 2019-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 420 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-14
• Study Completion Date: 2018-11-30

Brief 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.

Conditions

Uncomplicated Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Primaquine supervised

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

Group Type: ACTIVE_COMPARATOR

PQ supervised

Intervention Type: DRUG

Primaquine unsupervised

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

Group Type: ACTIVE_COMPARATOR

PQ unsupervised

Intervention Type: DRUG

Interventions

PQ supervised

Intervention Type: DRUG

PQ unsupervised

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia

UNKNOWN

Sponsor Role: collaborator

Menzies School of Health Research

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Timika Research Facility

Timika, Timika-Papua, Indonesia

Countries

Indonesia

References

Poespoprodjo JR, Burdam FH, Candrawati F, Ley B, Meagher N, Kenangalem E, Indrawanti R, Trianty L, Thriemer K, Price DJ, Simpson JA, Price RN. Supervised versus unsupervised primaquine radical cure for the treatment of falciparum and vivax malaria in Papua, Indonesia: a cluster-randomised, controlled, open-label superiority trial. Lancet Infect Dis. 2022 Mar;22(3):367-376. doi: 10.1016/S1473-3099(21)00358-3. Epub 2021 Oct 25.

Reference Type: DERIVED

PMID: 34710363 (View on PubMed)

Other Identifiers

TRIPI

Identifier Type: -

Identifier Source: org_study_id