NCT02787070

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 14, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

April 16, 2019

Status Verified

April 1, 2019

Enrollment Period

2.1 years

First QC Date

May 26, 2016

Last Update Submit

April 12, 2019

Conditions

Uncomplicated Malaria

Outcome Measures

Primary Outcomes (1)

  • The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with any malaria infection

    6 months

Secondary Outcomes (12)

  • The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria infection

    6 months

  • The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria infection

    6 months

  • 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

  • The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria

    6 months

  • The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria

    6 months

  • +7 more secondary outcomes

Study Arms (2)

Primaquine supervised

ACTIVE COMPARATOR

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

Drug: PQ supervised

Primaquine unsupervised

ACTIVE COMPARATOR

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

Drug: PQ unsupervised

Interventions

PQ supervisedDRUG
Primaquine supervised
PQ unsupervisedDRUG
Primaquine unsupervised

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Infection with Plasmodium falciparum or P. vivax either alone or mixed
  • Age \>12 months
  • Weight \>5kg
  • Living in the study clusters

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Timika Research Facility

Timika, Timika-Papua, Indonesia

Location

Related Publications (1)

  • 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.

    PMID: 34710363DERIVED

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 1, 2016

Study Start

September 14, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

April 16, 2019

Record last verified: 2019-04

Locations

ID(1)