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

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ClinicalTrials.gov Identifier: NCT02787070
Recruitment Status : Completed
First Posted : June 1, 2016
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
Information provided by (Responsible Party):
Menzies School of Health Research

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.


Condition or disease Intervention/treatment Phase
Uncomplicated Malaria Drug: PQ supervised Drug: PQ unsupervised Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial on Malaria Primaquine Treatment in Timika, Indonesia (TRIPI)
Actual Study Start Date : September 14, 2016
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Primaquine supervised
14 days of supervised primaquine treatment (0.5mg/kg/day).
Drug: PQ supervised
Active Comparator: Primaquine unsupervised
14 days of unsupervised primaquine treatment (0.5mg/kg/day).
Drug: PQ unsupervised



Primary Outcome Measures :
  1. The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with any malaria infection [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria infection [ Time Frame: 6 months ]
  2. The incidence risk of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria infection [ Time Frame: 6 months ]
  3. The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with malaria due to P. falciparum or P. vivax [ Time Frame: 6 months ]
  4. The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. vivax malaria [ Time Frame: 6 months ]
  5. The incidence rate of symptomatic P. vivax malaria over 6 months in patients enrolled with P. falciparum malaria [ Time Frame: 6 months ]
  6. 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) [ Time Frame: 6 months ]
  7. The incidence risk of any patent or sub-microscopic parasitaemia due to P. vivax or P. falciparum over six months in patients [ Time Frame: 6 months ]
  8. The proportion of patients vomiting their medication within 1 hour of administration [ Time Frame: 1 hour ]
  9. • The proportion of patients vomiting any of their primaquine doses during the 14 day supervised course [ Time Frame: 14 days ]
  10. • The proportion of adverse events and serious adverse events over 6 months in all patients [ Time Frame: 6 months ]
  11. • The incidence risk of severe anaemia (Hb<7g/dl) and/or the risk for blood transfusion over 6 months [ Time Frame: 6 months ]
  12. • The incidence risk of an acute drop in Hb >5g/dl within 14 days of starting primaquine treatment [ Time Frame: 14 days ]


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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02787070


Locations
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Indonesia
Timika Research Facility
Timika, Timika-Papua, Indonesia
Sponsors and Collaborators
Menzies School of Health Research
Timika Research Facility Kompleks RSMM, Timika-Papua, Indonesia
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Responsible Party: Menzies School of Health Research
ClinicalTrials.gov Identifier: NCT02787070    
Other Study ID Numbers: TRIPI
First Posted: June 1, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases