NCT01288820

Brief Summary

This randomized clinical trial will be conducted in subjects with uncomplicated Plasmodium vivax malaria during November 2010 to March 2012. The aim of the study is to compare the efficacy and safety of artesunate-amodiaquine plus primaquine (AS-AQ + PQ) and dihydroartemisinin-piperaquine plus primaquine (DHP + PQ) in uncomplicated vivax malaria. The significance of the study is to find alternative drug for treating patients with vivax malaria in case the standard treatment is not available or become resistance. This study will give thorough information about the efficacy and safety of 2 artemisinin-based combination therapies (ACTs) in combination with primaquine. It will also inform the Indonesian Ministry of Health on their suggested policies for radical cure of vivax malaria, and provides evidence based treatment options for chloroquine resistant vivax malaria. This study will also provide information about prevalence of glucose-6-phosphate dehydrogenase (G6PD) deficiency and G6PD variants in North Sumatera population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
331

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

January 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

August 29, 2013

Status Verified

August 1, 2013

Enrollment Period

1.2 years

First QC Date

February 1, 2011

Last Update Submit

August 28, 2013

Conditions

Vivax Malaria

Outcome Measures

Primary Outcomes (1)

  • Assessment of cure rate of both arms AS-AQ + PQ and DHP+PQ

    Evaluate the relative efficacy of the study drugs in providing parasite clearance over the observation period of 42 days.

    42 days

Secondary Outcomes (1)

  • To assess the effects of drugs on parasite clearance and malaria associated symptoms

    42 days

Study Arms (2)

DHP+PQ

EXPERIMENTAL

Dihydroartemisinin 2.25mg/kg and piperaquine 16-18mg/kg on day 0, 1, and 2 and primaquine 15 mg/kg form day 0-13.

Drug: Dihydroartemisinin/piperaquine + primaquine

AS-AQ +PQ

ACTIVE COMPARATOR

Standard treatment with artesunate-amodiaquine plus primaquine, with artesunate 4mg/kg and amodiaquine 10mg/kg on day 0, 1, and 2 and primaquine 15 mg/kg form day 0-13.

Drug: Artesunate-amodiaquine + primaquine

Interventions

Dihydroartemisinin/piperaquine + primaquineDRUG

Dihydroartemisinin 2.25mg/kg and piperaquine 16-18mg/kg on day 0, 1, and 2 and primaquine 15 mg/kg form day 0-13.

DHP+PQ
Artesunate-amodiaquine + primaquineDRUG

Standard treatment with artesunate-amodiaquine plus primaquine, with artesunate 4mg/kg and amodiaquine 10mg/kg on day 0, 1, and 2 and primaquine 15 mg/kg form day 0-13.

AS-AQ +PQ

Eligibility Criteria

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

You may qualify if:

  • Both sex
  • Age \> 1 year
  • Fever (axillary temp ≥ 37.5oC) or history of fever during the preceding 48 hours
  • Uncomplicated Plasmodium vivax confirm by microscopic examination
  • Asexual parasite ≥ 250/µL blood
  • Absence of clinical condition that need hospitalization
  • No history of allergy to antimalarial drug
  • Not consuming antibiotic with antimalarial activity

You may not qualify if:

  • Clinical features of severe malaria
  • Severe malnutrition
  • Recurrent vomiting
  • Concomitant infection
  • Pregnant (test for β-HCG in women of child bearing age)
  • Lactating mother
  • Move out from study area
  • Not eligible to follow up during study period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labuhan Batu Utara Regency Tanjung leidong village

North Sumatra, North Sumatera, Indonesia

Location

Related Publications (1)

  • Pasaribu AP, Chokejindachai W, Sirivichayakul C, Tanomsing N, Chavez I, Tjitra E, Pasaribu S, Imwong M, White NJ, Dondorp AM. A randomized comparison of dihydroartemisinin-piperaquine and artesunate-amodiaquine combined with primaquine for radical treatment of vivax malaria in Sumatera, Indonesia. J Infect Dis. 2013 Dec 1;208(11):1906-13. doi: 10.1093/infdis/jit407. Epub 2013 Aug 6.

    PMID: 23926329DERIVED

MeSH Terms

Conditions

Malaria, Vivax

Interventions

artenimolpiperaquinePrimaquineamodiaquine, artesunate drug combination

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Ayodhia Pitaloka Pasaribu, MD

    Department of Pediatric, Sumatera Utara University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2011

First Posted

February 2, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 29, 2013

Record last verified: 2013-08

Locations

ID(1)