NCT02118090

Brief Summary

The investigators propose to leverage the unique infrastructures and expertise of National Centre for Parasitology Entomology and Malaria Control and the Pasteur Institute in Cambodia and combine modern fieldwork, including a mobile laboratory fully equipped for molecular biology and culture experiments, with state-of-the-art genomic analyses to investigate how Plasmodium vivax parasites respond to antimalarial drugs. The investigators will focus on resistance to CQ, the choice treatment for vivax malaria in most endemic countries, for which treatment failures have been reported in Cambodia. The study will address some of the key biological mechanisms limiting the efficiency of drug therapy in P. vivax, including the identification of genetic polymorphisms underlying drug resistance in Cambodian P. vivax. The findings will provide a first unbiased perspective on the mechanisms of drug resistance in P. vivax and have the strong potential to significantly improve malaria control in Southeast Asia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2014

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 14, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2014

Completed
10 days until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

April 14, 2014

Last Update Submit

March 23, 2015

Conditions

Vivax Malaria

Keywords

malariaPlasmodium vivaxdrug resistancechloroquineCambodia

Outcome Measures

Primary Outcomes (1)

  • Number of patients with P. vivax CQ resistant parasite

    Based on parasite clearance time (slow versus fast clearers) and treatments failure (according to the CQ blood concentration)

    6 months

Secondary Outcomes (1)

  • Number of isolates characterized by whole genome sequencing and multiple Single Nucleotide Polymorphisms Bar Code

    1 year

Study Arms (2)

Chloroquine

EXPERIMENTAL

Patients treat with chloroquine sulfate (NIVAQUINE) 10 mg/kg/day - 3 days

Drug: Chloroquine sulfate

DHA-PP

ACTIVE COMPARATOR

Patient treat with DHA 40 mg and PP 320 mg, (Duo-Cotecxin®) The approximate total adult dose is 2-4 mg/kg for DHA and 20mg/kg for PP

Drug: DHA-PP

Interventions

Chloroquine sulfateDRUG

Chloroquine sulfate (NIVAQUINE) - 30 mg/kg for 3 days

Also known as: NIVAQUINE
Chloroquine
DHA-PPDRUG

DHA-PIP (Duo-Cotecxin®, DHA 40 mg and PP 320 mg, Zhejiang Holley Nanhu Pharamaceutical Co. Ltd, Jiaxing, Zhejiang province, China): one tablet of DHA-PIP contains 40 mg of dihydroartemisinin (DHA) and 320 mg piperaquine (PIP). It is an oral administration, one dose a day for 3 consecutive days. An adult dose (≥40 kg to 60kg body weight or more than 15 years old) consisted of three doses of 3 tablets over consecutive days (Total dose 9 tablets). The approximate total adult dose was 2-4 mg/kg for DHA and 20mg/kg for PP.

Also known as: Duo-Cotecxin
DHA-PP

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • (i) Being aged 15 years or more with competency to give informed consent, (ii) Being positive for P. vivax and mono-infected

You may not qualify if:

  • (i) Being aged 14 years or less (ii) Individuals with illness that affected competency to give informed consent, (iii) Pregnant or lactating women (iv) Having taken antimalarial drugs in the past month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Provincial Hospital

Banlung, Ratanakiri, Cambodia

Location

Related Publications (1)

  • Popovici J, Friedrich LR, Kim S, Bin S, Run V, Lek D, Cannon MV, Menard D, Serre D. Genomic Analyses Reveal the Common Occurrence and Complexity of Plasmodium vivax Relapses in Cambodia. mBio. 2018 Jan 23;9(1):e01888-17. doi: 10.1128/mBio.01888-17.

    PMID: 29362233DERIVED

MeSH Terms

Conditions

Malaria, VivaxMalaria

Interventions

Chloroquine2,6-diisopropylphenol docosahexaenoate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Dysoley Lek, MD

    National Centre for Parasitology Entomology and Malaria Control

    PRINCIPAL INVESTIGATOR

  • Didier Ménard, PharmD, PhD

    Institut Pasteur in Cambodia

    PRINCIPAL INVESTIGATOR

  • Jean Popovici, PhD

    Institut Pasteur in Cambodia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Malaria Molecular Epidemiology Unit

Study Record Dates

First Submitted

April 14, 2014

First Posted

April 21, 2014

Study Start

May 1, 2014

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

CA(1)