NCT03384472

Brief Summary

This study is to determine the prevalence and geographical distribution of antimalarial drug resistance-linked genetic mutations in clinical P. falciparum infections in Cambodia

Trial Health

100
On Track

Trial Health Score

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

Enrollment
185

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2016

Shorter than P25 for all trials

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

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
11 months until next milestone

First Posted

Study publicly available on registry

December 27, 2017

Completed
Last Updated

May 24, 2022

Status Verified

December 1, 2017

Enrollment Period

8 months

First QC Date

August 22, 2016

Last Update Submit

May 17, 2022

Conditions

Keywords

Malaria Genetic SurveillanceCambodia

Outcome Measures

Primary Outcomes (1)

  • Annual maps and reports on the prevalence of drug resistance-linked genetic mutations in P. falciparum parasites in Cambodia

    up to 12 months

Secondary Outcomes (3)

  • Population structure of P.falciparum parasites

    up to 12 months

  • Gene flow patterns of P. falciparum malaria parasites in Cambodia

    up to 12 months

  • Likely geographic origin of P. falciparum malaria parasites in Cambodia

    up to 12 months

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients \> 6 months of age with P. falciparum malaria who present to village malaria workers and health centres in Stung Treng and Ratanakiri provinces in Cambodia are the target study population. 2014 data suggest this could amount to up to 7,000 patients per year. All study participants must satisfy the applicable inclusion and exclusion criteria

You may qualify if:

  • Male or female \>6 months of age
  • P. falciparum malaria as confirmed by positive rapid diagnostic test or asexual forms of P. falciparum on blood smear microscopy (may be mixed with non-falciparum Plasmodium species)
  • Written informed consent by patient, parent/guardian, or legally authorised representative to participate in the study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Jacob CG, Thuy-Nhien N, Mayxay M, Maude RJ, Quang HH, Hongvanthong B, Vanisaveth V, Ngo Duc T, Rekol H, van der Pluijm R, von Seidlein L, Fairhurst R, Nosten F, Hossain MA, Park N, Goodwin S, Ringwald P, Chindavongsa K, Newton P, Ashley E, Phalivong S, Maude R, Leang R, Huch C, Dong LT, Nguyen KT, Nhat TM, Hien TT, Nguyen H, Zdrojewski N, Canavati S, Sayeed AA, Uddin D, Buckee C, Fanello CI, Onyamboko M, Peto T, Tripura R, Amaratunga C, Myint Thu A, Delmas G, Landier J, Parker DM, Chau NH, Lek D, Suon S, Callery J, Jittamala P, Hanboonkunupakarn B, Pukrittayakamee S, Phyo AP, Smithuis F, Lin K, Thant M, Hlaing TM, Satpathi P, Satpathi S, Behera PK, Tripura A, Baidya S, Valecha N, Anvikar AR, Ul Islam A, Faiz A, Kunasol C, Drury E, Kekre M, Ali M, Love K, Rajatileka S, Jeffreys AE, Rowlands K, Hubbart CS, Dhorda M, Vongpromek R, Kotanan N, Wongnak P, Almagro Garcia J, Pearson RD, Ariani CV, Chookajorn T, Malangone C, Nguyen T, Stalker J, Jeffery B, Keatley J, Johnson KJ, Muddyman D, Chan XHS, Sillitoe J, Amato R, Simpson V, Goncalves S, Rockett K, Day NP, Dondorp AM, Kwiatkowski DP, Miotto O. Genetic surveillance in the Greater Mekong subregion and South Asia to support malaria control and elimination. Elife. 2021 Aug 10;10:e62997. doi: 10.7554/eLife.62997.

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Dried blood spots (DBS) will be obtained through finger prick blood sampling from patients, with three blood spots on one piece of filter paper being obtained from each patient. Each blood spot will contain \~20µl of blood, for a total of \~60µl of blood being collected from each patient for the study.

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

December 27, 2017

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

May 24, 2022

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will share

Anonymised data recorded in the CRFs will be shared via open access online repositories as per the requirements of the journal in which the results of the study are published.