NCT02895568

Brief Summary

This study is to measure prevalence of established and candidate molecular markers of drug resistant malaria at Komé, Doba, Republic of Chad.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
399

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

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

August 22, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 9, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

September 16, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 6, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 6, 2018

Completed
Last Updated

April 7, 2022

Status Verified

November 1, 2018

Enrollment Period

2 years

First QC Date

August 22, 2016

Last Update Submit

March 29, 2022

Conditions

Plasmodium Falciparum

Keywords

Antimalarial drugResistanceRepublic of Chard

Outcome Measures

Primary Outcomes (1)

  • Percent prevalence of kelch13 mutants (marker of resistance to artemisinins)

    2 years

Secondary Outcomes (2)

  • Percent prevalence of specimens with pfmdr1 copy number >1 (marker of resistance to mefloquine)

    2 years

  • Visualization and dissemination of molecular marker prevalence data to inform public health officials, researchers, policymakers and key stakeholders

    2 yeas

Eligibility Criteria

Age6 Months - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be the patients presenting at study clinics with signs and symptoms of malaria (including but not limited to headache, body aches, fever, chills, and weakness) and confirmed P. falciparum infection.

You may qualify if:

  • Patients (6 months - 75 years) with confirmed uncomplicated P. falciparum infection
  • Written informed consent obtained

You may not qualify if:

  • Patients presenting signs of severe malaria will be excluded from the survey to prevent any delay in the management of the patient.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study clinic

Komé, Doba, Chad

Location

Related Publications (1)

  • Das S, Kerah-Hinzoumbe C, Kebfene M, Srisutham S, Nagorngar TY, Saralamba N, Vongpromek R, Khomvarn T, Sibley CH, Guerin PJ, Imwong M, Dhorda M. Molecular surveillance for operationally relevant genetic polymorphisms in Plasmodium falciparum in Southern Chad, 2016-2017. Malar J. 2022 Mar 12;21(1):83. doi: 10.1186/s12936-022-04095-9.

    PMID: 35279140BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

A dried blood spot sample for study analyses will be collected at the time of blood collection for malaria diagnostic testing.

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

September 9, 2016

Study Start

September 16, 2016

Primary Completion

September 6, 2018

Study Completion

September 6, 2018

Last Updated

April 7, 2022

Record last verified: 2018-11

Locations

CH(1)