Prevention of Malaria With Dihydroartemisinine + Piperaquine for Forest Rangers (PREMAL)

March 6, 2017 updated by: Oxford University Clinical Research Unit, Vietnam

A Randomized, Placebo-controlled, Double-blind Trial Using Dihydroartemisinine+Piperaquine (DP) to Protect Forest Workers From Malaria in Bu Gia Map National Park

The purpose of the study is to assess if the antimalarial drugs Dihydroartemisinine + Piperaquine (DP) are effective in preventing malaria infection for forest ranger

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

To assess the protective effect of 3-day DP regimen for forest rangers working for long-term in forest where malaria transmission is intense, all eligible forest rangers will be treated with a full course of DP + primaquine to eradicate all parasites which may survive in their blood while staying in non- malaria transmission areas.

Just before returning back to the forest participants will be randomized to receive either Arterakine (dihydroartemisinine (DHA)/piperaquine) (intervention arm) or placebo (control arm). Participants will be assessed for parasitemia before and after the forest trip with high volume, ultrasensitive, PCR (HVUqPCR). The minimum time span between two forest trips should be 20 days so participants could complete the 14 day primaquine course and the Arterakine (dihydroartemisinine (DHA)/piperaquine).

There is no limit in the duration between trips. Participants are tested for P.falciparum, P.vivax infection before they return to the forest.

Each participant will be visited 2 weeks or later after returning home from the forest and examined. The rationale for the added two weeks is to detect blood stages of infections, which may have been inoculated towards the end of the forest visit.

If found to be sick, the patient will be treated according to government treatment guidelines. A 4ml venous blood sample will be obtained for Hb and HVUSqPCR.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Binh Phuoc, Vietnam, 830000
        • Bu Gia Map Commune Health Station

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Informed consent
  2. Male, over or equal to18 years of age
  3. Able and willing to comply with the study requirements and follow-up

Exclusion Criteria:

  1. Inability to tolerate oral treatment
  2. Previous episode of haemolysis or severe haemoglobinuria following primaquine
  3. Glucose-6-phosphate dehydrogenase (G6PD) deficient with Hb < 9 g/dL *
  4. Known hypersensitivity or allergy to any study drugs * If the participant with G6PD deficient gets malaria, primaquine would be used as recommended by World Health Organization (WHO) (once a week for 8 weeks) in combination with 3 days of chloroquine.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Arterakine
Active drug: Arterakine (DHA/piperaquine) one tablet contains 40 mg of dihydroartemisinin and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinin; 55 mg/kg piperaquine phosphate) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)
Drug: Arterakine (DHA/piperaquine)

Stage 1: Parasite Clearance

  • Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days
  • Primaquine (One tablet contains 13.2mg primaquine disphosphate/7.5mg base. Weight based regimen: 0.25mg base/kg) for 14 days

Stage 2: Forest trip

• Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)
Placebo Comparator: Placebo
Placebo (visually matched to Arterakine for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)
Drug: Placebo

Stage 1: Parasite Clearance

  • Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days
  • Primaquine (One tablet contains 13.2mg primaquine disphosphate/7.5mg base. Weight based regimen: 0.25mg base/kg) for 14 days

Stage 2: Forest trip

• Placebo (visually matched to Arterakine (DHA/piperaquine) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
the proportion of study subjects with any malaria parasitaemia (P.falciparum, mixed parasitaemia of P.falciparum and P.vivax) and the incidence rate of symptomatic malaria
Time Frame: at 2 weeks after coming back from the forest
The primary endpoints are the proportion of study subjects with any malaria parasitaemia (P.falciparum, mixed parasitaemia of P.falciparum and P.vivax) at 2 weeks after coming back from the forest assessed by high volume, ultrasensitive PCR (HVUSqPCR) and the incidence rate of symptomatic malaria (P.falciparum, mixed P.falciparum + P.vivax) during the two week follow-up period as assessed by the study doctor.
at 2 weeks after coming back from the forest

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of different anopheles species amongst all captured mosquito anopheles
Time Frame: 1 month
The proportion of different anopheles species amongst all captured mosquito anopheles as identified by morphology
1 month
The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax)
Time Frame: 6 months
The proportion of sporozoite-carrying mosquitoes (any parasite, P.falciparum, mixed P.falciparum and P.vivax) as assessed by PCR.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Oxford University Clinical Research Unit, Vietnam

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Binh Phuoc Malaria Control Centre
Bu Gia Map National Park, Binh Phuoc Province, Vietnam

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hung Son Do, Dr, Oxford University Clinical Research Unit

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 2, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17MA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual participant data will be made available to researcher and public as a supporting material via open access journal and/or upon request by qualified research groups.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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