Plasmodium Falciparum Artemisinin Resistance Vietnam

January 25, 2013 updated by: National Institute of Malariology, Parasitology and Entomology, Vietnam

Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam

Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. The investigators therefore aim to assess parasite clearance in malaria patients in central Vietnam when treated according to national standard guidelines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

General objective To evaluate the efficacy of DHA-PPQ in patients with uncomplicated falciparum malaria in a rural area of Central Vietnam, and to assess the in vitro susceptibility of P.falciparum isolates to DHA and PPQ.

Specific objectives

  1. To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ.
  2. To determine the efficacy of DHA-PPQ at day 42 post-treatment.
  3. To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province.
  4. To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;

Study Type

Interventional

Enrollment (Actual)

95

Phase

  • 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
    • Quang Nam
      • Tra Leng, Quang Nam, Vietnam
        • Health Centre Tra Leng

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

Ages Eligible for Study

2 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: from 6 months of age;
  • Fever (body temperature above 37.5C) or history of fever in the previous 24 hours;
  • Mono-infection with P.falciparum with parasite density between 500-100,000/µl
  • Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian.

Exclusion Criteria:

  • Mixed malaria infection;
  • Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating);
  • Concomitant acute illness necessitating specific treatment (antibiotics);
  • Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS).
  • Severe malnutrition;

  • Danger signs:

    • not able to drink
    • incontrollable vomiting
    • recent history of convulsions (>1 in 24 hours)
    • unconscious state; neurological impairment
    • unable to sit or stand

  • Signs of severe malaria:

    1. Cerebral malaria (unrousable coma)
    2. Severe anaemia (Htc< 15%)
    3. Renal failure (serum creatinine > 3 mg/dL)
    4. Pulmonary oedema;
    5. Hypoglycemia (<40mg/dL)
    6. Shock (systolic BP < 70 mmHg in adults, 50 in children)
    7. Spontaneous bleeding
    8. Repeat generalized convulsions
    9. Macroscopic haemoglobinuria
    10. Severe jaundice
  • Persons who have received quinine, artemisinin or artemisinin derivatives within the last 7 days, 4-aminoquinolines within the last 14 days, pyrimethamine and/or sulfonamides within the last 28 days, or mefloquine within the last 56 days should be excluded from the in vitro testing

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: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Arterakin

Number of DHA- PPQ (Arterakin™) tablets per day at 0hour, 8hours, 24hours, 48hours (according to age): 2 - 3 years:0.5, 0.5, 0.5, 0.5 3 - < 8 years: 1.0, 1.0, 1.0, 1.0 8 - < 15 years:1.5, 1.5, 1.5, 1.5

≥ 15 years:2.0, 2.0, 2.0, 2.0
Drug: Arterakin (DHA-PPQ)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Parasite clearance time
Time Frame: Day 2-5
Day 2-5

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam
Time Frame: Day 42
treatment failure or success at day 42
Day 42
in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province
Time Frame: Day 3-10
MarkIII in vitro test
Day 3-10

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance
Time Frame: 1year
genotyping
1year

Collaborators and Investigators

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

Sponsor

National Institute of Malariology, Parasitology and Entomology, Vietnam

Collaborators

Institute of Tropical Medicine, Belgium

Investigators

  • Principal Investigator: Annette Erhart, MD, PhD, ITM

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

September 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

January 1, 2013

Study Registration Dates

First Submitted

January 11, 2013

First Submitted That Met QC Criteria

January 22, 2013

First Posted (ESTIMATE)

January 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIMPE - ITM

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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