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CompletedNCT01775592Updated Jan 28, 2013

Plasmodium Falciparum Artemisinin Resistance Vietnam

A Phase 4 interventional study of Arterakin (DHA-PPQ) in Plasmodium Falciparum, sponsored by National Institute of Malariology, Parasitology and Entomology, Vietnam. Completed at 1 site in Vietnam. Open to participants aged 2 Months and older. Per ClinicalTrials.gov, last updated 2013-01-28.

Sponsored by National Institute of Malariology, Parasitology and Entomology, Vietnam · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
95
Allocation
Not applicable
Ages
2 Months and older
Sex
All
01

Study summary

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.

Read the 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;
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Conditions studied

  • Plasmodium Falciparum

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Keywords

  • P.f resistance
03

In context

Malaria

1,299 studies on the registry are indexed under Malaria; 86 are open to participants now.

This study's enrollment of 95 is below the median of 220 across 1,027 interventional studies indexed under Malaria.

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Lead sponsor

National Institute of Malariology, Parasitology and Entomology, Vietnam is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
2 Months and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
95 participants (actual)

Study arms

  • 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)

Interventions

  • DrugArterakin (DHA-PPQ)
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What researchers measure

Primary outcomes

  1. Parasite clearance time

    Time frame: Day 2-5

Secondary outcomes

  1. efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam

    treatment failure or success at day 42

    Time frame: Day 42

  2. in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province

    MarkIII in vitro test

    Time frame: Day 3-10

Other outcomes

  1. genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance

    genotyping

    Time frame: 1year

07

Study locations

1 site
  • Health Centre Tra Leng
    Tra Leng, Quang Nam, Vietnam
08

References and documents

Publications

  • Thriemer K, Hong NV, Rosanas-Urgell A, Phuc BQ, Ha do M, Pockele E, Guetens P, Van NV, Duong TT, Amambua-Ngwa A, D'Alessandro U, Erhart A. Delayed parasite clearance after treatment with dihydroartemisinin-piperaquine in Plasmodium falciparum malaria patients in central Vietnam. Antimicrob Agents Chemother. 2014 Dec;58(12):7049-55. doi: 10.1128/AAC.02746-14. Epub 2014 Sep 15. PubMed 25224002 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 28, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01775592
Lead sponsor
National Institute of Malariology, Parasitology and Entomology, Vietnam
Collaborators
Institute of Tropical Medicine, Belgium
Responsible party
Sponsor
First posted
Jan 25, 2013
Start date
Sep 2012
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Jan 28, 2013

Study contacts

Annette Erhart, MD, PhD
principal investigator · ITM

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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