Plasmodium Falciparum Artemisinin Resistance Vietnam

This study has been completed.
Sponsor:
Collaborator:
Institute of Tropical Medicine, Belgium
Information provided by (Responsible Party):
National Institute of Malariology, Parasitology and Entomology, Vietnam
ClinicalTrials.gov Identifier:
NCT01775592
First received: January 11, 2013
Last updated: January 25, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention Phase
Plasmodium Falciparum
Drug: Arterakin (DHA-PPQ)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam

Resource links provided by NLM:


Further study details as provided by National Institute of Malariology, Parasitology and Entomology, Vietnam:

Primary Outcome Measures:
  • Parasite clearance time [ Time Frame: Day 2-5 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam [ Time Frame: Day 42 ] [ Designated as safety issue: No ]
    treatment failure or success at day 42

  • in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province [ Time Frame: Day 3-10 ] [ Designated as safety issue: No ]
    MarkIII in vitro test


Other Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    genotyping


Enrollment: 95
Study Start Date: September 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)
NA

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;
  Eligibility

Ages Eligible for Study:   2 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01775592

Locations
Vietnam
Health Centre Tra Leng
Tra Leng, Quang Nam, Vietnam
Sponsors and Collaborators
National Institute of Malariology, Parasitology and Entomology, Vietnam
Institute of Tropical Medicine, Belgium
Investigators
Principal Investigator: Annette Erhart, MD, PhD ITM
  More Information

No publications provided

Responsible Party: National Institute of Malariology, Parasitology and Entomology, Vietnam
ClinicalTrials.gov Identifier: NCT01775592     History of Changes
Other Study ID Numbers: NIMPE - ITM
Study First Received: January 11, 2013
Last Updated: January 25, 2013
Health Authority: Vietnam: Ministry of Health

Keywords provided by National Institute of Malariology, Parasitology and Entomology, Vietnam:
P.f resistance

ClinicalTrials.gov processed this record on September 16, 2014