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Plasmodium Falciparum Artemisinin Resistance Vietnam

Sponsor
National Institute of Malariology, Parasitology and Entomology, Vietnam (Other)
Overall Status
Completed
CT.gov ID
NCT01775592
Collaborator
Institute of Tropical Medicine, Belgium (Other)
95
Enrollment
1
Location
1
Arm
4
Duration (Months)
23.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Arterakin (DHA-PPQ)
 Phase 4

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 Design

Study Type:
Interventional
Actual Enrollment :
95 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Jan 1, 2013
Actual Study Completion Date :
Jan 1, 2013

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

  1. Parasite clearance time [Day 2-5]

Secondary Outcome Measures

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

    treatment failure or success at day 42

  2. in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province [Day 3-10]

    MarkIII in vitro test

Other Outcome Measures

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

    genotyping

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Months and Older
Sexes Eligible for Study:
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:

  • 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

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Institute of Malariology, Parasitology and Entomology, Vietnam
ClinicalTrials.gov Identifier:
NCT01775592
Other Study ID Numbers:
  • NIMPE - ITM
First Posted:
Jan 25, 2013
Last Update Posted:
Jan 28, 2013
Last Verified:
Jan 1, 2013
Keywords provided by National Institute of Malariology, Parasitology and Entomology, Vietnam
P.f resistance
Additional relevant MeSH terms:
Malaria

Study Results

No Results Posted as of Jan 28, 2013