Plasmodium Falciparum Artemisinin Resistance Vietnam

Phase 4

Completed

• Conditions: Plasmodium Falciparum
• Interventions: Drug: Arterakin (DHA-PPQ)

• Registration Number: NCT01775592
• Lead Sponsor: National Institute of Malariology, Parasitology and Entomology, Vietnam

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.

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 Timeline

• Study Start: 2012-09
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-25
• Last Update Submitted: 2013-01-25
• Last Update Posted: 2013-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arterakin	Arterakin (DHA-PPQ)	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

Primary Outcome Measures

Name	Time	Method
Parasite clearance time	Day 2-5

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Health Centre Tra Leng; 🇻🇳 Tra Leng, Quang Nam, Vietnam