Plasmodium Falciparum Artemisinin Resistance Vietnam

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Malariology, Parasitology and Entomology, Vietnam
• Collaborator: Institute of Tropical Medicine, Belgium

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