Plasmodium Falciparum Artemisinin Resistance Vietnam

Plasmodium Falciparum Clinical Trial

Official title:

Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01775592
• Other study ID #: NIMPE - ITM
• Status: Completed
• Phase: Phase 4
• First received: January 11, 2013
• Last updated: January 25, 2013
• Start date: September 2012
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: National Institute of Malariology, Parasitology and Entomology, Vietnam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Vietnam: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Months and older

Eligibility

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 ß 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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Malaria
• Plasmodium Falciparum

Intervention

Drug:
• Arterakin (DHA-PPQ)

Locations

Country	Name	City	State
Vietnam	Health Centre Tra Leng	Tra Leng	Quang Nam

Sponsors (2)

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

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance	genotyping	1year	No
Primary	Parasite clearance time		Day 2-5	No
Secondary	efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam	treatment failure or success at day 42	Day 42	No
Secondary	in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province	MarkIII in vitro test	Day 3-10	No