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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01775592
Other study ID # NIMPE - ITM
Secondary ID
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


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
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